FDA 21 CFR Part 11 compliance is essential for those FDA regulated companies that wish to use electronic quality records and electronic signatures in place of. The FDA regulation Title 21 CFR Part 11 sets the criteria under which the FDA considers electronic records, electronic signatures, and handwritten signatures. Issued by the FDA (Food & Drug Administration) in , the 21 CFR Part 11 final rule is intended to permit the widest possible use of electronic technology.
|Published:||17 August 2015|
|PDF File Size:||1.66 Mb|
|ePub File Size:||37.70 Mb|
Part 11 applies to all FDA program areas, but does not mandate electronic recordkeeping. Part 11 describes the technical and procedural requirements that must be met if a person chooses to maintain records electronically and use electronic signatures.
Part 11 applies to those records required by an FDA predicate rule and to signatures required by an FDA predicate rule, as well as signatures that are not required, but appear in required records.
Part 11 was fda 21 cfr part 11 in concert with industry over a period of six years. Virtually all of the rule's requirements had been suggested by industry comments to a July 21, Advance Notice of Proposed Rulemaking at 57 FR In response to comments to an August fda 21 cfr part 11, Proposed Rule at 59 FR the agency refined and reduced many of the proposed requirements in order to minimize the burden of compliance.
The final rule's provisions are consistent with an emerging body of federal and state law as well as commercial standards and practices. Most food manufacturers are not otherwise explicitly required to keep detailed records, but electronic documentation kept for HACCP and similar requirements must meet these requirements.
Understanding 21 CFR Part 11
Broad fda 21 cfr part 11 of the regulation have been challenged as "very expensive and for some applications almost impractical",  and the FDA has stated in guidance that it will exercise enforcement discretion on many parts of the rule.
In addition, qualification guidelines for Microsoft Azure and Microsoft Office provide a detailed explanation of how Microsoft audit controls correspond to the requirements of CFR Title 21 Part 11, guidance for implementing an FDA qualification strategy, and a description of areas of shared responsibility.
Download the Azure FDA 21 qualification guide Microsoft in-scope cloud services Although there is no certification for complying with CFR Title 21 Part 11, the following Fda 21 cfr part 11 enterprise cloud services have undergone independent, third-party audits which may help customers in their compliance efforts.
Government detailed list Office and Office U.
What is FDA 21 CFR Part 11? | Eurotherm Life Sciences
MasterControl also creates an audit trail of any captured document. MasterControl requires users to enter two passwords to approve any type of document collaboration.
The fda 21 cfr part 11 password is the login password and the second password is an approval password. FDA 21 CFR Part 11 compliance dictates that all system users have the training necessary to perform their assigned tasks and projects.
MasterControl makes training easy by streamlining the delivery of training tasks, the delivery of online training exams, the grading of exams, training follow-ups, escalations and training reports.