Quality Assurance (QA) Document Control

Learn from industry practitioners and experts why QA Document Control is a prerequisite to Quality Assurance. Quality assurance document control is the process used in the management, coordination, control, delivery, or support of an item required for quality assurance purposes. QA document control is an essential part of the quality assurance system for all aspects of GMP, GCP and GLP. It allows you to approve, review and update documents; make changes and identify revision status; control document distribution; and prevent use of obsolete documents, facilitating proper archiving.


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Discover how MasterControl Quality Management System can manage your Document Control process, all while mitigating risk, improving speed-to-market, and generating ROI.

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  • With more than two decades of experience in rigorous FDA and ISO environments, MasterControl has developed an integrated software solution that combines industry best practices with the flexibility required to meet customers' unique needs. Learn how MasterControl software solutions not only help companies attain compliance, but sustain it year after year by optimizing quality and business processes and fostering efficiency.

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  • MasterControl offers the most complete choice of integrated solutions covering all core areas necessary to successfully maintain quality and compliance processes, as well as a variety of services based on industry best practices.
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  • Maintaining compliance and keeping pace with burgeoning workloads is especially difficult for companies doing business in regulatory spaces, most of whom are operating with outdated tools, manual processes, and fragmented approaches to quality management. This toolkit collects 20 MasterControl white papers, videos, and more expertly-developed resources designed to improve and streamline your company's quality management processes.

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  • A lack of quality can cost an organization millions of dollars in rework, scrap, recall or even liability lawsuits. This white paper shows how an optimized quality management system (QMS) can help a company avoid quality roadblocks and form the foundation for long-term regulatory compliance and, ultimately, for ensuring market success.
  • Quality management system (QMS) solutions can spare companies the unnecessary, and often staggering, costs of poor quality processes. Discover how market leaders are leveraging QMS software to make quality management improvements more strategic and sustainable.
  • Is it more cost-effective to build a homegrown system or to buy a proven and validated QMS? The answer varies according to individual organizational needs and this white paper will help you navigate toward the best solution for your company.
  • Learn how to articulate the business case for investing in an enterprise quality management system (EQMS). Explore five key ways to get buy-in from senior leadership when it comes time to establish or expand the EQMS.
  • Failure to meet FDA regulatory requirements can have devastating consequences. Find out what safeguards upper management should consider and what steps must be taken to ensure consistent, top-down regulatory compliance.
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  • Market-leading manufacturers are leaving outdated or disconnected quality management solutions behind. Find out why developing closed-loop quality processes, supported by quality management system (QMS) technology, is having a sizable impact on manufacturers' quality performance.


Quality Assurance Software Systems Facilitate Regulatory Compliance


In regulated organizations, quality assurance document control is essential to achieving quality and compliance. To control quality, you must control quality documentation, such as SOPs, policies, quality manuals, CAD files, and engineering change orders. QA document control facilitates organizing these vital quality processes.


No Quality Assurance without Document Control


A regulated business without a document control system is an invitation to chaos and FDA inspection. ISO quality standards and FDA Current Good Manufacturing Practices (CGMP) presume that both the process and documentation that directs company processes follows pre-approved methods and that any change to these methods is restricted to authorized personnel and tracked for future review. All FDA-regulated and ISO-certified companies are mandated to have a document change control system.

Quality assurance document control is achieved by using a document management system. Document management capabilities boost efficiency and ensure compliance by eliminating labor-intensive tasks like physically routing documents for approval, storage and distribution.

  • Format agnostic - The system must be able to control any document regardless of the application used to create (e.g, Word processing, spreadsheets, CAD, video, audio...)
  • Document lifecycle management - Having a quality assurance document control process means documents must be managed through their lifecycle statuses of Draft, Released and Archived. (See Figure 2) Lifecycles can be based on document type and need to automatically adjust document security based on lifecycle status.
  • Audit trail history / record archiving - A secure, time-stamped audit trail of all changes made to any record should be maintained and accessible to the appropriate users and departments. All of this information needs to be automatically captured and secured. Reporting functionality would track past versions, metadata and approval history of the record, from the time it was created until the present.
  • Centralized, Secure Repository - Documents should be securely stored to ensure only authorized access, while making it easy to protect against disaster.
  • Document cross-linking - In manufacturing environments, QA documents complement one another. For example, a form may be associated to a standard operating procedure (SOP), or an equipment manual associated with a maintenance drawing, etc. A document control system should allow document linking to provide users the relevant information needed to do their job.


How MasterControl's Quality Assurance Document Control Software can Benefit You


Document control and document management are essential to maintaining quality and compliance. To effectively achieve quality assurance document control, an organization must control quality documentation, such as SOPs, policies, quality manuals, CAD files, engineering change orders, etc. Here's how MasterControl Documentsâ„¢ handles some of the major challenges that companies face in managing and controlling documents.

  • Efficient quality assurance document control system - MasterControl's Document Control Software Systems automates routing, delivery, escalation, and approval of documents. It handles all kinds of documents, from CAD drawings to spreadsheets, regardless of the originating software. MasterControl also provides electronic centralized, secure storage that makes search and retrieval or documents easy during inspections and audits.
  • Automated Document Revision Control - MasterControl's document control software systems provide automatic revision control to ensure that only the current version of a document is available. This is yet another fact of quality assurance document control. Changes can be initiated and approved electronically. MasterControl automates routing, delivery, escalation, and approval of documents. MasterControl Documents allows authorized users to access the document needed at any time, day or night.
  • Enhanced Document Lifecycle - MasterControl allows for multiple lifecycle statuses, timed lifecycle movement, and flexible approval rules - all inherent in QA document control. Companies are able to build their product lifecycle within the system, simplifing routes and workflows.
  • Connected Document Control Processes - MasterControl Document Control Software Systems connect all quality subsystems such as CAPA, change management, audit, and training. For example, any CAPA that results in a document change will automatically invoke training once the change is approved. MasterControl is Web-based so documents are accessible to all authorized users from virtually anywhere.

For More Information on Quality Assurance Document Control


To learn more about how Quality Assurance Document Control can facilitate the work of QA and other departments, please feel free to contact a MasterControl representative.