MasterControl Products

Integrated Business Process Management Software

With more than a decade of experience in the rigorous FDA and ISO environments, MasterControl has developed an integrated software solution that combines industry best practices with the flexibility to meet every customer's unique needs.

The MasterControl™ GxP process management suite consists of configurable, easy-to-use, and connected applications for automating, streamlining, and effectively managing GxP processes throughout the entire product development process from conception to commercialization. Hundreds of companies worldwide rely on MasterControl to facilitate compliance with FDA, and other worldwide regulatory bodies (e.g., GxPs, 21 CFR Parts 11, 210-211, 820, 606), and ISO quality standards (e.g., ISO 9000, ISO 13485, ISO 14000, ISO/TS16949) to improve product quality and safety - and to ensure compliance.

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MasterControl Applications:

MasterControl Audit
MasterControl Bill of Materials
MasterControl Documents
MasterControl GLP Studies
MasterControl Process
MasterControl QMS Suite Overview
MasterControl Risk
MasterControl Spark
MasterControl Supplier
MasterControl Training

MasterControl Core Add-ons:

MasterControl Analytics
MasterControl Collaboration
MasterControl Exams
MasterControl Guest Connect
MasterControl Languages
MasterControl Mobile
MasterControl PDF Publishing
MasterControl Projects

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MasterControl Business Processes:

MasterControl Accident/Injury
MasterControl Business Process Library
MasterControl CAPA
MasterControl Clinical CAPA
MasterControl Clinical Protocol Deviation Management
MasterControl Clinical Site Closeout Monitoring
MasterControl Clinical Site Initiation Monitoring
MasterControl Clinical Site Interim Monitoring
MasterControl Customer Complaints
MasterControl Deviations
MasterControl Electronic Batch Records
MasterControl eMDR
MasterControl Equipment Calibration
MasterControl Equipment Maintenance
MasterControl HR Finance
MasterControl Incident Reporting
MasterControl Meeting Notes
MasterControl Nonconformance
MasterControl Out of Specification
MasterControl Risk Analysis
MasterControl Supplier Corrective Action (SCAR)
MasterControl Supplier Deviation
MasterControl Supplier Scorecard
MasterControl Variance

MasterControl Connectors and Integrations

To review MasterControl's integration options with other software solutions, Click Here.

MasterControl Industry-Specific Solutions

To explore MasterControl's additional software solutions focused on particular industries, Click Here.

MasterControl Applications:

MasterControl Audit™

MasterControl Audit enables companies to better manage their entire audit process — from planning audits and capturing findings to conducting CAPAs and creating final audit reports. The solution connects the audit process with the rest of the quality system for a comprehensive approach to quality management.

MasterControl Bill of Materials™

MasterControl Bill of Materials streamlines the handling of BOMs and helps companies overcome common BOM-related predicaments.

MasterControl Documents™

MasterControl Documents helps increase the quality unit's efficiency and effectiveness by automating task assignment/routing, scheduling, follow-up, tracking, escalation, review, and approval of all documents-based processes. It provides a single repository for all documentation, making search and retrieval easy. MasterControl Documents, the core application in the MasterControl quality management suite, integrates all quality processes such as change control, customer complaints, corrective/preventive action, audits, etc., for a closed-loop solution.

MasterControl GLP Studies™

MasterControl Studies enables companies in FDA environments to better manage quality information related to their GLP and GCP studies. The solution adds a number of key features to MasterControl's already-robust functionality, including: management of studies; study aspects, phases and protocols; analytics reporting; and more.

MasterControl Process™

MasterControl Process automates routing, notification, escalation, and approval of any forms-based process for faster turnaround. This solution offers best-practice features that prompt users with selected data to reduce data entry and avoid mistakes common in manual data entry. Forms created in Microsoft Word, Excel, or PowerPoint can be converted to PDF as is, so users will see the same form and won't need new training. A company may also improve existing forms or design new ones to suit its needs.

MasterControl Risk™

MasterControl Risk unifies all risk-related activities and documentation in a single, centralized repository, providing an accurate picture of the risk landscape across product lines, business processes and business units. The solution's robust features provide insight into, and easy access to, risk assessment and mitigation activities.

MasterControl QMS Suite Overview™

The MasterControl quality management software (QMS) suite offers regulated organizations of all sizes the most complete choice of integrated quality and compliance solutions. Built on a centralized Web-based platform, the suite consists of configurable, easy-to-use applications that automate, streamline and connect all quality processes for a holistic approach to quality management.

