MasterControl Features

MasterControl is a complete QMS solution. Click the sections below to see the highlights of our robust quality management modules

Integrated Platform Capabilities

The MasterControl platform is available with standard and add-on features that provide the configurability you need while maximizing your investment in an integrated quality management solution. Our solutions are designed to adapt to your changing demands and support growth as your business needs evolve.

Integrated Quality Management Suite According to our customers, MasterControl's greatest asset is that is combines all critical quality management processes within a single platform. By taking advantage of our integrated collection of robust quality management solutions, you can enhance your existing quality processes and streamline your compliance activities. Review some of the benefits in the Quality Management Suite Advantages below.
Regulatory Compliance MasterControl provides time-stamped audit trail, reporting, electronic signature, and other critical capabilities that fully satisfy FDA's 21 CFR Part 11, ISO 13485, Annex 11, and countless other global quality requirements for document control software systems. MasterControl's security functionality limits access to only authorized users. Features include dual passwords for document approval; password expiration, encryption, and certification; and account lockout to prevent unauthorized access.
Web-Based Platform MasterControl is web-based so it can connect all employees involved in document and quality management from virtually anywhere. Authorized users can access the system whenever they want, wherever they want.
MasterControl Cloud MasterControl's cloud-based QMS gives users secure anytime, anywhere access.
Role-Based Permissions MasterControl's collaboration functionality offers role-based security, which allows users to be in complete control of each process stage and restrict access as necessary. The system's automatic revision control functionality ensures that revisions can only be made by one authorized user at a time, so users won't make the mistake of using obsolete or unapproved documents.
Automatic Routing, Escalation, and Approvals Automated task assignment, routing, escalation, approval, and tracking facilitates accelerated processes, helps avoid potential bottlenecks, and increases management oversight. Automation simplifies the compliance environment, making it easier to maintain regulatory compliance, and MasterControl's secure virtual vaults streamline collaboration life cycles.
Customizable API The MasterControl API Toolkit allows for the creation of applications that can create, modify, or manipulate objects in MasterControl. It enables customers to better improve their information pipeline and exchange data between MasterControl and other core business solutions while maintaining system integrity. The toolkit facilitates connections with a variety of external systems for several applications, including ERP software, LIMS, LMS, MES, PDM software, and SPC software, among others.
Advanced Analytics and Dashboards MasterControl's analytics and reporting capabilities provide a real-time view of quality management processes. With the user-friendly graphical interface, any user can easily create a new report and configure it to meet their needs. There is no limit to the number of reports and report variations that users can create with the data they can easily search for, retrieve, and analyze in the system. The systems “Hubs” include dynamic tiles that provide a dashboard view of critical processes.
Search MasterControl functionality includes a range of basic and advanced search options. Users can save searches they need to return to frequently. MasterControl's centralized, secure document repository makes search and retrieval of essential documentation easy during audits and inspections.
Audit Trail Maintains a secure, time-stamped audit trail that documents the identity of anyone who creates, modifies or deletes any file, when the action occurred and the changes made to the record.
Taxonomy MasterControl Taxonomy Explorers™ allow every group within an enterprise to have its own unique taxonomy but also provides the capability to have a single document exist in more than one taxonomy. Critical documents (i.e., SOPs, drawings, contracts, clinical documents, or submission documentation) can be automatically updated by the MasterControl system and categorized as active, draft, or archived.
Mobile MasterControl users with mobile devices can participate in the quality management system where and when they want to. MasterControl's mobile capability extends the benefits of an automated system to the manufacturing area or any remote area outside of the company's headquarters.
Scalable MasterControl is designed to help companies of all sizes streamline common processes within and between every department across the enterprise. For smaller companies, MasterControl offers lighter varieties of its powerful, world-class software solutions. Large companies dispersed between multiple global locations can rely on MasterControl to better connect disparate sites and efficiently manage processes throughout the organization.
Rules-Based Automation Automate projects tasks using advanced logic. MasterControl allows for the automatic enforcement of business rules, which helps managers and employees streamline operational functions, maximize productivity, and solve issues in a more proactive way to ensure compliance. Adjustable thresholds can be set in the system to automatically notify managers when certain quality events occur.
508 Compliance Skin Users with visual impairments can turn on MasterControl's “Section 508 compliance” skin and they will be able to use a screen reader that goes through all the tabs and buttons on a web page, making it easier to select the appropriate tab or button. Going far beyond simply feeding documents through HTML, MasterControl is engineered to directly address Section 508 standards of screen reader compatibility, keyboard accessibility, and color/contrast functionality.
Translatable System If you have facilities overseas, MasterControl makes it easier to allow non-English speakers to use the system. A translatable version of MasterControl's documents module is available right out of the box. If you choose Spanish, for instance, the system switches to Spanish for your Spanish-speaking divisions and facilities.

Services and Support

At MasterControl, we combine our state-of-the-art software solutions with premium educational services and resources. Our educational services include MasterControl On-Demand online courses and resources, basic and advanced training sessions taught at MasterControl's Corporate Education Center in Salt Lake City, and on-site training sessions held at the customer's location of choice. Technical support is also available 24/7 to MasterControl customers via a self-service portal or by phone.

Technical Support MasterControl offers several levels of support, ranging from online self-help to one-on-one, in-person assistance. Self-service options let you decide the type of support that best fits your needs by accessing our knowledge base, reporting issues, and viewing your support cases. Three time-based support stages are available: Mainstream Support, Extended Support, and Ongoing Support. The unique UserVoice support feature lets users influence product direction and offer enhancement ideas.
Validation By minimizing the effort required to validate MasterControl software, our clients can focus on using our software to help provide life-changing products to more people sooner. Our validation philosophy is that customer Performance Qualification-level testing should be risk-based and focused on critical business processes that directly impact data integrity or patient health. Accordingly, we offer validation documentation in the form of an automated Transfer Operational Qualification (TOQ).
Implementation MasterControl's experts analyze your business processes, suggest new ways to manage them, and guide you through the systems that can put you back in control and help save you time and money. Our experienced experts meet with your staff—typically employees in IT, quality, regulatory compliance, manufacturing, and finance—to review your business flows, design better ways to accomplish organizational goals, and develop pain-free migration strategies.
Education MasterControl training is designed to accommodate you. We offer a variety of educational resources that help the entire spectrum of users and sysadmins gain a complete understanding of our software solutions with the goal of improving your organization's productivity and efficiency. Our instructor team is made up of experts that have years of real-world experience in regulated industries and who follow best-practices guidelines to teach software functionality from a problem-solving perspective.
Integration MasterControl's consultative services help clients save time, money, and frustration as we assist you in establishing a QMS plan that eliminates confusion and eases your compliance concerns. Let our experts show how MasterControl can help you bridge the functionality between your existing enterprise applications (such as ERP, PDM, MES, etc.). Integrating disparate information systems with MasterControl lets you boost efficiency and leverage existing data while maintaining system integrity.

Audit Management

For an organization to maximize efficiency and maintain regulatory compliance, it must perform regular audits. MasterControl Audit is an electronic audit management solution designed to facilitate regular audits by making them faster, easier, and more effective. MasterControl's audit management software integrates the many complex steps of the audit process—from preparation through completion—to ensure compliance.

Core Platform Features MasterControl automates the routing, notification, delivery, and escalation of audit tasks and provides a centrally-accessible and searchable repository for all audit documentation. It connects audits with overall quality processes and serves as the backbone of a comprehensive quality system that facilitates the efficient management of both internal and external audits. The system also integrates with an organization's existing document repositories and enterprise applications—like ERP or LIMS—without expensive custom coding. (To see more, expand Integrated Quality Management above).
Supports Multiple Audit Types MasterControl facilitates and automates audit-related tasks, activities, and reports for all types of audits, accommodating any variety of requirements and complexities. It enables multiple auditors to collaborate from a single virtual workspace and allows users to filter audits by type, status, or auditor (i.e., regulatory reviewer, vendor, internal, etc.). Global trending reports can be created as required by the circumstances of each audit.
Offline Audit Tool The user-friendly MasterControl system allows auditors to conduct audits with familiar Microsoft Word tools. Online or off, a plug-in allows auditors to capture their observations, rate the severity, categorize them, and so forth, all within the Word application. Auditors working offline may directly upload audit data once they're back online. Optional checklists can be configured and embedded directly within the tool.
Centralized Audit Workspace Audit teams can collaborate on each audit in MasterControl's virtual workspace. MasterControl allows teams to manage and collaborate on all audit documentation and information, such as audit type, dates, summary, scope, conclusion, team members, observations, etc. It also serves as the repository hub for gathering information like audit agendas, cover letters, and checklists.
Closed-Looped Quality Event Integration MasterControl integrates every step of the audit process, from preparation to completion. Modifiable system thresholds allow users to automatically determine what should be audited and how often. Quality event forms, such as CAPAs and SCARs, may be automatically launched directly from audit findings. The history of an entire audit's process is visible and links are continually maintained, which allows users to review a completed process and trace all actions back through an indisputable chain of events. MasterControl closes the audit loop by creating a final consolidated report that includes all data from the issued audit report, responses, and any actionable items.
Advanced Audit Scheduling Create a plan of all audit-related activities with MasterControl's simplified drag-and-drop audit scheduling calendar. Groups can be created that let viewers see audits by status, type, or auditor and can be filtered to display only specifically required views. Scheduling conflicts can be avoided thanks to functionality that automatically sends notifications and updates of appointments to auditors and displays potential conflicts (i.e., double-booked, out-of-office, etc.). The system can generate an automatic, risk-based schedule of future audits based on audit results or the relevance of the audited process, supplier, system, etc.
Automated Routing & Workflows MasterControl eliminates the time-consuming tasks of manually distributing paper audit reports to all stakeholders and locating appropriate personnel for signatures. The system enables users to designate different default approval groups for each type of audit and automatically distributes notifications when a report needs an approval. Electronic audit trails reveal who has signed off (and which signatures are missing) and can be included as signature manifests on issued audit reports.
Checklists MasterControl allows users to create multiple checklist templates for different audit types to ensure standardization across the enterprise. Users may import standards and criteria from industry regulations and/or configure checklist templates by selecting just the applicable sections. Auditors are given the ability to complete checklists online, on a mobile device, or offline in Microsoft Word for later upload.
Controlled Response Collection Assign observations to authorized internal users or to external responders via MasterControl's exclusive guest connection that permits direct response entries. The system includes fully customizable Microsoft Word templates that allow users to capture offline responses. Actions can be created and tracked directly from observations that have been collected.
Automated Audit Report Creation MasterControl saves time and effort by automatically generating rich-text final audit reports, ensuring that auditors won't have to reformat findings when preparing reports. Observations can be tracked and trended by finding, rating, and category to provide better insight into issues occurrences. A real-time view of the audit process is available through MasterControl's advanced analytics and reporting functionality, which includes customizable reports and online charting capabilities.
Core Platform Features MasterControl's automated bill of materials (BOM) management system controls all BOM iterations generated during the design process and enables users to exchange BOM data with suppliers. All departments can get an up-to-date, accurate view of revision levels of every component in their particular configurations. Documents defining components are easily viewable from the BOM, which ensures that the right documents and revisions are used in manufacturing. (To see more, expand Integrated Platform Capabilities above.)
Revision Control Each BOM is stored on a separate MasterControl InfoCard, allowing multiple revisions to be approved and used for reference. BOMs can be sent on collaboration routes directly from the system, which allows users to redline and propose changes without affecting the approved version.
Familiar Structure MasterControl's BOM management system provides a configurable yet consistent approach to creating, viewing, and handling BOMs. Users already accustomed to working with BOMs will find they are able to effortlessly organize product data using a familiar tool. Any BOM may also be copied within the system and used as the basis for new BOMs.
Auto-update When changes are made, the MasterControl system automatically provides updates with new revisions of component InfoCards, thereby creating new BOM instances in the process.
In Sync MasterControl keeps engineering BOM data synchronized with manufacturing BOMs by enabling integration with other related systems (such as ERP) and by providing BOM control. Different teams or departments can all have access to the most current BOMs throughout the design process.
Establish Connections and Track Changes The “where-used” feature displays exactly where a part is employed across multiple BOMs, permitting MasterControl users to determine the impact of a single part change and update subsequent changes where needed. Assembly or sub-assembly InfoCards are easily accessible within the system so users are continually made aware of parts under construction and sub-assemblies to which particular components belong.
Bulk Replace A single part used in many locations can be replaced simultaneously system-wide by using MasterControl's BOM solution to select the assemblies to be updated, components to be substituted, or components that require new revisions.
PDM Connector BOMs can be created or edited manually or through PDM interfaces like MasterControl's PDM connectors. MasterControl can take a BOM from a PDM solution and keep intact all the hierarchal relationships.
Advanced Analytics Exporting New “where-used” reports can be created for all single parts and assemblies to show every occurrence of a given item number's utilization. Hyperlinks within the reports provide direct links to associated BOM management records in the system. Users can also configure how data is exported and synchronized with ERP systems via the MasterControl API Toolkit™.
BOM Views MasterControl offers three unique methods of viewing BOMs. The Indented (Hierarchical) View gives access to all documentation associated with each component, including metadata. This view also features dynamic navigation and display of all the structures and sub-structures of a BOM. The same part may be displayed multiple times if it is included in multiple sub-assemblies. In the Summarized (Flat) View, each part is displayed just once in a list, allowing the user to view the total quantity of each part required and see rolled up costs. The Comparison View makes it possible to see the differences between two versions of the same BOM system record and displays additions, deletions, and modifications.

CAPA Management

MasterControl's corrective action / preventive action (CAPA) software solution is a robust, easy-to-use system designed to effectively manage CAPA processes and integrate them with other quality processes critical to regulatory compliance, such as change control, audit, and customer complaints.

Core Platform Features Automate the routing, notification, delivery, and escalation of CAPAs and all CAPA-related documentation with MasterControl. The solution provides a central repository for all CAPA documents on a single platform that makes search and retrieval simple. With InfoCards, the MasterControl tool that summarizes information about each document in the system, users can easily connect any document to its associated processes throughout the enterprise. The system's robust CAPA analytics functionality provides a superior alternative to manual report creation or costly specialized reporting software. (To see more, expand Integrated Quality Management above.)
Best-Practice Forms MasterControl provides best-practice electronic CAPA forms and workflow routes that work right out of the box or can be configured to meet company requirements. The workflows guide quality teams through each step of CAPA implementation, from identification of the problem to investigation of root cause through correction and prevention of recurrence. Forms can be configured to show only information relevant to specific steps or to just require completion of fields that relate to particular instances.
Configurable Data Collection Ensure that all relevant CAPA data is captured and that decisions—as well as supporting rationales—are precisely documented in MasterControl. Data can be summarized on multiple levels, which allows users to report CAPAs by product, department, or root cause. In addition, data can be grouped by intervals and then charted over given ranges. Flexible configuration options enable the creation of a rigorous, customized process, an open, user-managed process, or anything in between, based on organizational requirements.
Closed-Looped Quality Event Integration A "closed-loop" solution that streamlines processes, MasterControl integrates quality subsystems, and tracks any quality incident that could escalate into a CAPA. Throughout each phase, the system maintains links so users can review a completed process to easily see what triggered the CAPA. CAPA forms can be launched directly from another form (i.e., customer complaint, audit finding, etc.), making quality processes more efficient. Any relevant data from other forms that could potentially require corrective action is automatically transferred to a CAPA form, thereby reducing data entry and potential manual errors. Also, any CAPA that causes a product change can be set to invoke training tasks upon change approvals.
Automated Routing & Workflows MasterControl includes best-practice configurations with built-in workflows that can be used as is or configured to meet company needs. The routing, notification, delivery, and escalation of CAPAs and all CAPA-related documentation is automated.
Third Party Collaboration Vendors, off-site users, customers, or other external parties to submit quality events, such as customer complaints or product issue reports, via MasterControl's online portal. Even when not connected to the system, remote users can complete forms pertaining to the CAPA process for upload at a later date. The system can also automatically distribute and grade online exams, which can be used as proof of personnel competency during audits or regulatory inspections.
Advanced CAPA Reporting & Tracking MasterControl provides metrics on the frequency, types, and classification of quality events that could potentially escalate into CAPAs (i.e., deviations, nonconformances, etc.). Users can dynamically capture, trend, and link data needed to solve problems and implement preventive measures before difficulties arise. Managers get a real-time view of CAPA processes, which enables them to be more proactive about quality improvements. Reports can be customized according to certain needs, such as issue review or problem prevention.

Complaints Management

MasterControl Customer Complaints allows companies to establish a unified, closed-loop customer complaint management system for recording and tracking complaints across processes, departments, and geographical locations. By automating and integrating all complaint-related tasks, such as data collection, notification, follow-up, and escalation, MasterControl makes it easier to comply with rigorous quality regulations.

Core Platform Features MasterControl provides a centralized platform for logging customer complaints and storing all subsequent documentation that pertains to the investigations into and correction of problems. The search and retrieval of complaints and related data is easy within the integrated system and all complaint-related data is perpetually audit ready. (To see more, expand Integrated Platform Capabilities above.)
Complete Complaint Handling Lifecycle MasterControl makes customer complaints management easier and more efficient by facilitating a simple three-step process of complaint processing, investigation, and resolution. The total lifecycle of each complaint is reduced by MasterControl functionality that streamlines each step and consolidates multiple sources of complaints within a single system.
Closed-Looped Quality Event Integration MasterControl integrates customer complaint handling with the corrective and preventive action (CAPA) process to automatically escalate serious quality problems. All activities related to complaints and CAPA—such as triggering events, root cause analysis investigations, and follow up assignments—can be automated and effectively handled within a single platform. The seamless integration of all quality processes within a connected is what sets MasterControl's complaint management software apart from other solutions.
Best-Practice Forms By providing preconfigured, multi-page electronic forms that ensure accurate complaint data capture, MasterControl condenses the documentation portion of the customer complaints management system into a simple three-step process: complaint processing, complaint investigation, and finally, complaint resolution. Every phase of the process is automated and effectively documented.
Configurable Data Collection Right out of the box, MasterControl provides a viable foundation for managing customer complaint data that can be tailored for a custom fit to your organization as business or compliance needs change over time.
Configurable Decision Trees MasterControl features built-in, configurable decision trees designed to facilitate the appropriate evaluation of complaints for medical device reporting (MDR) purposes. This functionality ensures that all MDR event files are appropriately documented and electronically maintained in a centrally accessible repository. For compliance purposes, the system continually maintains secure, time-stamped audit trails that record the identity of everyone who creates, modifies, or deletes customer complaint files.
Automated Routing & Workflows MasterControl ensures the accurate capture of complaint data and automates the routing and management of related tasks. The system's configurable workflows electronically route tasks to appropriate personnel and can be set to escalate important tasks to supervisors when timelines are not met.
Flexible Data Collection Because it is web-based, the MasterControl system allows users to log complaints from virtually anywhere. The preconfigured forms built into the system ensure that complaint data is captured accurately. All recorded form data is connected and accessible enterprise-wide.
Advanced Reporting Capabilities MasterControl provides advanced analytics and reporting tools that allow for increased management oversight. This enhanced transparency improves decision-making throughout each phase of customer complaint management. The solution includes the following customizable reports: complaint summary; complaints categorized by type, product, and department; in-process complaints; and trending categorized by complaint type, product, and department. It also includes the FDA's MedWatch 3500A form for mandatory reporting of adverse events.
eMDR Integration An optional HL7-compliant eMDR solution is available that integrates with customer complaints and supports electronic reporting to the FDA. All MDR event files are appropriately documented and maintained per regulatory guidelines. By facilitating electronic filing, MasterControl saves time and resources and helps ensure that the reporting and submission of MDR data is timely and consistent.

Document Control

Seamlessly connecting document management with other quality processes is the most effective way a company can make overall improvements and achieve compliance. MasterControl automates and efficiently manages document control processes to help ensure compliance with FDA 21 CFR Part 11 regulations, ISO quality standards, and other regulatory requirements.

