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Lifeline Glossary

Following is a list of selected life science terms and their brief definitions. We will try to add new terms as often as we can.

21CFR Part 820: FDA regulation covering Medical Devices - Quality System Regulation.

FDA filing to obtain clearance to market a medical device.

Established in 1947, AABB (formerly known as the American Association of Blood Banks) is an international, not-for-profit association dedicated to the advancement of science and the practice of transfusion medicine and related biological therapies.

Acceptance Activity: FDA 21CFR Part 820 SubPart H Sec. 820.80 Receiving, in-process, and finished device acceptance. Each manufacturer shall establish and maintain procedures for acceptance activities. Acceptance activities include inspections, tests, or other verification activities.

Acceptance Record: Each manufacturer shall document acceptance activities required by 21 CFR Part 820. These records shall include:

  1. The acceptance activities performed;
  2. the dates acceptance activities are performed;
  3. the results;
  4. the signature of the individual(s) conducting the acceptance activities; and
  5. where appropriate the equipment used. These records shall be part of the DHR.

ADUFA: The Animal Drug User Fee Act, a 2003 amendment of the Federal Food, Drug and Cosmetic Act allows the FDA to garner fees in association with particular animal drug applications. The act also allows the FDA to garner fees for the sponsors, establishments and products associated with said drug applications.

Adverse Event: For clinical study trials performed under GCP, Adverse Events (AE) or experiences are defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered associated with the use of the study drug. This includes any signs, symptoms, inter-current illnesses, clinically significant alteration in laboratory values, and any significant worsening of the disease under study, regardless of whether the event is considered to be related to the investigational study drug or to a concomitant medication.

AERS: The Adverse Event Reporting System is a computerized information database designed to support the FDA's post-marketing surveillance program for all approved drug and therapeutic products.

ANDA: Abbreviated New Drug Application is the application for approval to market a generic drug.

Animal Pharmacology & Toxicology: Pre-clinical development is a stage in the development of a new drug that begins before clinical trials (testing in humans) can begin, and during which important safety and pharmacology data is collected. The main goals of pre-clinical studies are to determine a drug's pharmacodynamics (PD), pharmacokinetics (PK), ADME, and toxicity through animal testing.

Approvable Letter: An approvable letter from the FDA requires that a filing applicant meet specific conditions before FDA approval can be obtained.

AOQ: Automated Operational Qualification Validation scripts run on a client installation.

API (1): Application Programming Interface.

API (2): An active ingredient, also active pharmaceutical ingredient (or API), is the substance in a drug that is pharmaceutically active. Some medications may contain more than one active ingredient. The traditional word for the API is pharmacon (from Greek: (f??µa???), adapted from pharmacos) which originally denoted a magical substance or drug. A dosage form of a drug is traditionally composed of two things: The API, which is the drug itself; and an excipient, which is the substance of the tablet, or the liquid the API is suspended in, or other material that is pharmaceutically inert. Drugs are chosen primarily for their active ingredients.

ARC: Audit Repository Center.

ASCP: American Society for Clinical Pathology.

ASP: Application Service Provider.

ASQ: American Society for Quality.

Audit: An audit is an evaluation of an organization, system, process, project, or product. Audits are performed to ascertain the validity and reliability of financial information, and also provide an assessment of a company or a business' system of internal control. Such systems must adhere to generally accepted standards set by governing bodies that regulate businesses. An audit is based on random sampling and is not an assurance that financial statements are free from errors. It simply provides assurance for third parties or external users that such statements present 'fairly' a company's financial condition and results of operations. Auditing is a part of some quality control certifications such as ISO 9000.

BDP: Biological Product Deviation. The FDA requires the reporting of any biological product deviations, which refer to events that may affect the safety, purity, or potency of a distributed biological product.

Biotechnology Industry: Biotechnology is the use of biological processes, organisms, or systems to manufacture products intended to improve the quality of human life. The earliest biotechnologists were farmers who developed improved species of plants and animals by cross pollenization or cross breeding. In recent years, biotechnology has expanded in sophistication, scope, and applicability.

BLA: Biologic License Application is submitted by an applicant who wants to pursue a biological product.

Blind Study: Blinding is a basic tool to prevent conscious and unconscious bias in research. For example, study where the participants (subjects) do not know what they are receiving trial drug or placebo.

BMS: Business Management Software

BOM: A bill of materials or bill of material (abbreviated "BOM") describes a product in terms of its assemblies, sub-assemblies, and basic parts. Basically consisting of a list of parts, a BOM is an essential part of the design and manufacture of any product. Other terms by which a bill of material is known include the formula, recipe, or ingredients list in certain process industries. Often, BOMs contain hierarchical information with the master, or top level, BOM describing a list of components and sub-assemblies. Take a PC, for example: the top level BOM might list the shipping box, manual, packaging, packaging labels and the actual PC. The BOM for the PC itself is referenced in the top level BOM and would contain its own list of sub-assemblies like power supply, motherboard, case, etc.

With regard to any process industry this is a set of engineering documents containing information for identification, fabrication and construction of equipment, piping and piping components for a project or part of a project. Separate BOMs are prepared for the different material used for construction, e.g. carbon steel, stainless steel, GRP, insulating material, cladding etc.

CAD: The use of computer programs and systems to design detailed two- or three-dimensional models of physical objects, such as mechanical parts, buildings, and molecules.

CAPA: Stands for Corrective Action and Preventive Action. It is a systematic approach to correct, prevent, and eliminate the cause of potential nonconforming product and other quality problems. “Corrective” refers to a reaction or an activity meant to correct a nonconformance that has already occurred. “Preventive” refers to an action/activity meant to prevent recurrence of a nonconformance.

CAP: CAP Accreditation Beneficial for FDA-Regulated Blood Centers and Blood Establishments FDA-regulated blood centers, clinical laboratories, and related establishments are under tremendous pressure to maintain the highest standards for blood and tissue quality. The CAP Laboratory Accreditation Program is generally recognized as equal to, or more stringent than, the U.S. government's inspection program. The CAP Accreditation Program helps improve the quality of clinical laboratory services through voluntary participation, professional peer review, education, and compliance with established performance standards.Laboratories in different settings — from hospitals to contract research organizations —discover that CAP accreditation standards can help them set requirements on such things as leadership, physical facilities, safety, quality control, and performance improvement. A blood center's accreditation can increase the organization's motivation to strengthen processes meant to reduce the risks of blood contamination and infectious disease transmission. It can also serve as further proof of the blood center's high standards. In both the FDA and CAP environments, there are areas considered critical to quality improvement. Document control is one of them. The process for controlling the creation, review, approval, distribution, and revision of documents is as important in CAP accreditation as it is in FDA compliance.

CAM: The process of using specialized computers to control, monitor, and adjust tools and machinery in manufacturing.

