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.

Many FDA-regulated companies are saving time and money by investing in automated quality management and document control systems. These systems require FDA 21 CFR Part 11 validation (see 21 CFR Part 11 Section 11.10a.)

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.

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MasterControl FDA 21 CFR Part 11 Validation Services and Solutions

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.

Full-Cycle FDA 21 CFR Part 11 Validation Consulting Services

MasterControl also provides full cycle validation consulting services for those professionals who may not have the time or manpower available to conduct IQ, OQ and PQ validation. The MasterControl Full Cycle Validation Consulting services include the development of user requirements specifications and functional requirement specifications, traceability between specifications and testing protocols for FDA 21 CFR Part 11 validation, a supplier evaluation, assessment tools and audit checklist readiness, ongoing quality and project plan management. SOP development and implementation, training, IQ/OQ/PQ process, final validation reports, final FDA 21 CFR Part 11 validation approvals and maintenance and follow-up services.

For More Information on FDA 21 CFR Part 11 Validation

To learn more about MasterControl quality management systems and validation solutions and services, please feel free to contact a MasterControl representative.