Core Platform Features MasterControl automates task routing/assignments, scheduling, follow-up, escalation, review and approval of all documents-based processes. It provides a secure repository for all documentation on a single platform, which makes it easy to search for and retrieve documents. With InfoCards, the MasterControl tool that summarizes information about every document in the system and serves as a placeholder for the document in the database, users can connect any document to its associated processes throughout the enterprise. The solution's robust analytics functionality provides a superior alternative to creating reports manually or investing in costly third-party reporting software. (For more information about MasterControl's core platform features, expand Integrated Quality Management above.)
Supported File Types While most software solutions are engineered to handle only designated file types, the format agnostic MasterControl system can manage any type of file as a document (with the exception of some instances of .exe files) regardless of the format used to create it.
Automated Routing & Workflows MasterControl automates the entire lifecycle of a document, from creation to approval, distribution, retrieval, and obsolescence. By automating tasks like document routing, follow-up, escalation, and sign-off, the system drastically reduces document cycle times and facilitates compliance. The MasterControl system enables users to configure document lifecycles with multiple statuses or phases, which and substantially simplifies workflows and routes and perfectly aligns with an organization's daily business processes. System “vault bloat” is alleviated with MasterControl, since vaults can be tailored to teams and departments rather than according to document type. Combining flexible approval rules with lifecycle phases makes it easier to model a product's lifecycle, regardless of complexity or uniqueness.
Version & Revision Control When a new revision of a document becomes effective, MasterControl cuts off access to the prior revision and ensures that only the current revision is available. Automatic revision control prevents users from mistakenly using obsolete or unapproved documents. The system also automatically tracks revision history, including reasons each change was made, when it was approved, who approved it, and which approver signed off.
Document Retention & Archiving The length of time a document will last in the system can be set to any desired timeframe, based on the organization's desired retention policy. Retention can also be configured by document type. Additionally, the system's document revision control functionality ensures that expired documents are electronically archived and that only the most current version of a document is available, so users are prevented from working with obsolete or unapproved documents.
Audit Trails MasterControl's automated archiving and cataloguing functionality ensures that audit trails are maintained in accordance with regulatory requirements. The system tracks documents by status (in process or complete) or history and ensures that revision/approval histories are reviewable at any time.
Change Control MasterControl helps manufacturers automate and effectively manage each step of the document change control process via best-practice forms that have been preconfigured to facilitate efficient data collection and tracking. Different types of changes can be routed to the appropriate user groups, thus maximizing the efficiency of change control processes. The system automates basic change control tasks like review scheduling, review assignments, and reminder notifications. It also allows users to track changes between revisions of an item.
PDF Publishing Preserve record format and integrity by automatically converting documents to PDFs using MasterControl's PDF publishing functionality. MasterControl meets 21 CFR Part 11 requirements for signature manifestations by embedding a list of all signatures into each PDF, which minimizes the risks commonly associated with both electronic and hard copy rogue documents. Uncontrolled documents can be eliminated via date stamped printed copies and by enabling electronic copies to “self-destruct” on a set date.
Taxonomy & Explorers MasterControl allows any group within the enterprise to have its own unique taxonomy, but it also makes it possible for a single document to exist in multiple taxonomies within the system. Critical documents (like SOPs, clinical documents, or any type of submission documentation) are automatically categorized and updated. In addition, MasterControl's powerful Explorer tools allow users to arrange documents in the way that makes them most accessible. Users can quickly access files and associated metadata, designate favorite documents or locations, and export files all within MasterControl's Explorer interface.
Virtual Collaboration Workspace Collaborate with different teams—regardless of geographic location or time zone—in MasterControl's virtual, web-based collaboration space. System access can also be granted to authorized external parties, such as consultants and suppliers, for collaboration purposes.
Controlled Copies Any authorized MasterControl user can print controlled copies that are uniquely numbered, watermarked, and tracked. Copies may include a customizable watermark, sequential numbering, and location traceability. This feature is ideal for companies that need to copy, print, and distribute controlled documents to their manufacturing lines, suppliers, or other locations.
Easy Document Loading MasterControl makes document creation easier than ever before by giving users the ability to drag and drop new documents into preconfigured network folders. The system can even automatically launch a collaboration for a new document or automatically send it on a preconfigured approval route.
Metadata Linked to Document MasterControl's linking functionality helps eliminate common problems with out-of-sync metadata during revision processes. When revising a document, updated information (like document number and revision number) can be automatically transferred to the document header from the InfoCard, the MasterControl tool that provides basic information about a document.
Customizable Metadata & Fields MasterControl grants system administrators the ability to build folder structures based on the metadata that works best for their user groups. This allows individual users to view information in the way that makes the most sense to them. Each document is automatically updated as soon as it is saved, based on information pulled from the fields and metadata found on its associated InfoCard, the MasterControl tool that summarizes the basic information about each document in the system.
PDF Binders The system can consolidate multiple files into a single PDF for distribution. The PDF binder automatically compiles the date and time and generates a table of contents.

Risk Management

MasterControl risk analysis software establishes risk evaluation as a discrete, critical process. The solution provides a complete and accurate picture of the risk landscape across product lines, business processes, and business units and helps companies avoid reputation damage or legal infractions caused by recalls or regulatory actions. It serves as a “one-stop shop” that unites all risk-related activities and documentation within a single, centralized repository. (To see more, expand Integrated Platform Capabilities above.)

Best-Practice Risk Form A pre-configured, multi-page form prompts participants to collect and track all relevant data and guides them through data management processes while allowing the personnel responsible to make judicious, timely decisions. The form is automatically routed to designated approvers and can be escalated if it is not processed in a timely manner.
Standardized Best-Practice Process MasterControl incorporates a two-step process that uniformly guides users through each phase of risk analysis performance and risk analysis approval. The output is a risk score that is based on a consistent process, which enables quality departments to reduce the oftentimes subjective nature of quality decision-making. MasterControl's best practice approach also incorporates risk mitigation and reassessment.
Uniform Risk Management Methodology Throughout all risk evaluation and mitigation activities, the integrated MasterControl system ensures that predetermined risk tolerance thresholds are employed and followed across the enterprise. Regulatory and quality departments are armed with unvarying methods to perform consistent risk analyses while engineering and manufacturing personnel have the capacity to easily document and store risk mitigation activity records during product and process design phases.
Robust Risk Assessment Capabilities Users are given the ability to configure multiple risk types for evaluating different categories of operational risk. Risk assessments can be launched from anywhere within the MasterControl system, allowing users to quickly analyze any potential hazards associated with a particular process or activity.
Analytics Reporting Tool MasterControl software comes with a built-in risk analysis tool that includes a standard set of pre-configured reports that may be customized by the user or used as is. The risk analysis reports can be generated based on the source or according to other parameters. These data-mining capabilities provide vital insight into systemic quality issues and can serve as a launching point for corrective and preventive actions (CAPA).
Audit Trails and Electronic Signatures MasterControl software includes time-stamped audit trail, reporting, and electronic signature capabilities that fully satisfy FDA 21 CFR Part 11 and other global regulatory requirements.
Integration Points Risk assessments can be launched from any MasterControl form (e.g., CAPA, NCMR, etc.). Assessments launched from any item (such as a document, process, project, or BOM) anywhere in the system are automatically linked to all related InfoCards within MasterControl. Risk files associated with vendors provide the ability to monitor and accurately track the risk-related activities of authorized third parties.
Increased Management Oversight The system's standard methodology simplifies the application of resources in the most risk-prone areas and ensures that organizational risk tolerance thresholds are not exceeded.
Enhanced Risk File Management As a single collection point for all risk-related activities pertinent to a given project, process, or supplier, MasterControl brings together risk assessments, documentation, and other risk management processes (i.e., FMEA, FTA, surveys, etc.) under a single platform. Risk files may be routed for approval and electronically authorized in accordance with regulatory requirements such as 21 CFR Part 11.
Connected Processes MasterControl provides employees from different departments with a simple and efficient method for participating in risk assessment and mitigation activities within a single, integrated platform. Electronic workflows and signatures simplify the execution, review, and approval of all risk-related activities and documentation. Personnel also have the capacity to leverage a risk-based approach in a variety of quality processes such as nonconforming material disposition, CAPA, protocol development, and supplier qualification activities.