CGMP/GMP: Current Good Manufacturing Practice regulations are enforced by the FDA to ensure that manufacturers’ operations are in a state of control and that their products are safe and reliable. The term was originally GMP. “C” refers to current technology.

CBER: The Center for Biologics Evaluation and Research, a part of the FDA, regulates biological and related products, including blood, vaccines, tissue, allergenics, and biological therapeutics.

CDER: The Center for Drug Evaluation and Research, a part of the FDA, evaluates new drugs before they can be sold. It is responsible for making sure that prescription and over-the-counter drugs work correctly and that their health benefits outweigh known risks.

CDRH: The Center for Devices and Radiological Health, a part of the FDA, is responsible for ensuring the safety and reliability of medical devices in the U.S. It also regulates radiation-emitting products, ranging from microwave ovens to X-ray machines.

Central Laboratory: In medicine, a clinical trial (synonyms: clinical studies, research protocols, medical research) is a type of research study. The most commonly performed clinical trials evaluate new drugs, medical devices, biologics, or other interventions on patients in strictly scientifically controlled settings, and are required for regulatory authority (in the USA, the Food and Drug Administration; in Canada, Health Canada; in the EU, the European Medicines Agency; in Japan, the Ministry of Health, Labour and Welfare (Japan)) approval of new therapies. Trials may be designed to assess the safety and efficacy of an xperimental therapy, to assess whether the new intervention is better than standard therapy, or to compare the efficacy of two standard or marketed interventions. The trial objectives and design are usually documented in a clinical trial protocol. Pharmaceutical clinical trials are commonly classified into four phases, and the drug-development process will normally proceed through all four stages over many years. If the drug successfully passes through the Phases I, II, and III, it will usually be approved for use in the general population.

Clinical Trial: A test to help determine if a treatment is safe and effective. The different stages are: Phase I (20-80 volunteers); Phase II (100-300 patients); Phase III (1,000-3,000 patients in controlled and uncontrolled environments). Phase IV (additional testing after a drug has been approved).

Code of Federal Regulations (CFR): General and permanent rules published in the U.S. Federal Register by the executive department and agencies of the U.S. federal government.

CMO: Chief Medical Officer

CMS: Centers for Medicare & Medicaid Services (CMS), previously known as the Health Care Financing Administration (HCFA), is a federal agency within the United States Department of Health and Human Services (DHHS) that administers the Medicare program and works in partnership with State governments to administer Medicaid, the State Children's Health Insurance Program (SCHIP), and health insurance portability standards. In addition to these programs, CMS has other responsibilities, including the administrative simplification standards from the Health Insurance Portability and Accountability Act of 1996 (HIPAA), quality standards in long-term care facilities (more commonly referred to as nursing homes) through its survey and certification process, and clinical laboratory quality standards under the Clinical Laboratory Improvement Amendments.

COBIT: Control Objectives for Information and related Technology (control matrix for SOX compliance)

Compliance: Adherence to regulatory requirements

Combination Product:A product composed of two or more regulated components (e.g., drug/device, biologic/device) that are physically, chemically, or otherwise combined or mixed and produced as a single entity.

Common Technical Document (CTD): A specification for applications for drug approval designed to be used across Europe, Japan , and the United States . It is maintained by the International Conference on Harmonization (ICH).

Connections: MasterControl Document Connections allows companies to integrate their existing electronic repositories ECM, PLM, or other types — with MasterControl Training™, MasterControl CAPA™, MasterControl Forms™, and other cutting-edge MasterControl applications. By using this module, integration of MasterControl solutions with external repositories can be made easily and immediately, without expensive custom coding.

COSO: Committee of Sponsoring Organizations

CSIA: Cyber Security Industry Alliance

COTS: Configurable Off The Shelf (also Configurable/Customizable Off The Shelf)

CQA: ASQ Certified Quality Auditor

CRM: Enterprise-wide software applications that allow companies to manage every aspect of their relationship with a customer. The aim of these systems is to assist in building lasting customer relationships - to turn customer satisfaction into customer loyalty. Customer information acquired from sales, marketing, customer service, and support is captured and stored in a centralised database. The system may provide data-mining facilities that support an opportunity management system. It may also be integrated with other systems such as accounting and manufacturing for a truly enterprise-wide system with thousands of users.

CRO: A Contract Research Organization (CRO) is an organization that offers clients a wide range of pharmaceutical research services. In the Code of Federal Regulations (CFR), the U.S. Food and Drug Administration regulations state that a CRO is "a person [i.e., a legal person, which may be a corporation] that assumes, as an independent contractor with the sponsor, one or more of the obligations of a sponsor, e.g., design of a protocol, selection or monitoring of investigations, evaluation of reports, and preparation of materials to be submitted to the Food and Drug Administration." [21 CFR 312.3(b)]" Services offered by CROs include: product development and formulation, clinical trial management (preclinical through phase IV), central laboratory services for processing trial samples, data management services for preparation of an FDA New Drug Application (NDA) or an Abbreviated New Drug Application (ANDA), and many other complementary services. CROs can offer their clients the experience of moving a new drug from its conception to FDA marketing approval without the drug sponsor having to maintain a staff for these services, which often have limited duration.

CTD: A format or organization structure for the data that is presented to the FDA in the NDA. Developed in concert with the EU and Japan.
The goal was to provide re-usability of the information within the NDA (or other application) to other governing bodies. Divided into modules or sections. Module 1 is region/agency specific information. Other modules/ sections have significant re-use.

Continuous Validation: For FDA-regulated companies, MasterControl offers a “continuous validation” approach that dramatically cuts the time, pain, and cost involved in validation. MasterControl's continuum of innovative products and services include MasterControl Transfer OQ and MasterControl Automated OQ.

Consent Decree of Condemnation:
A document entered by the court on a seizure action based on a claimant’s agreement that the article seized is in violation as alleged in the Complaint for Forfeiture and the article is subject to condemnation. It is also a declaration of the claimant’s intent to provide a bond and to recondition the article under FDA supervision and to pay the costs.

CVM: Center for Veterinary Medicine

CSV: Computer System Validation

DHS: Department of Homeland Security

DDP: Design and Development Plan

Design Input: Design input. Each manufacturer shall establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient. The procedures shall include a mechanism for addressing incomplete, ambiguous, or conflicting requirements. The design input requirements shall be documented and shall be reviewed and approved by a designated individual(s). The approval, including the date and signature of the individual(s) approving the requirements, shall be documented.

Design Review: Design Review means a documented, comprehensive, systematic examination of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems.

Design Validation: Design validation means establishing by objective evidence that device specifications conform with user needs and intended use(s).

Design Verification: Design Verification. Each manufacturer shall establish and maintain procedures for verifying the device design. Design verification shall confirm that the design output meets the design input requirements. The results of the design verification, including identification of the design, method(s), the date, and the individual(s) performing the verification, shall be documented in the DHF.