MasterControl Spark™

MasterControl Spark is a hosted product package specifically designed to meet the unique needs of small, growing regulated businesses — delivering the same world-class MasterControl software used by enterprise-size organizations but at a lower cost. Spark requires minimal IT resources and comes complete with an education, services and implementation offering.

MasterControl Supplier™

MasterControl Supplier provides a solution for collecting, organizing, and reviewing all the documents required to meet the GCP requirements.

MasterControl Training™

MasterControl Training automates assignment and monitoring of training tasks and grading of online exams. It allows sequencing of training courses, so after a prerequisite course is completed, the next one is automatically launched. Provides group sign-off feature for verifying training of large groups of employees. Training management can be integrated with the rest of the quality system, so any change to a document or process that warrants new training will automatically invoke training tasks upon approval of the change.

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MasterControl Core Add-Ons:

Click Here to View Entire Add-Ons List

MasterControl Analytics™

MasterControl Analytics is an easy-to-use software application that enables non-technical users to develop sophisticated, customized reports. It provides a practical alternative to creating reports manually.

MasterControl Collaboration™

MasterControl Collaboration helps companies maximize their intellectual assets by automating, simplifying, and optimizing the process of collaboration in documents-based projects.

MasterControl Exams™

MasterControl Exams is an optional upgrade to MasterControl Training that helps automate the administering and grading of exams, as well as documenting employee competencies.

MasterControl Guest Connect™

MasterControl Guest Connect enables companies to connect trusted outside parties to a secure online collaboration space. Customers can give practical interaction capabilities to suppliers, partners or consultants early in a development cycle without giving them a full-access account.

MasterControl Languages™

MasterControl Languages allows MasterControl solutions to be operated in the following languages: Chinese; English; French; German; Italian; Japanese; Korean; and Spanish. MasterControl's language translation functionality increases users' comfort level, communication and effectiveness with the quality system.

MasterControl Mobile™

MasterControl Mobile enables users to access critical documents, tasks and information remotely with just a smart phone or tablet and an internet connection. MasterControl Mobile can be used in the office, on the shop floor, in the lab, on the road, down the hall and across the globe.

MasterControl PDF Publishing™

MasterControl PDF Publishing provides automated PDF publishing of document. The product helps preserve record authenticity and improve regulatory and quality compliance by restricting user rights like open, copy, paste or other PDF options.

MasterControl Projects™

MasterControl Projects automates the process of controlling projects, particularly those that are document and/or process-based. It automates task assignment, routing, escalation, and tracking. It streamlines the workflow and provides project transparency that fosters accountability.

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MasterControl Business Processes:

MasterControl Accident/Injury™

The MasterControl Accident/Injury solution has been specifically designed to help companies comply with OSHA Regulation 1904 and also manage accident and injury reporting more effectively and efficiently. It is a comprehensive solution for any organization, regardless of existing in-house capabilities, and can be packaged with the particular level of service and support the organization requires.

MasterControl Business Process Library™

MasterControl Business Process Library MasterControl offers Business Process Library subscriptions that allow companies to pick and choose suitable solutions according to their specific needs.

MasterControl CAPA™

The 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. A CAPA form can be launched directly from another form (e.g., nonconformance or deviation report), automatically entering relevant data into the CAPA form, reducing data entry and eliminating errors from manual transfer of information. Through the Internet, customers, vendors, and others outside the company can submit customer complaint or other forms that could lead to CAPA.

MasterControl Clinical CAPA™

MasterControl Clinical CAPA guides clinical quality teams through a formal review process for quality issues, which helps organizations manage CAPAs with greater proficiency. The solution simplifies document approvals, investigations into root cause, and documentation of actions taken.

MasterControl Clinical Protocol Deviation Management™

MasterControl's Clinical Protocol Deviation Management solution provides an electronic process form that assists the responsible clinical team member to identify a deviation, enter details, access the impact, track and trend, and determine if a follow-up corrective and/or preventative action (CAPA) must be taken.

MasterControl Clinical Site Closeout Monitoring™

MasterControl's Clinical Site Closeout Monitoring solution ensures that all open actions are completed, all information is reported to appropriate regulatory bodies, all data is complete and collected, and all investigational product is accounted for.

MasterControl Clinical Site Initiation Monitoring™

MasterControl Clinical Site Initiation Monitoring provides an electronic process form for visits by regulatory investigators/auditors, and allows for the effective capture of relevant information, launching of action tasks, and links to supporting study documentation.

MasterControl Clinical Site Interim Monitoring™

MasterControl Clinical Site Interim Monitoring provides a best-practices electronic process form that assists monitors in identifying the areas of focus based on risk, and helps them effectively capture information, launch action tasks, and link to support documentation.

