FDA 21 CFR Part 11 Validation

Compliance with FDA 21 CFR Part 11 regulations requires the FDA 21 CFR Part 11 validation of a company's electronic quality management system.

MasterControl's Quality Excellence stands as a trusted partner for FDA 21 CFR Part 11 validation, offering a suite of services and solutions that streamline compliance. Our range caters to diverse needs – from quick-start validation packages with pre-written IQ and OQ scripts, to full-cycle validation consulting encompassing user and functional requirements, supplier evaluations, and more. Beyond validation, we empower Regulatory Affairs managers with insightful documentation, navigating the intricacies of FDA 21 CFR Part 11 with confidence. Whether you seek advanced toolkits or fundamental guidance, MasterControl ensures a path to meeting GAMP-compliant computer systems validation. Simplify complexities, embrace compliant excellence, and join those who have harnessed the power of MasterControl's solutions

Free Resources

21 CFR Part 11: 7 Ways to Avoid Noncompliance

21 CFR Part 11 Compliance Videos

Hundreds of companies around the world use MasterControl to automate core business processes and document management activities to promote collaboration, improve decision making, and accelerate time to market.

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Free 21 CFR Part 11 Validation Resources

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White Paper: Validating Software Systems to Comply with CGMP and 21 CFR Part 11 Regulations
Industry Brief: 8 Best Practices for Compliant and Quick Software Validation in the Cloud Industry Brief: 21 CFR Part 11: 7 Ways to Avoid Noncompliance
Data Sheet: MasterControl Validation Strategy and Advantages

MasterControl FDA 21 CFR Part 11 Validation Services and Solutions

The Part 11 validation requires careful testing and corresponding documentation. This documentation ensures that the electronic system has been programmed to perform the tasks necessary to maintain compliance with Part 11 rules and regulations. To easily streamline the FDA 21 CFR Part 11 validation process it is useful to ask the software vendor if validation documentation, tools or solutions are available. For instance, MasterControl, Inc., a developer of document control, quality management and product lifecycle software solutions, provides validation documentation, a validation toolkit, validation consultation, FDA 21 CFR Part 11 validation training and/or full-scale validation services.

To achieve FDA 21 CFR Part 11 validation, consider the services and solutions that MasterControl provides. These services include quick-start validation documentation packages which include IQ (Installation Qualification) and OQ (Operational Qualification) validation scripts that have been pre-written. Support services for IQ and OQ validation can also be provided.

MasterControl also provides a written validation introduction for Regulatory Affairs managers. The documentation outlines duties that need to be performed during the FDA 21 CFR Part 11 validation process and allows RA managers to understand the scope and commitment and meeting GAMP (Good Automated Manufacturing Practices) compliant computer systems validation. MasterControl also provides a Validation Toolkit for those professionals with little experience in validation. It's likely that these professionals will appreciate more than IQ, OQ protocols and a validation introduction. They can therefore take advantage of the FDA 21 CFR Part 11 validation Toolkit package which assists key personnel in completing validation requirements including PQ test protocols.