DHF: Design History File. Each manufacturer shall establish and maintain a DHF for each type of device. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part.

DHR: Device history record (DHR) means a compilation of records containing the production history of a finished device.

EDMS: Electronic Data Management System

DMS: Data/Database Management System

Discovery & Screening: The goal of early stages of pharmaceutical development is to identify novel chemical entities which might be developed into a new drug. This cannot be contracted out.

DMR: Device master record (DMR) means a compilation of records containing the procedures and specifications for a finished device.

Double-Blind Study: In a double-blind experiment, neither the individuals nor the researchers know who belongs to the control group and the experimental group.

Depth of Recall:(See recall below.) It refers to the level in the distribution chain to which the recall is to extend. The depth of recall will depend on the product’s degree of hazard and the extent of distribution. The levels are: consumer or user (may include doctors, hospitals), retail, and wholesale.

Deviation: Variation from a standard (i.e., SOP, approved policies, process instructions, etc.).

Discrepancy: Refers to result outside of an expected range or an unfulfilled requirement. Also may be called a nonconformity, defect, out-of-specification, or out-of-limit.

ECC: Engineering Change Control

ECN: Engineering Change Notification

ECO: Engineering Change Order

eCTD: Electronic Common Technical Document is an interface for the pharmaceutical industry to transfer regulatory information to the FDA.
The content is based on the Common Technical Document.

EDC: Engineering Drawing Control

eDHF: Electronic Design History File. Each manufacturer shall establish and maintain a DHF for each type of device.
The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part.

eDHR: Electronic Device history record (DHR) means a compilation of records containing the production history of a finished device.

EDI: Electronic Data Interchange (EDI) allows for the bulk submission of records, (i.e. insurance claims, etc.) to third party distributors, handlers or disseminators of records. AS2 (Applicability Statement 2), the required specifications for the electronic data interchange between businesses makes use of the Internet's  Hypertext Transfer Protocol (HTTP). The specification is an extension of the earlier version, Applicability Statement 1 (AS1).
Both specifications were created by EDI over the Internet (EDIINT), a working group of the Internet Engineering Task Force (IETF) that develops secure and reliable business communications standards.

The AS2 standard provides Secure Multi-Purpose Internet Mail Extensions (S/MIME) and uses HTTP or a more secure version, HTTPS, to transmit data over the Internet. AS1 uses a slower protocol, SMTP (Simple Mail Transfer Protocol). The use of HTTP or HTTPS allows communication in real time rather than through e-mail delivery. Security, authentication, message integrity, and privacy are assured by the use of encryption and digital signatures.

Another important feature, nonrepudiation, makes it impossible for the intended recipient of a message to deny having received it. The AS2 standard allows businesses to use a common, single communications solution. This transfer protocols, a Web server, an EDI transfer engine, and digital certificates are required for data exchange using AS2. Almost any type of data can
be transmitted.

eDMR: Electronic Device master record (DMR) means a compilation of records containing the procedures and specifications for a finished device.

Electronic Batch Record (EBR): Electronic Batch Records

EPRCA: Emergency Planning and Community and Right-to-Know Act Compliance Monitoring - Regulated by the EPA and applicable to specific chemical manufacturers

FMEA: Failure Mode Effects Analysis is a tool for evaluating potential failure modes for processes and their likely effect on outcomes and/or product performance.

Form FDA-483: A form that lists observations made by the FDA representative(s) during inspection of a facility. They are observations and don’t represent final agency determination.

FISMA: Federal Information Systems Management Act

FES: Functional Engineering Standards

EMEA: European Medicines Agency (Euro FDA)

EEC: European Economic Community

eIND: electronic-Investigational New Drug Application

Enterprise: MasterControl Enterprise, a part of the MasterControl integrated quality management suite, provides powerful filtering capability that allows individual business units to manage certain aspects of their processes independently.

ERP: Any software system designed to support and automate the business processes of medium and large businesses. This may include manufacturing, distribution, personnel, project management, payroll, and financials.

Spark Solutions: In-a-box solution package for specific industries

FDA: A federal agency in the Department of Health and Human Services established to regulate the release of new foods and health-related products.

FDA-CDRH: Center for Disease and Radiological Health (Biotech / Pharma / Biomedics)

FEA: Finite element analysis (FEA) is a computer simulation technique used in engineering analysis. It uses a numerical technique called the finite element method (FEM). There are many finite element software packages, both free and proprietary.

Field Assurance Department: Consumer-related interface between consumer and manufacturing organization to report complaints / concerns

FIFRA: The Federal Insecticide, Fungicide and Rodenticide Act Compliance Monitoring - Enforced by the EPA - applicable to specified chemical manufacturers

FMS: Functional Maintenance Standards

FMEA: Failure Modes and Effect Analysis

FOS: Functional Operating Standards

FQS: Functional Quality Standards

FSS: Functional Supplier Standards

FRS / FS: Functional Requirements Specification

FTS: Functional Testing Standards

GAISP: Generally Accepted Information Security Principles

GEP: Good Engineering Practice

GALP: Good Automated Laboratory Practices

GAMP: Good Automated Manufacturing Practice (GAMP) is a technical sub-committee of the International Society of Pharmaceutical Engineering (ISPE). The goal of the committee is to promote the understanding of the regulation and use of automated systems within the pharmaceutical industry. The GAMP committee organizes training seminars and publishes a series of Good Practice Guides for its members on several topics involved in drug manufacturing: Guide for Validation of Automated Systems in Pharmaceutical Manufacture; Calibration Management ; Global Information Systems ; IT Infrastructure Control and Compliance ; A Risk-Based Approach to Compliant Electronic Records and Signatures (Part 11) ; Validation of Laboratory Computerized Systems

GERM: Good Electronic Records Management

GISP: Good Information Systems Practice

GLBA: Gramm-Leach-Bliley Act (Financial Privacy)

GPEA: Government Paper Elimination Act

GVP: Good Validation Practice

GxP: Generic term including: GMP, GAMP, GCP, GLP - Good Manufacturing practices / Automated Manufacturing / Clinical / Laboratory

GCP: Good Clinical Practices; An international standard for the conduct, monitoring, and reporting of clinical trials to help ensure that the data and results reported are accurate, and the rights of the trial subjects are protected.

GMP: Good Manufacturing Practice. See CGMP above.

GTP: Good Tissue Practice refers to regulations pertaining to methods used in, and facilities used for manufacturing human cellular and tissue-based products. Although sometimes used interchangeably with Current Good Tissue Practice (CGTP), the latter specifically refers to the requirements in subparts C and D of 21 CFR part 1271. 

HCFA: The Health Care Financing Administration is an acting government entity that oversees the Medicare and Federal Medicaid programs. The HCFA also manages quality assurance for these programs.

HCT/P: Human cell, tissue, and cellular and tissue-based products.

