What is FDA CFR 21 Part 11?

FDA CFR 21 Part 11 establishes the Food & Drug Administration’s guidelines regarding electronic records and electronic signatures. It requires that computer systems which store data related to quality decisions include controls to maintain the trustworthiness and security of electronic records. Generally, Part 11 applies to drug makers, medical device manufacturers, biotech companies, biologics developers, contract research organizations, and other industries regulated by the FDA.

How does this impact testing software?

FDA CFR 21 Part 11 requires that there be an audit trail for all documentation related to quality testing. This requires that every change made to a procedure, test method, data, or report must be documented, recorded, and time-stamped. Failure to document such changes can result in delays in research and production, lost time and money due to down time, and ultimately, invalid results. Furthermore, to fully comply with Part 11, there must be a means to ensure that exported data cannot be altered by any party.

MTESTQuattro-fda-cfr-21-part-11MTESTQuattro and Part 11 Compliance

ADMET’s MTESTQuattro controller software helps to satisfy the requirements of FDA CFR 21 Part 11 by creating a documentation trail whenever there are changes to test procedures. These changes result in creation of a record which indicates what was changed, when, and by whom.

Furthermore, MTESTQuattro allows CFR 21 Part 11 administrators to limit the access users have within the program on an individual basis. This ensures that the manner in which tests are performed, i.e. test procedures, can only be modified by authorized persons.

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