MasterControl Change Control™

MasterControl Change Control streamlines the entire change control procedure for faster turnaround. It offers a best-practice form that incorporates priority level and prompts risk assessment and classification of the change as low, medium, or high. Any high-level change implies great impact on the product and is likely to require regulatory filing. Customizable reports provide real-time status not only of change control tasks but of the entire quality system.

MasterControl Customer Complaints™

MasterControl Customer Complaints streamlines the complaint-handling process and reduces the lifecycle from submission to resolution. A simple, three-step process is incorporated in a pre-configured, multi-page form that starts with the processing of a customer complaint, automatically moving to internal investigation, and culminating with a resolution of the issue. MasterControl's advanced reporting capabilities increase management oversight and demonstrate appropriate controls to regulatory agencies. MasterControl is Web-based, so customers can submit complaints from virtually anywhere.

MasterControl Deviations™

MasterControl Deviations automates and manages the process of documenting, investigating, and resolving operational deviations from written procedures and specifications. This solution provides the capability to resolve a deviation efficiently and to use data collected as a basis for continuous quality improvement.

MasterControl Electronic Batch Records™

MasterControl Electronic Batch Records, designed based on the Instrumentation, Systems and Automation Society's S88 model (ISA-S88 or S88), is a powerful EBR management solution for automating and controlling batch processes.

MasterControl eMDR™

MasterControl eMDR has been designed to meet the requirements for forms processes within the confines of FDA/GxP environments including compliance with 21 CFR Part 11.

MasterControl Equipment Calibration™

MasterControl Calibration is a configurable and easy-to-use solution designed to automate and manage the process of Inspecting and documenting the Calibration process.

MasterControl Equipment Maintenance™

MasterControl Equipment Maintenance is a configurable and easy-to-use solution designed to automate and manage routine and non-routine maintenance and inspection of equipment.

MasterControl HR Finance™

MasterControl HR Finance helps automate the administrative processes that bottleneck the flow and timely completion of essential HR and finance tasks.

MasterControl Incident Reporting™

MasterControl Incident Reporting serves as a pre-screen of quality issues, promoting only valid issues to quality events when necessary. The solution helps resolve major incident reporting challenges related to nonconformances, deviations, variances, customer complaints and other quality events.

MasterControl Meeting Notes™

The MasterControl Meeting Notes solution serves as an aid in managing meetings of any kind by supplying "Action Items" that will automatically track assigned tasks that must be completed as a result of a meeting's developments and results. It can improve the productivity of an organization's meetings by providing a centrally-accessible repository for meeting minutes and automating follow-up on action items.

MasterControl Nonconformance™

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. The solution's best-practice form and five-step process connect all responsible personnel for effective and timely disposition of a nonconformance. This solution offers the choice of maintaining a stand-alone nonconformance process for small-scale, localized incidents, or you may connect it to the CAPA process for automatic escalation when the situation warrants it. Training will automatically invoke training tasks upon approval of the change.

MasterControl Out of Specification™

MasterControl Out-of-Specification is a configurable and easy-to-use solution designed to automate and manage the out-of-specification process, including investigation of laboratory test results, investigation of production records, corrective action and batch disposition.

MasterControl Risk Analysis™

MasterControl Risk Analysis establishes risk evaluation as a separate process. The output is a risk score based on a consistent process, which enables quality departments to reduce the oftentimes subjective nature of quality decision making.

MasterControl Supplier Corrective Action Request (SCAR)™

The MasterControl Supplier Corrective Action Request (SCAR) solution allows organizations to effectively extend the core of a continuous quality improvement system–corrective and preventive actions (CAPA)–to suppliers. The solution allows companies to broaden supply chain integration beyond purchasing in order to achieve truly comprehensive quality management.

MasterControl Supplier Deviation™

MasterControl Supplier Deviationcreates a formal process where suppliers can request an exception to written specifications. Materials are shipped only after the appropriate individuals have reviewed and approved the request and provided proper justification.

MasterControl Supplier Scorecard™

The MasterControl Supplier Scorecard solution empowers companies to rate their suppliers in a consistent fashion based on objective metrics. It creates permanent records around supplier-related quality events, such as supplier corrective action requests (SCARs), supplier deviations, manufacturing deviations, nonconformances, and variances.

MasterControl Variance™

MasterControl Variance provides an automated, formalized and consistent process for approving a variance against specifications. The solution resolves a number of key variance issues often caused by an inconsistent, unsafe system and disconnected processes.

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