HPV Chemicals: High Product Volume chemicals are those chemicals produced in large quantities by U.S. chemical manufacturers. HPV chemicals are or can be regulated by the EPA.

ICH: The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use brings together the regulatory authorities of Europe, Japan, and the United States, and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration.

IDE: Investigational Device Exemption; allows companies to sell and use a limited number of devices for investigational purposes and clinical studies.

IND: Investigational Drug Application; allows investigational drug to be used in clinical studies. It is synonymous with “Notice of Claimed Investigational Exemption for a New Drug.”

IFU: Documented directions for use or application of a product. Used as a resource by Medical Services Departments supporting professionals.

IND: A designation by the United States Food and Drug Administration for an experimental drug that has not yet been approved for marketing but can be transported within the United States across state lines. Pharmaceutical companies use the IND Review to petition the FDA to allow human research. Requirement to proceed with clinical research.

IND Review: Petition to FDA for human research

Informed consent: Informed consent is a legal condition whereby a person can be said to have given consent based upon an appreciation and understanding of the facts and implications of an action. The individual needs to be in possession of all of his faculties, such as not being mentally retarded or mentally ill and without an impairment of judgment at the time of consenting. Such impairments might include illness, intoxication, drunkenness, using drugs, insufficient sleep, and other health problems.

IP (1): Implementation Planning is part of the project management plan used by MasterControl. Customers meet with the Project Office to establish success criteria and agree on how to achieve it.

IP (2): Used in the Pharmaceutical area to discuss patents or patentability of a NCE or lab technique. This term is most often used to refer to the 'whole' body of knowledge. (i.e. all of the novel chemistry or biology discovered by a company which is patented or begin patented)

IP (3): Internet Protocol (IP) is a data-oriented protocol (format for transmitting data between two devices) used for communicating data across a packet-switched internetwork (communications paradigm in which packets (units of information carriage) are routed between nodes over data links shared with other traffic).

IP Address: An identifier for a computer or device on a TCP/IP network. Networks using the TCP/IP protocol route messages based on the IP address of the destination. The format of an IP address is a 32-bit numeric address written as four numbers separated by periods. Each number can be zero to 255. For example, could be an IP address.

IQ: IQ confirms that the software was installed successfully according to specifications for correct and reliable functioning.

IRB: The role of the IRB is to ensure the rights and welfare of the trial subjects by providing initial and ongoing review and approval (or disapproval) of clinical trials. An institutional review board/independent ethics committee (IRB/IEC) (also known as ethical review board) is a group that has been formally designated to review and monitor biomedical and behavioral research involving human subjects. In accordance with Food and Drug Administration (FDA) and HHS regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. An IRB performs critical oversight functions for research conducted on human subjects that are scientific, ethical, and regulatory. In the United States, IRBs are mandated by the Research Act of 1974, which defines IRBs and requires them for all research that receives funding, directly or indirectly, from what was the Department of Health, Education, and Welfare at the time, and is now the Department of Health and Human Services (HHS). IRBs are themselves regulated by the Office for Human Research Protections (OHRP) within HHS. IRBs were developed in direct response to research abuses earlier in the twentieth century.

ISO: An organization that sets standards in many businesses and technologies, including computing and communications.
ISO is a network of the national standards institutes of 157 countries, on the basis of one member per country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system. ISO is the world’s leading developer of International Standards.

  • ISO standards specify the requirements for state-of-the-art products, services, processes, materials and systems, and for good conformity assessment, managerial and organizational practice.
  • ISO standards are designed to be implemented worldwide.

ITGI: IT Governance Institute

ISACA: Information Systems Audit and Control Association

IEEE: Institute of Electrical and Electronics Engineers

HCFA: Centers for Medicare & Medicaid Services (CMS), previously known as the Health Care Financing Administration (HCFA), is a federal agency within the United States Department of Health and Human Services (DHHS) that administers the Medicare program and works in partnership with State governments to administer Medicaid, the State Children's Health Insurance Program (SCHIP), and health insurance portability standards. In addition to these programs, CMS has other responsibilities, including the administrative simplification standards from the Health Insurance Portability and Accountability Act of 1996 (HIPAA), quality standards in long-term care facilities (more commonly referred to as nursing homes) through its survey and certification process, and clinical laboratory quality standards under the Clinical Laboratory Improvement Amendments.

Healthcare Industry: ALSO CALLED: Computed Tomography, Health Care and Social Assistance Industry, Digital Radiography, Medical Laboratories, Hospital Industry, Healthcare Industry, Home Health Care Industry, Residential Care Facilities, Health Industry, Health Care Supplies Industry, Picture Archiving and Communications Systems, Medical and Diagnostic Laboratories, Medical Equipment Industry, MRI, PACS, Medical Devices Industry, Nursing Homes, Dental Offices, Diagnostic Imaging Equipment, Healthcare Products, Medical Offices, X-ray Mammography, Ultrasound Equipment, Home Healthcare Industry, Medical Devices, Long-Term Care Facilities, Health Care Facilities, Medical Industry, Specialized Health Care Services, Magnetic Resonance Imaging, Managed Care Organizations, Specialized Healthcare, Health Care Providers, Health Services, Medical Imaging Industry, Health Care Equipment Industry, Health Care Plans, HMOs, Physical Therapy, Health Care Services Industry, Healthcare Services Industry, Medical Research, Nursing Care Facilities, and Social Services

HIPAA: Health Insurance Portability and Accountability Act. DEFINITION: HIPAA is the United States Health Insurance Portability and Accountability Act of 1996. There are two sections to the Act. HIPAA Title I deals with protecting health insurance coverage for people who lose or change jobs. HIPAA Title II includes an administrative simplification section which deals with the standardization of healthcare-related information systems. In the information technology industries, this section is what most people mean when they refer to HIPAA.

HIPAA establishes mandatory regulations that require extensive changes to the way that health providers conduct business. HIPAA seeks to establish standardized mechanisms for electronic data interchange (EDI), security, and confidentiality of all healthcare-related data. The Act mandates: standardized formats for all patient health, administrative, and financial data; unique identifiers (ID numbers) for each healthcare entity, including individuals, employers, health plans and health care providers; and security mechanisms to ensure confidentiality and data integrity for any information that identifies an individual.

JETT: Joint Equipment Transition Team

JCAHO: Joint Commission standards address the organization’s level of performance in key functional areas, such as patient rights, patient treatment, and infection control. The standards focus not simply on an organization’s ability to provide safe, high quality care, but on its actual performance as well. Standards set forth performance expectations for activities that affect the safety and quality of patient care. The Joint Commission develops its standards in consultation with health care experts, providers, measurement experts, purchasers, and consumers.
The Joint Commission provides evaluation and accreditation services for the following types of organizations:

• General, psychiatric, children’s and rehabilitation hospitals
• Critical access hospitals
• Medical equipment services, hospice services and other home care organizations
• Nursing homes and other long term care facilities
• Behavioral health care organizations, addiction services
• Rehabilitation centers, group practices, office-based surgeries and other ambulatory care providers
• Independent or freestanding laboratories.

