FDA 21 CFR Part 11 Compliance

FDA 21 CFR Part 11 compliance is essential for those FDA regulated companies that wish to use electronic quality records and electronic signatures in place of their paper-based and ink-based counterparts to comply with FDA regulations faster and more efficiently.

Many companies want to make the FDA 21 CFR Part 11 compliance shift not just to comply with the FDA but to save large quantities of administrative time that otherwise would have been used to control documentation and quality management processes manually. If your company is looking to make the FDA 21 CFR Part 11 compliance shift consider the Part-11 compliant solution that MasterCotnrol, Inc. has to offer.

21 CFR Part 11 Industry Overview: Ready for an FDA Inspection?

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FDA 21 CFR Part 11 Compliance and Quality Management

Believe it or not, achieving FDA 21 CFR Part 11 compliance isn't as difficult as it may sound and since it allows for the consistent use of electronic documents and signatures related to quality, FDA-regulated companies will naturally benefit from more speed and more efficiency in their regulated environments. Companies simply need to select the right quality management system (QMS).


Achieving FDA 21 CFR Part 11 Compliance with MasterControl Solutions

Many of the MasterControl solutions have been designed specifically to meet FDA 21 CFR Part 11 compliance and the needs of companies and organizations regulated by the FDA. MasterControl's automated solutions directly address all of the regulations prescribed by 21 CFR Part 11. Here is a list of requirements and features:


FDA 21 CFR Part 11 Compliance Requirements

MasterControl Solutions

FDA 21 CFR Part 11 compliance dictates that those companies who use electronic systems for document and signature control must provide assurance that the electronic documents are authentic. The regulations all stipulate the necessity of the confidentiality of electronic records.

MasterControl addresses these needs with various levels of security (i.e, double-passwords) and the right to allow system administrators to stipulate user permissions to the system, to document collaborations, to document vaults and even to specified documents.

FDA 21 CFR Part 11 compliance dictates that all system users have the training necessary to perform their assigned tasks and projects.

MasterControl makes training easy by streamlining the delivery of training tasks, the delivery of online training exams, the grading of exams, training follow-ups, escalations and training reports.

FDA 21 CFR Part 11 compliance dictates that electronic records that are signed must contain a name, the signature meaning and the date/time of signing.

MasterControl provides fields for this required data and for additional data if so required.

FDA 21 CFR Part 11 compliance dictates that signatures whether electronic or handwritten be linked to their respective records.

MasterControl automatically links signatures to records and does not allow the link to be tampered with afterward to ensure FDA 21 CFR Part 11 compliance.

21 CFR compliance dictates that an FDA-regulated company's electronic system must be validated according to the FDA's validation standards.

MasterControl provides a host of ways to make validation twice as simple as it would otherwise be. MasterControl provides a validation toolkit, validation documentation, validation consultation and full-scale validation services.

How Does MasterControl Software Help With FDA 21 CFR Part 11 Compliance?

When your company is an FDA-regulated company there is so much to learn about MasterControl! In 1998, MasterControl Inc. introduced the first document control software especially designed to help the life sciences industry to achieve FDA 21 CFR Part 11 compliance. Since then, hundreds of companies worldwide have been using the MasterControl quality management suite™ an integrated, configurable, off-the-shelf, and easy-to-use software solution™ to comply with various FDA regulations.


Learn More About FDA 21 CFR Part 11 Compliance

Learn about FDA 21 CFR Part 11 compliance and how to streamline the automation of document control, quality management, business process management and product lifecycle management with MasterControl solutions.