Supplier Management

MasterControl supplier management software gives companies the ability to efficiently manage and approve vendor lists and effectively track supplier quality and status. The system serves as a centralized repository for automating, maintaining, and controlling all supplier quality data and documentation – from non-conforming material reports and audit observations to contracts and service level agreements. With MasterControl, companies can efficiently manage and monitor supplier status and ratings, records, CAPAs, AVLs and more.

Core Platform Features MasterControl's supplier management software provides a complete system for managing each supplier's quality information – approval status, non-conformances, deviations, SCARs and more – in a single place. By taking an integrated, holistic view of supplier management, rather than viewing each piece in isolation, MasterControl allows companies to execute and maintain a comprehensive and integrated supplier management system. (To see more, expand Integrated Quality Management above.)
Supplier Qualification Improve the management of all qualification documents and processes with routes, steps, high-risk initial audits, and qualification audits to ensure continuity of supply, compliance, and product quality. MasterControl enables you to manage initial lot inspects for certifying a supplier and to share supplier qualification data with personnel across multiple locations.
Document Management Automate the entire lifecycle of your documents, including those pertaining to your supplier corrective action request (SCAR) process, and maintain a single repository for all supplier quality-related processes and documentation. Automate critical processes with MasterControl and you will have all relevant information in one place while also reducing document cycle times.
Approved Vendor Lists (AVLs) Effortlessly monitor and maintain AVLs, and make all records and documentation related to each supplier easily accessible to the relevant personnel. MasterControl enables you to automatically track and store each supplier's approval status and other critical supplier information, as well as ensure that AVLs are up-to-date and available across the organization.
Supplier Deviations Allow suppliers to request exceptions to written specifications before material is shipped, and automate your data-collecting and -control processes. MasterControl helps ensure materials ship only after the appropriate people have reviewed and approved the request and provided proper justification. Supplier deviation data is captured and stored for in-depth analysis and reporting.
Supplier Corrective Action Requests (SCARs) Streamline all tasks related to your SCAR process, including routing, follow-up, escalation and approval of all documents. MasterControl improves your ability to collect and track data from the request phase through approval, and to connect the SCAR process with other quality processes (e.g., launch a SCAR form directly from a supplier deviation).
Supplier Parts and Services List Simplify the process of adding and tracking parts and services. With MasterControl, you can add parts or services to your “approved to supply” list simply by linking them to a specific supplier. If a part is linked to an unapproved supplier, the link is disabled until the supplier is approved or reapproved.
Scorecards Ensure your suppliers maintain an acceptable level of quality by measuring their performance and rating them in a consistent fashion based on objective metrics. With MasterControl, you can collect and track data throughout the supplier scorecard process and create permanent records around supplier-related quality events, such as SCARs, supplier deviations, and non-conformances.
Supplier Risk Management Monitor supplier parts issues and make informed, risk-based quality decisions by gaining greater access to quality-related data. MasterControl automatically tracks and stores supplier information from audits, deviations, CAPAs, and more, which can easily be compiled to help identify and mitigate risk, evaluate supplier performance, and determine supplier quality ratings.
Supplier Audits Automatically track and store information derived from supplier management audits. MasterControl securely stores supplier audit information, approval status, and links to quality assurance auditing and analytics reports. You're able to maintain all supplier quality information in a centralized repository and make it easy to find suppliers that meet audit requirements.
Guest User Access Enable trusted suppliers to connect to a secure online collaboration space. Securely bring supplier contacts directly into the system and give them practical interaction capabilities – for example, reviewing and offering edits against a specification, contract, quality agreement or other document type – without giving them a full-access account. Increase collaboration while maintaining security.

Training Management

MasterControl Training is a robust, easy-to-use training management solution designed to effectively establish efficient employee training programs and integrate them with other processes critical to regulatory compliance, such as CAPA, change control, audit, and customer complaints. MasterControl's training tools are proven to help companies prevent quality problems and they demonstrate to regulatory authorities that organizational policies are in alignment with quality standards.

