21 CFR Part 11
The US FDA regulation for electronic records and electronic signatures in regulated industries.
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21 CFR Part 11 is the part of the US Code of Federal Regulations in which the FDA defines when electronic records and signatures are equivalent to paper. Anyone producing for the American market in pharma, biotech, or medical devices deals with it. The European counterpart for computerized systems is EU GMP Annex 11.
For label management the requirements come down to three things. First, an audit trail: every creation, change, and approval of a label template is recorded automatically and immutably. Second, access control: only authorized people can change or approve, with unique accounts. Third, electronic signatures demonstrably tied to one person.
Important to know: software alone does not make you compliant. The system must provide the functions (as Loftware Cloud Compliance does out of the box), but the setup, procedures, and validation remain the responsibility of your quality department.
Frequently asked questions — 21 CFR Part 11
What does 21 CFR Part 11 regulate?
It defines when electronic records and electronic signatures are equivalent to paper for the FDA.
What is the European counterpart?
For computerised systems that is EU GMP Annex 11.
Does software make me compliant by itself?
No. The software must provide the functions (audit trail, access control, electronic signatures), but configuration, procedures and validation remain the responsibility of your quality department.
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