Electronic Records And Electronic Signatures (21 CFR 11)

Bob's thoughts on the Electronic Records And Electronic Signatures 21 CFR 11 regulation and its interpretation.

Electronic Record and Electronic Signature final rule is having a major impact on the way that companies undertake validation of computerised systems and attempt to upgrade their existing legacy systems. Here are collected Bob's thoughts on the 21 CFR 11 regulation and its interpretation.

Electronic Records

Various articles about electronic records, including: E-Sign On The Bottom Line, How Raw Are Your Data, How Raw Are Your Data - 2000, Selecting A Part 11 Compliant System, Containment Of The Part 11 Problem and Computer (In) Security.

21 CFR 11 Controls

Have You Tested Your Device? Remember GIGO (Garbage In, Garbage Out)? A look at a wider interpretation of what constitutes a device check.

Preservation Of Electronic Records

Backup Your Data Or Backs To The Wall. How Long Is Long-Term Archiving?

Electronic Signatures

Electronic Signatures And Logical Security, Biometrics: The Password You'll Never Forget, Digital Signatures, Exploiting The Benefits Of Electronic Signatures and Systems Not Applications.

Time And Date

Discussions about the importance of accurate time and date stamps for trustworthy and reliable electronic records and signatures.

Part 11 Scope And Application Guidance

Part 11 Is Dead, Long Live Part 11.