Core Platform Features MasterControl electronically notifies users of new training tasks via administrator-defined routes. Since it is integrated with the overall quality system, MasterControl immediately informs all affected trainees of new tasks whenever a document linked to a required course is changed. Verifiers are also alerted when tasks are completed. All trainees' records in the system are completely searchable and audit-ready. (To see more, expand Integrated Quality Management above).
Automated Routing & Workflows MasterControl automates the assignment, monitoring, and verification of training tasks, which allows training coordinators to focus on training effectiveness and the quality of curriculum content. The solution is a comprehensive employee training management tool that provides trainees access to records that show past training, course due dates, and any upcoming required training.
Escalation of Incomplete Trainings To reduce the amount of time wasted by supervisors attempting to track and report on unfinished training courses, MasterControl provides automatic escalation of overdue tasks according to schedules and hierarchies determined by the system administrator. Task notifications can be sent to multiple verifiers, meaning that when a particular supervisor is not available to verify a task's completion, another verifier can execute it to ensure timely verification.
Multiple Training Types MasterControl allows curricula to be developed in a variety of formats, such as controlled document review, computer-based training, on-the-job training, assessments, and instructor-led training.
Job Code Matrix This feature gives managers an up-to-date view of the training status of employees who have been grouped by job code. At a glance, the status of each course assigned to every employee and the completion percentage for that job code is readily apparent.
Exams for Competency Testing MasterControl automates the grading of online competency exams. Tests can even be configured so questions are selected randomly, helping to ensure a trainee understands a task before proceeding to the next training level. Exam designers have the option to alert trainees when questions are answered incorrectly. When required, learners can be automatically directed to specific parts of course materials they need to review. Learners who are interrupted while testing are able to save their exams and pick up where they left off whenever it suits them.
Progressive Training Sequence MasterControl allows administrators to develop a progressive training program through sequenced training courses. As soon as a trainee completes a prerequisite, the system automatically launches the next course in the sequence.
Group Sign-off If your company trains hundreds of employees at once, verifying and signing off for each trainee can be time-consuming. With this feature, the course instructor or verifier can sign off once for large groups of trainees. Administrators can even sort courses by name and then select all users who have taken the course and sign off for them.
Monitoring and Gap Analysis The MasterControl system's advanced analytics and reporting functionality automatically performs gap analysis for all trainee tasks and provides online charting and customizable reports that increase visibility into the status of training programs.
Multimedia Support MasterControl has the capability to add multimedia materials, such as pictures and videos, for a more compelling and extensive testing experience. This is especially beneficial for training courses centered on complex topics that are best described visually.
SCORM-Compliant Courses MasterControl is compliant with SCORM (Shareable Content Object Reference Model), the de facto technical standard for e-learning software products. SCORM compliance enables interoperability between e-learning software and learning management systems, including MasterControl. Whether you create your own training content or use third-party sources, your end users will be able to access it easily in MasterControl's SCORM-compliant environment.
Required Course Materials Users who have not attended a training class or opened the assigned course material will not be able to sign off on the associated task. This feature enforces training completion and compels users to open assigned materials and fulfill required training tasks.

Batch Records

MasterControl's electronic batch records system contains all the tools you need to create your electronic batch record forms, meeting all the requirements of Part 11. Our experienced process consultants will lead you through project scoping, requirements gathering, implementation, testing, validation, and go live activities to deliver EBR software solution that truly meets your organization's needs.

Core Platform Features Quickly explain Analytics, Info Cards, Search, Routes, (To see more, expand Integrated Quality Management above).
Complete Data Capture All user entries are captured, electronically stored, and available for reporting in the EBR software. This includes loading of external files, making them part of the batch record.
Data Integrity Checks Each field can run automatic checks to ensure that the data entered is in the correct format. Missing data, incorrect date formats or incorrect units of measure will never be a problem with MasterControl's EBR software.
Automated Calculations Calculation logic ensures that each data item only has to be entered once and can feed into calculations such as yield calculations or recipe amount calculations. Never worry about accuracy of calculations again.
Performer/Witness Signoff Each signature point can be configured for a single signature or Performer/Witness signatures within an electronic batch record systems. Performer/Witness signature points allow two users to submit their signatures from a single signoff window.
Parallel and Sequential Processing Processing steps can be set up in a combination of sequential and parallel units.
Integrates with Deviations Every manufacturing process needs a mechanism to deviate from the prescribed procedure, but controls must be in place to ensure that a deviation is acceptable. MasterControl's electronic batch records software seamlessly integrates the recording, assessment, and approval of a planned or unplanned deviation into the overall manufacturing process. MasterControl's EBR and Deviations solutions also link to other quality management modules such as MasterControl Nonconformance and MasterControl CAPA.
Analytics Reporting Tool This built-in tool of an electronic batch records system comes with a standard set of pre-configured reports that can be customized by the user. Production records can be trended and analyzed by product, recipe, process stage, etc. These “data-mining” capabilities provide important insights into overall production activities such as turnaround, quality issue rates, etc.
Compliant System As with all EBR software developed by MasterControl, the solution is fully compliant with 21 CFR Part 11 regulations, providing time-stamped audit trails, reporting, and electronic signature capabilities. Security features include dual passwords for document approval as well as password expiration, encryption, and certification.
Unparalleled Validation MasterControl considers validation an integral part of solutions for FDA-regulated customers. MasterControl's revolutionary approach to validation dramatically cuts the time, effort, and cost of validation, making it easier to validate future upgrades.

Additional Products

MasterControl provides a host of end-to-end software solutions specifically designed to help life science, general manufacturing, and similar types of companies meet quality, clinical, submissions, product lifecycle, and other regulatory needs. MasterControl's products are designed to reduce costs and assure compliance while helping customers get products to market faster.