The Joint Commission also awards Disease Specific Care Certification to health plans, disease management service companies, hospitals and other care delivery settings that provide disease management and chronic care services. The Joint Commission also has a Health Care Staffing Services Certification Program and is developing a certification program for transplant centers and health care services.

LIMS: Laboratory Information Management System

Life Sciences: ALSO CALLED: Life Sciences, Biological Sciences, Medical Supplies Industry, Health Care Supplies Industry, Medical Equipment Industry, Medical Devices Industry, Natural Sciences, Medical Devices, Life Science Industry, Medical Device Industry, Medical Products Industry, Health Care Equipment Industry, and Medical Instruments Industry DEFINITION: Organizations in the fields of biotechnology, pharmaceuticals, biomedical technologies, life systems technologies, nutraceuticals, cosmeceuticals, food processing, environmental, biomedical devices.

Market Withdrawal: A firm’s removal or correction of a distributed product that involves a minor violation for which the FDA would not initiate a legal action (i.e., normal stock rotation practices, routine equipment adjustments and repair, product improvement).

Medical Device Reporting (MDR): CDRH monitors post-market medical device adverse reports through voluntary and mandatory reporting by manufacturers.

MedSun (Medical Device Surveillance Network): A medical device safety surveillance reporting program involving about 350 hospitals and nursing homes that had been trained to spot and report adverse events.

MedWatch: This is the FDA Safety Information and Adverse Event Reporting Program, which provides timely clinical information about safety issues involving medical products (drugs, biologics, medical devices, radiation-emitting devices, and special nutritional products). The program allows health-care professionals and the public to report serious problems associated with medical products.

MOTS: Modified/Modifiable Off The Shelf Software

MRPII: Manufacturing Resource Planning

Market Needs: Qualitative statements of the viability of marketing a product concept

MDM: Master Data Management (MDM), also known as Reference Data Management, is a discipline in Information Technology (IT) that focuses on the management of reference or master data that is shared by several disparate IT systems and groups. MDM is required to warrant consistent computing between diverse system architectures and business functions. Large companies often have IT systems that are used by diverse business functions (e.g., finance, sales, R&D, etc.) and span across multiple countries.These diverse systems usually need to share key data that is relevant to the parent company (e.g., products, customers, and suppliers). It is critical for the company to consistently use these shared data elements through various IT systems.

MDR: Medical Device Reporting (MedWatch - FDA safety information and adverse event reporting program)

Medical device: A medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: - recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, - intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes. as defined by the US FDA.

Medical Records Management: The planning, controlling, directing, organizing, training, promoting, and other managerial activities related to the creation, maintenance and use, and disposition of medical records to achieve adequate and proper documentation of a health care organization's policies and transactions.

Medical Services Department: Physician (medical professional)-related interface between physician and manufacturing organization to request information or report complaints / concerns.

MES: Manufacturing Execution Systems – software to manage plant floor execution.

MRP: Material Requirements Planning application (MRP) A system for effectively managing material requirements in a manufacturing process.
According to the American Production and Inventory Control Society, Inc. (APICS), MRP is a set of techniques that uses bill of material data, inventory data, and the master production schedule to calculate requirements for materials. It makes recommendations to reorder materials. Furthermore, because it is time-phased, it makes recommendations to reschedule open orders when due dates and need dates are not in phase. Time-phased MRP begins with the items listed on the Master Production Schedule and determines the quantity of all components and materials required to fabricate those items and the date that the components and material are required. Time-phased MRP is accomplished by exploding the bill of material, adjusting for inventory quantities on hand or on order and offsetting the net requirements by the appropriate lead times.

New Chemical Entities: In the early stages of research, a new substance that has never been used in humans and has been tested only in animals is called new chemical entity.

NDA: New Drug Application must contain data for review, including chemistry, pharmacology, medical, biopharmaceutics, and statistics.
If the NDA is approved, the product may be marketed in the United States. 

New Molecular Entity: A previously unknown, undescribed or unpublished chemical entity. The FDA uses NME and measures the 'new' or 'novel' status against the previously approved or known medicines. The scientific community most often uses the NCE term and uses published literature as the measure of 'new' or 'novel' status.

Nonconforming product: FDA 21 CFR Part 802: Subpart I--Nonconforming Product Sec. 820.90 Nonconforming product.

(a) Control of nonconforming product. Each manufacturer shall establish and maintain procedures to control product that does not conform to specified requirements. The procedures shall address the identification, documentation, evaluation, segregation, and disposition of nonconforming product. The evaluation of nonconformance shall include a determination of the need for an investigation and notification of the persons or organizations responsible for the nonconformance. The evaluation and any investigation shall be documented.

(b) Nonconformity review and disposition.

(1) Each manufacturer shall establish and maintain procedures that define the responsibility for review and the authority for the disposition of nonconforming product. The procedures shall set forth the review and disposition process. Disposition of nonconforming product shall be documented. Documentation shall include the justification for use of nonconforming product and the signature of the individual(s) authorizing the use.

(2) Each manufacturer shall establish and maintain procedures for rework, to include retesting and reevaluation of the nonconforming product after rework, to ensure that the product meets its current approved specifications. Rework and reevaluation activities, including a determination of any adverse effect from the rework upon the product, shall be documented in the DHR.

Nonrepudiation (See EDI): DEFINITION: In general, nonrepudiation is the ability to ensure that a party to a contract or a communication cannot deny the authenticity of their signature on a document or the sending of a message that they originated. On the Internet, the digital signature is used not only to ensure that a message or document has been electronically signed by the person that purported to sign the document, but also, since a digital signature can only be created by one person, to ensure that a person cannot later deny that they furnished the signature. Since no security technology is absolutely fool-proof, some experts warn that the digital signature alone may not always guarantee nonrepudiation. It is suggested that multiple approaches be used, such as capturing unique biometric information and other data about the sender or signer that collectively would be difficult to repudiate.

Novel Chemical Entity: A previously unknown, undescribed or unpublished chemical entity. The FDA uses NME and measures the 'new' or 'novel' status against the previously approved or known medicines. The scientific community most often uses the NCE term and uses published literature as the measure of 'new' or 'novel' status.

Nonconformity: A deficiency in a characteristic, product specification, process parameter, record, or procedure that renders the quality of a product unacceptable, indeterminate, or not according to specified requirements.

NOTS: NASA or Niche Off The Shelf

NOC: Notice of Change

NCMR (Non-Conforming Material Report): A report that presents information regarding defective parts or materials.

