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A Quick Guide to Responsible AI for Forward-Thinking Organizations

  • Digiform Solutions

MasterControl and GDocP Compliance

Updated: Dec 5, 2023

MasterControl is a GxP software product with which DigiForm Solutions has a lot of experience. Over the past 25 years, MasterControl has grown from being an on-premise, locally-installed document control solution to a cloud-based SaaS suite of products to address the spectrum of GxP compliance.


There are seven areas of product development addressed by MasterControl products:

  1. Quality

  2. Manufacturing

  3. Clinical

  4. Regulatory

  5. Supplier

  6. Product Development

  7. Postmarket Management


As DigiForm has experience with MasterControl’s quality management suite and helping with implementing MasterContol and GDocP Compliance. We are qualified to provide an overview of how they encourage GDocPs.


As might be expected, DigiForm Solutions has worked most often with MasterControl’s quality modules. The quality suite revolves around the documents module: an area of the system designed to house and control documents.


There are many areas of GxP compliance and industry expectation that demand concurrent, legible and authenticated documentation, and the documents module helps capture and maintain all relevant information related to document control. 21 CFR Parts 11, 211, 1271, 820 and 606 all allude to GDocPs (Good Documentation Practices), and MasterControl can help comply with all of them. That being said, there are many other GxP requirements with which MasterControl helps a company comply.



MasterControl and GDocP Compliance
Document Control Lifecycle

MasterControl is an industry leader because their products and modules communicate with each other and can also integrate with external systems to provide companies with a single manufacturing software solution. Their cloud-based products also come with computer systems validation assistance that is patented. That being said, its wide range of abilities and various applications lend itself to a complexity not understood by many people outside of the company itself. DigiForm Solutions has configured quality suites from scratch, Spark products for small business, and enterprise-level suites for federal agencies.


Contact Us today to find out how we can help you configure and/or manage your MasterControl implementation!





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