Projects MasterControl Projects™ automates the process of controlling projects, particularly those that are document and/or process-based. The solution automates task assignment, routing, escalation, and tracking. It streamlines workflows and provides project transparency that fosters accountability. With MasterControl's project management software, project plans always maintain their connection to the project tasks and/or milestones.
Explorer Gateway To guarantee consistency of documentation, companies must integrate quality initiatives into the corporate culture organization-wide. The MasterControl Explorer Gateway™ responds to those demands by ensuring control in assembling and tracking documentation. It allows for the creation of controlled copies of documents that can be used for a variety of purposes, such as audits and off-site use, and ensures quality content in regulatory submission documentation.
Submissions Locker MasterControl's Submissions Locker™ is an indispensable tool for ensuring that submissions-ready documentation is maintained throughout a submission's lifecycle. It provides a secure environment that is accessible to any publishing tool preferred by the user. Works in tandem with MasterControl's enhanced Submissions Gateway™, the Submissions Locker helps users better prepare and control electronic submissions to regulatory agencies by supporting a full lifecycle for creating submissions.
Submissions Ready MasterControl Submissions Ready™ allows organizations to accelerate the preparation and organization of submissions documents utilizing FDA- and ICH-compliant submissions templates in combination with MasterControl's unrivaled document management solution. This integrated solution ensures that authors are using the most up-to-date version of a template and that submission documents are securely stored and organized in a logical file structure.
Deviations Management MasterControl Deviations™ automates and manages the process of documenting, investigating, and resolving operational deviations from written procedures and specifications. It enables users to resolve deviations efficiently and to use data collected as a basis for continuous quality improvement. Deviation owners can leverage the collected data to identify bottlenecks and better understand sequences of events as processes progress.
Device History Records (eDHR) MasterControl's electronic device history record (eDHR) software solution provides an online platform for designing, managing, and controlling eDHR files that depend on multiple inputs. It allows device manufacturers to migrate from highly error-prone paper forms system to an automated, dependable system and eliminate incorrect or duplicate data entry. The system's automated routing, notification, escalation, and approval functionality and best-practice forms facilitate faster turnaround.
eProcess Automation MasterControl eProcess software solutions provide powerful and intuitive toolsets to model any process, using a graphical workflow designer. User access security, complete audit trails, and electronic signature capabilities enable compliance with even the most stringent global regulations and standards, such as FDA and ISO.
Equipment Calibration MasterControl Equipment Calibration™ manages your organization's equipment calibration schedules and automatically triggers calibration events before they are due. The solution electronically routes calibration tasks containing specific instructions to the appropriate personnel for completion and review. A complete record, including calibration data, is stored for managers' records and for inspection by regulatory agencies or other external or internal auditors.
Equipment Maintenance MasterControl Equipment Maintenance™ automatically manages the maintenance schedule for your company's equipment and automatically triggers maintenance tasks before they are due. The solution electronically routes tasks containing specific instructions to the appropriate personnel for completion and review and automatically maintains audit-ready information.
HR / Finance MasterControl automates the administrative processes that bottleneck the flow and timely completion of essential human resources and finance department tasks. The solution's preconfigured forms help to streamline new employee checklist management, employee exit checklist management, paid-time-off request management, and purchase order fulfillment. It also automates the delivery of notifications and follow-ups and provides the ability to approve HR/finance forms with electronic signatures.
Incident Reporting MasterControl Incident Reporting™ serves as a pre-screen system to capture a wide variety of quality and non-quality events and to route or escalate issues through the appropriate channels. Issues such as non-conformances, deviations, variances, and customer complaints are escalated to quality events, while non-quality occurrences can be routed to other function, like human resources departments.
Nonconformance Management MasterControl Nonconformance™ is a configurable and easy-to-use solution designed to automate, manage, and streamline the process for identifying, evaluating, reviewing, and handling of nonconforming materials, components, parts, and finished products. MasterControl's best-practice form and five-step process connect all responsible personnel for effective and timely disposition of nonconformances.
Out of Specification Regulatory-minded clients rely on our OOS software to automate the collection and control of data critical to compliance. Built-in forms offer the ultimate design, routing, and user/security role flexibility. The system provides advanced tracking functionality, incorporates escalation, and offers best-practice features that prompt users to reduce data entry and avoid common data entry errors. Captured data is automatically stored in an ODBC-compliant database and can be used for analysis.
PDM Connectors MasterControl provides PDM connection tools and integrations with best-of-breed software solutions to complement your existing PDM solutions. The easy-to-use connectors for the PTC® Pro/INTRALINK® and Windchill™ solutions allow for collaboration and redlining on PDF drawings while guaranteeing that PDF copies in the MasterControl system stay in sync with native CAD files in the PDM solution.
Product Lifecycle Management (PLM) MasterControl's PLM software solutions serve as an organization's single source for product definition and provide a central repository for all drawings, specs, manufacturing procedures, inspection criteria, marketing collaterals, bills of materials, etc., that can be accessed from anywhere in the world. In addition, MasterControl solutions seamlessly integrate with other enterprise applications used throughout your organization on a regular basis (e.g., CAD, Microsoft Office, etc.).
Risk Analysis MasterControl Risk Analysis™ establishes risk evaluation as a separate process in your organization. The system outputs risk scores based on a consistent process, which enables quality departments to reduce the subjective nature of quality decision making. The solution is founded on a methodology that establishes objective risk metrics and allows for the automatic execution of risk analyses when set thresholds are met, resulting in consistent, objective, and defensible decisions.
Submissions MasterControl submissions solutions allow organizations to accelerate the preparation and organization of submissions documents. Every step of a pharmaceutical manufacturer's change control process—from submission through actual implementation, verification, and close of project—can be automated and effectively managed by MasterControl.
Supplier Deviation The MasterControl Supplier Deviation™ solution establishes 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. The solution's inherent design, routing, and role flexibility easily adapts to the way your company does business.
Variance The MasterControl Variance™ software solution offers a formal mechanism for evaluating whether a material that fails its quality attribute specification should be accepted or not. The system automatically routes requests to appropriate internal personnel for final decisions. The rationale for decisions on variances are recorded and retained in MasterControl's secure, centralized repository, which creates a permanent record and supports future audits, reviews, and/or investigations.
eMDR MasterControl's electronic medical device record (eMDR) software solutions are designed to meet FDA/GxP requirements for forms processes, including compliance with 21 CFR Part 11. The solution appropriately documents and maintains all MDR event files—including a summary log of events that have and have not been reported—in MasterControl's central, secure repository. It ensures that reporting and submission of MDR data is timely, consistent, and according to regulatory guidelines.
Meeting Notes MasterControl's Meeting Notes software solution improves the productivity of your meetings by maintaining meeting minutes in a centralized repository and automating action item follow-up. Action items can be automatically launched directly from a meeting minutes page and the system can be leveraged to track down any “loose-end” tasks. Meeting facilitators can establish meeting agendas that allow participants to make edits and stay in the loop.