PMT Services>Projects>21 CFR Part 11
21
CFR PART 11
|
Electronic Records; Electronic Signatures 21 CFR Part 11 provides criteria under which the FDA will consider electronic records to be equivalent to traditional hand written signatures. Part 11 applies to all computer systems that create, modify, maintain, archive or retrieve electronic records required by the FDA for inspection or submission under a predicate rule. Part 11 specifies procedural and technical controls needed for computerized systems utilizing electronic records and electronic signatures. These controls include: Validation, Security, Audit Trails, and Records Retention. The FDA requires all regulated firms in the industry that distribute products in the United State, such as GMP, GCP, GLP, and Quality Systems - Medical Devices, to comply with 21 CFR Part 11 if electronic records and/or electronic signatures are used. Network computer, stand alone computer, applications developed on desktop and process control systems (new and old) must be identified and evaluated if Part11 applies. If so, it must be included in the plan to achieve Part 11 compliance. The evaluation process is a checklist of questions to determine if the system directly or indirectly affects manufacturing. When Part 11 is implemented, FDA considers the electronic records produced to be trustworthy, reliable, and equivalent to paper records and handwritten signatures executed on paper. The FDA expects pharmaceutical, biotech, and medical device firm to comply with 21 CFR Part 11.
|