NCTR: National Center for Toxicological Research

OC: Office of the Commissioner

OECD: Organization for Economic Cooperation and Development

OEM: (pronounced as separate letters) Short for original equipment manufacturer, which is a misleading term for a company that has a special relationship with computer producers. OEMs are manufacturers who resell another company's product under their own name and branding. While an OEM is similar to a VAR (value-added reseller), it refers specifically to the act of a company rebranding a product to its own name and offering its own warranty, support and licensing of the product. The term is really a misnomer because OEMs are not the original manufacturers; they are the customizers.

OPPT: The Office of Pollution Prevention and Toxics - One of the offices of the EPA (Environmental Protection Agency)

OoS: Out of Spec

ORA: Office of Regulatory Affairs

OQ: OQ involves the thorough verification and documentation that each function of the software operates as designed according to the requirements and/or specifications.

OSHA: OSHA's mission is to assure the safety and health of America's workers by setting and enforcing standards; providing training, outreach, and education; establishing partnerships; and encouraging continual improvement in workplace safety and health.

ONDC: The Office of New Drug Chemistry is now referred to as ONDQA or the Office of New Drug Quality Assessment.

ONDQA: The Office of New Drug Quality Assessment serves the public via the CDER and FDA organizations. The organization's main responsibilities include performing assessments of drug related quality attributes, performing assessments of drug related manufacturing processes, participating in the establishment of quality standards and in facilitating the developments of new drugs.

PAPC: Production and Production Control (Activities)

PCAOB: Public Company Accounting Oversight Board

Patent: A patent is a set of exclusive rights granted by a state to a patentee (the inventor or assignee) for a fixed period of time in exchange for the regulated, public disclosure of certain details of a device, method, process or composition of matter (substance) (known as an invention) which is new, inventive, and useful or industrially applicable. The exclusive right granted to a patentee in most countries is the right to prevent or exclude others from making, using, selling, offering to sell or importing the claimed invention. The rights given to the patentee do not include the right to make, use, or sell the invention themselves. The patentee may have to comply with other laws and regulations to make use of the claimed invention. So, for example, a pharmaceutical company may obtain a patent on a new drug but will be unable to market the drug without regulatory approval, or an inventor may patent an improvement to a particular type of laser, but be unable to make or sell the new design without a license from the owner of an earlier broader patent covering lasers of that type.

PDA: Parent Drugs Association

PhRMA: Pharmaceutical Research and Manufacturers of America

PDM: Product Data Management - The management and classification of design data and specifications for an engineered product, and the management of change to this information.

Pharmaceutical Industry: This industry comprises establishments primarily engaged in one or more of the following:

(1) manufacturing biological and medicinal products;
(2) processing (i.e., grading, grinding, and milling) botanical drugs and herbs;
(3) isolating active medicinal principals from botanical drugs and herbs; and
(4) manufacturing pharmaceutical products intended for internal and external consumption in such forms as ampoules, tablets, capsules, vials, ointments, powders, solutions, and suspensions.

PLC: Product Lifecycle

Phase I: Phase I trials are the first-stage of testing in human subjects. Normally a small (20-80) group of healthy volunteers will be selected. This phase includes trials designed to assess the safety (Pharmacovigilance), tolerability, pharmacokinetics, and pharmacodynamics of a therapy. Phase I trials also normally include dose-ranging studies so that doses for clinical use can be refined. Phase I trials most often include healthy volunteers, however there are some circumstances when patients are used, such as with oncology (cancer) and HIV drug trials. In Phase I trials of new cancer drugs, for example, patients with advanced (metastatic) cancer are used. There are two specific kinds of Phase I trials - SAD - Single Ascending Dose studies and MAD - Multiple Ascending Dose studies.

Phase II: Once the initial safety of the therapy has been confirmed in Phase I trials, Phase II trials are performed on larger groups (20-300) and are designed to assess clinical efficacy of the therapy; as well as to continue Phase I assessments in a larger group of volunteers and patients. The development process for a new drug commonly fails during Phase II trials due to the discovery of poor efficacy or toxic effects. Phase II studies are sometimes divided into Phase IIA and Phase IIB. Phase IIA is specifically designed to assess dosing requirements, whereas Phase IIB is specifically designed to study efficacy.
Some trials combine Phase I and Phase II into a single trial, monitoring both efficacy and toxicity.

Phase III: Phase III studies are randomized controlled trials on large patient groups (300–3,000 or more depending upon the condition) and are aimed at being the definitive assessment of the efficacy of the new therapy, in comparison with current 'Gold Standard' treatment. Phase III trials are the most expensive, time-consuming and difficult trials to design and run; especially in therapies for chronic conditions. Once a drug has proven satisfactory over Phase III trials, the trial results are usually combined into a large document containing a comprehensive description of the methods and results of human and animal studies, manufacturing procedures, formulation details, and shelf life. This collection of information makes up the "regulatory submission" that is provided for review to various regulatory authorities in different countries, such as the Therapeutic Goods Administration (TGA) in Australia, the European Medicines Agency (EMEA) or the Food and Drug Administration (FDA) in the United States for marketing approval. It is also common practice with many drugs whose approval is pending, that certain phase III trials will continue in an attempt at "label expansion”. In other words, proving additional efficacy for uses beyond the original use for which the drug was designed. Other reasons for performing trials at this stage are to support marketing claims. Studies in this phase are by some companies categorised as"Phase IIIB studies"

Phase IV: Phase IV trials involve the post-launch safety surveillance and ongoing technical support of a drug. Phase IV studies may be mandated by regulatory authorities or may be undertaken by the sponsoring company for competitive or other reasons. Post-launch safety surveillance is designed to detect any rare or long-term adverse effects over a much larger patient population and timescale than was possible during the initial clinical trials. Such adverse effects detected by Phase IV trials may result in the withdrawal or restriction of a drug - recent examples include cerivastatin (brand names Baycol and Lipobay), troglitazone (Rezulin) and rofecoxib (Vioxx).

Pipeline: concepts / plans in progress for product development or projects

Placebo: A placebo is a medicine or preparation which has no inherent pertinent pharmacologic activity but which is effective only by virtue of the factor of suggestion attendant upon its administration. The substance may be ingested, injected, inserted, inhaled or applied

PLM: Product lifecycle management (PLM) is the process of managing the entire lifecycle of a product from its conception, through design and manufacture, to service and disposal. It is one of the four cornerstones of a corporation's information technology structure. All companies need to manage communications and information with their customers (CRM-Customer Relationship Management) and their suppliers (SCM-Supply Chain Management) and the resources within the enterprise (ERP-Enterprise Resource Planning). In addition, manufacturing engineering companies must also develop, describe, manage and communicate information about their products (PLM).

PMA: Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Due to the level of risk associated with Class III devices, FDA has determined that general and special controls alone are insufficient to assure the safety and effectiveness of class III devices. Therefore, these devices require a premarket approval (PMA) application under section 515 of the FD&C Act in order to obtain marketing clearance. Please note that some Class III preamendment devices may require a Class III 510(k). See "Historical Background" below for additional information. PMA is the most stringent type of device marketing application required by FDA. The applicant must receive FDA approval of its PMA application prior to marketing the device. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s). An approved PMA is, in effect, a private license granting the applicant (or owner) permission to market the device. The PMA owner, however, can authorize use of its data by another.

PQ: PQ shows that the software, instrument, or equipment operates properly in the customer’s environment using the customer’s SOPs, Training, Instruments, Methodologies etc.  Typically, Customers perform PQ for themselves.

PQ Accelerator: Template for creating PQ Scripts

Process Controls: FDA - 21 CFR Part 820 Subpart G--Production and Process Controls Sec. 820.70 Production and process controls.

(a) General. Each manufacturer shall develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications.

Where deviations from device specifications could occur as a result of the manufacturing process, the manufacturer shall establish and maintain process control procedures that describe any process controls necessary to ensure conformance to specifications.
Where process controls are needed they shall include:

(1) Documented instructions, standard operating procedures (SOP's), and methods that define and control the manner of production;
(2) Monitoring and control of process parameters and component and device characteristics during production;
(3) Compliance with specified reference standards or codes;
(4) The approval of processes and process equipment; and
(5) Criteria for workmanship which shall be expressed in documented standards or by means of identified and approved representative samples.

Process Validation: FDA - 21 CFR Part 820 Subpart G Sec. 820.75 Process validation.

(a) Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures. The validation activities and results, including the date and signature of the individual(s) approving the validation and where appropriate the major equipment validated, shall be documented.
(b) Each manufacturer shall establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met.
(1) Each manufacturer shall ensure that validated processes are performed by qualified individual(s).
(2) For validated processes, the monitoring and control methods and data, the date performed, and, where appropriate, the individual(s) performing the process or the major equipment used shall be documented.
(c) When changes or process deviations occur, the manufacturer shall review and evaluate the process and perform revalidation where appropriate.
These activities shall be documented.

PDUFA: The Prescription Drug User Fee Act is the first of a series of laws that allow the FDA to help fund the review of new drugs through fees paid by pharmaceutical companies. PDUFA was first enacted in 1992, and has been reauthorized twice, each time for five years, in 1997 and 2002.

PMN: Pre-manufacture Notice - the report that chemical manufacturers or chemical importers must create who want to process, produce, develop or import a new chemical that has not been listed on the TSCA Chemical Substance Inventory.

Pre-market Notification: Also known as 510 (k). For medical device manufacturers, there are three types of 510(k) they can submit depending on their product: traditional, special, and abbreviated.

Predicate Rule: A predicate rule is any FDA regulation that requires companies to maintain certain records and submit information to the agency as part of compliance." (Source:

QC: Quality control (QC) assesses, in real time, whether the performance of an individual unit is sufficiently similar to their previous performance for results to be used; it controls reproducibility or precision. Most QC procedures employ analysis of a control material and compare the result with predetermined limits of acceptability unsatisfactory sets of results may thereby be suppressed.

QMS: A quality management system (QMS) is a system that outlines the policies and procedures necessary to improve and control the various processes that will ultimately lead to improved business performance

QSIP: Quality System Inspection for Pharmaceuticals

QSIT: Quality System Inspection Technique

QSR: Quality System Records/Regulation

Quality Audit: FDA 21 CFR Part 820 Sec. 820.22 Quality audit.
Each manufacturer shall establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system. Quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited. Corrective action(s), including a reaudit of deficient matters, shall be taken when necessary. A report of the results of each quality audit, and reaudit(s) where taken, shall be made and such reports shall be reviewed by management having responsibility for the matters audited. The dates and results of quality audits and reaudits shall be documented.

Quality Management Representative: Management representative. Management with executive responsibility shall appoint, and document such appointment of, a member of management who, irrespective of other responsibilities, shall have established authority over and responsibility for:

(i) Ensuring that quality system requirements are effectively established and effectively maintained in accordance with this part; and
(ii) Reporting on the performance of the quality system to management with executive responsibility for review.

Quality Management Review: Management review. Management with executive responsibility shall review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the manufacturer's established quality policy and objectives.
The dates and results of quality system reviews shall be documented.

Quality Plan: Each manufacturer shall establish a quality plan which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured. The manufacturer shall establish how the requirements for quality will be met

Quality Policy: Quality policy. Management with executive responsibility shall establish its policy and objectives for, and commitment to, quality.
Management with executive responsibility shall ensure that the quality policy is understood, implemented, and maintained at all levels of the organization.

Quality System Records: Quality system procedures. Each manufacturer shall establish quality system procedures and instructions. An outline of the structure of the documentation used in the quality system shall be established where appropriate.

Quality Control: Steps taken during the making of a product/service to ensure that it meets requirements and that the product/service is reproducible.

Quality Management: Overall accountability for the successful implementation of the quality system.

Quality System: Formalized business practices that define management responsibilities for organizational structure, processes, procedures, and resources needed to fulfill product/service requirements, customer satisfaction, and continual improvement.

QSIT: Quality System Inspection Technique is a process used by FDA field staff for inspecting medical device manufacturers’ compliance with the Quality System Regulation (21 CFR 820) and related regulations. It is designed as a top-down approach to help FDA investigators focus on key elements of a firm’s quality system.

QSR: Quality System Regulation - Section 520 of the FD&C Act requires that domestic and foreign manufacturers have a quality system for the design and production of medical devices intended for commercial distribution in the United States. Quality System regulation helps assure that medical devices are safe and effective for their intended use.

Record Retention: FDA 21 CFR Part 820 Subpart M--Records Sec. 820.180 General requirements.
All records required by this part shall be maintained at the manufacturing establishment or other location that is reasonably accessible to responsible officials of the manufacturer and to employees of FDA designated to perform inspections. Such records, including those not stored at the inspected establishment, shall be made readily available for review and copying by FDA employee(s). Such records shall be legible and shall be stored to minimize deterioration and to prevent loss. Those records stored in automated data processing systems shall be backed up. (a) Confidentiality. Records deemed confidential by the manufacturer may be marked to aid FDA in determining whether information may be disclosed under the public information regulation in part 20 of this chapter.
(b) Record retention period. All records required by this part shall be retained for a period of time equivalent to the design and expected life of the device, but in no case less than 2 years from the date of release for commercial distribution by the manufacturer.

RCRA: Resources Conservation and Recovery Act - Regulated by the EPA - Applicable to specified chemical manufacturers.

RFID: Radio Frequency Identification (RFID) is an automatic identification method, relying on storing and remotely retrieving data using devices called RFID tags or transponders. An RFID tag is an object that can be attached to or incorporated into a product, animal, or person for the purpose of identification using radio waves. Chip-based RFID tags contain silicon chips and antennae. Passive tags require no internal power source, whereas active tags require a power source.

