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Software Validation Process for 21 CFR Part 11 is all about authenticity and integrity of electronic signatures and records. Care should be taken to avoid confusion and get validation right.
The FDA’s Code of Federal Regulations (CFR) is a collection of laws that regulate the various government agencies. Different titles of the CFR govern respective regulated areas.
Codes contained in21 CFR Part 11 relate to electronic records and approval signatures, which are digital versions of paper documents and handwritten signatures. 21 CFR Part 11enables
With the widespread proliferation, reach and prevalence of the use of computers; it is a given that people would like to use electronic records instead of paper records. CFRs became necessary as records graduated to the electronic format, because of which validation of these signatures for their authenticity also became necessary.
The software validation process for 21 CFR Part 11 is enshrined in the regulated company’s Standard Operating Procedures (SOP’s), which describe the way in which processes are to be performed. In the course of implementation of the software validation process for 21 CFR Part 11; any paper record, inclusive of signatures, is to be replaced with an electronic one, given that the computer system is validated and has appropriate features.
21 CFR Part 11 compliance consists of three primary areas: