Online Documentation: EZ-MES Quality Compliance
21 CFR Part 11
In this page we will look into the compliance of EZ-MES Manufacturing Execution
System with Part 11 of the 21CFR.
Some short facts:
- Aka: 'Title 21 CFR Part 11' or 'Part 11'
- CFR stands for Code of Federal Regulations
- FDA Guideline on electronic records and electronic signatures
- Defines criteria under which electronic records and electronic signatures are considered
to be trustworthy, reliable and equivalent to paper records.
21 CFR Part 11 requires to implement controls including:
- Audits
- System validations
- Audit Trails
- Electronic Signatures
- Documentation for software and systems involved in processing electronic data
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