Risk Analysis: Risk analysis = risk assessment + risk management + risk communication.

Risk assessment: Involves identifying sources of potential harm, assessing the likelihood that harm will occur and the consequences if harm does occur.

Risk management: Evaluates which risks identified in the risk assessment process require management and selects and implements the plans or actions that are required to ensure that those risks are controlled. Risk communication : involves an interactive dialogue between stakeholders and risk assessors and risk managers which actively informs the other processes.

Risk Management: ALSO CALLED: Managing Risk, Enterprise Risk Management, Loss Management, Business Risk Analysis, and IT Risk Management
DEFINITION: Enterprise risk management (ERM) is the process of planning, organizing, leading, and controlling the activities of an organization in order to minimize the effects of risk on an organization's capital and earnings. Enterprise risk management expands the process to include not just risks associated with accidental losses, but also financial, strategic, operational, and other risks. In recent years, external factors have fueled a heightened interest by organizations in ERM. Industry and government regulatory bodies, as well as investors, have begun to scrutinize companies' risk-management policies and procedures.
In an increasing number of industries, boards of directors are required to review and report on the adequacy of risk-management processes in the organizations they administer. Since they thrive on the business of risk, financial institutions are good examples of companies that can benefit from effective ERM.
Their success depends on striking a balance between enhancing profits and managing risk. Business risk management, holistic risk management, and strategic risk management are synonyms.

RMA: A Return Merchandise Authorization or Return Material Authorization (RMA) is a transaction whereby the recipient of a product arranges to return defective goods to the supplier to have the product repaired or replaced or in order to receive a refund or credit for another product from the same retailer or corporation.

Recall: A firm’s removal or correction of a marketed product that the FDA considers to be in violation of FDA regulations and which the agency would initiate an action (seizure).

Recall Classification: A numerical designation assigned by the FDA to a product recall to indicate the degree of health hazard.
Class I means there’s a strong likelihood that use of, or exposure to, the product in violation will cause serious adverse health consequences or death.
Class II means the use of, or exposure to, the product may cause temporary or medically reversible adverse health consequences.
Class III means the use of, or exposure to, the product is not likely to cause adverse health consequences.

Review: The basis of FDA’s decision to approve an application. It includes a comprehensive analysis of clinical trial data and other information.

Risk Assessment: A systematic evaluation of the risk of a process by determining what can go wrong (risk identification), how likely it is to occur (risk estimation), and what the consequences are.

Risk Management: The process of identifying, evaluating, selecting, and implementing actions to reduce risk to human health and ecosystems.

SDS / SDD: Software Design Specification/Document

SOP: Standard Operating Procedures

Solution Packages : MasterControl CAPA™ system interconnects different quality subsystems and tracks incidents that can escalate into a corrective action.
It includes a best-practice “8D” process to guide the quality team through every step of CAPA implementation, from identification of the problem through corrective action.
MasterControl Change Control™ streamlines the entire change control procedure for faster turnaround.
MasterControl Nonconformance™ is a robust solution designed to automate, manage, and streamline the process for identifying, evaluating, reviewing, and handling of nonconforming materials, components, parts, and finished products.
MasterControl Audit™ automates, streamlines, and effectively manages the audit process.
MasterControl Customer Complaints™ streamlines the complaint-handling process and reduces the lifecycle from submission to resolution.
MasterControl SOX™, for companies seeking compliance with the Sarbanes-Oxley Act, is a complete and easy-to-use solution that automates and effectively manages business processes, including voluminous documents, records, and SOPs.

SOX: Sarbanes/Oxley

SQA: Society of Quality Assurance

TDS: Technical Design Specification

Submissions: Collection of data and study results provided to FDA to obtain approval to manufacture and sell a product
MasterControl Submissions Gateway™ facilitates electronic delivery of FDA applications (such as IND , NDA, and BLA) by providing control in assembling and tracking necessary documentation. It provides appropriate templates to streamline the dossier-creation process. MasterControl can be integrated with leading e-submission applications, connecting approved documents and forms-based content with the dossier assembly process, to accelerate submissions.

Synthesis & Purification: This stage focuses on refining the novel chemical entity and subsequent formulation.
Application of Animal Pharmacology and Toxicology provide data as to successful outcomes and safety of the new product.

Safety: Safety of a drug is determined by the FDA case by case and reflects the relationship between the drug’s risks versus its benefits.

SNDA: Supplemental New Drug Application. The off-label uses of a drug may become additional on-label uses if the company submits an SNDA and the FDA approves it.

URS: User Requirements Specification

TOQ: Validation of software conducted on hardware / software configuration housed at MasterControl; validation certificate provided along with Risk Assessment for specific client installation;often used for ASP service option

TSCA: Toxic Substances Control Act - Enforced by the EPA (Environmental Protection Agency) - Allows EPA the authority to require data devleopment including chemicals testing for and in behalf of gathering greater knowledge of those chemicals with the purpose of a better understanding of health and environmental issues.

TSCA Chemical Substance Inventory: Toxic Substances Control Act Chemical Substance Inventory - An inventory of all chemicals processed or manufactured in the U.S. The authority for this collection of data originates in the TSCA (section 8b).

Traceability: FDA 21 CFR Part 820 Subpart F--Identification and Traceability Sec. 820.60 Identification.
Each manufacturer shall establish and maintain procedures for identifying product during all stages of receipt, production, distribution, and installation to prevent mixups.
Sec. 820.65 Traceability.
Each manufacturer of a device that is intended for surgical implant into the body or to support or sustain life and whose failure to perform when properly used in accordance with instructions for use provided in the labeling can be reasonably expected to result in a significant injury to the user shall establish and maintain procedures for identifying with a control number each unit, lot, or batch of finished devices and where appropriate components. The procedures shall facilitate corrective action. Such identification shall be documented in the DHR.

VC: Validation Committee

White Paper: A white paper is an authoritative report; a government report outlining policy; or a document for the purpose of educating industry customers or collecting leads for a company. White papers are used to help people make decisions.

WHO: World Health Organization

Work Instructions:
A set of step-by-step instructions distributed to shop-floor workstations and production assembly lines that describes the operations and rules needed to assemble parts.
WIs are generally presented as a multilevel, hierarchical/structured list where each level can include text, technical drawings, and assembly
The complexity of the WI is determined by several factors: number of products and people involved, plants, range, parts,
processes, and manufacturing operations.
The efficiency of WI systems and processes has a direct and significant impact on enterprise business

VAERS: The Vaccine Adverse Event Reporting System is for reporting adverse events or side effects related to the administration of a vaccine.

Warning Letter: An enforcement letter written by a senior-level FDA official to top management of a manufacturer to point out violations that need prompt correction. The letter contains a formal warning that unless corrective action is taken, the FDA is prepared to impose legal and/or administrative sanctions (i.e., seizure, prosecution, injunction, civil penalties).