Frameworks · Sector & GxP
21 CFR Part 11 compliance, run as a living system
21 CFR Part 11 is the US FDA's rule for electronic records and electronic signatures, defining the controls under which electronic records are considered trustworthy and equivalent to paper.
Who it applies to
Pharmaceutical, biotechnology, medical device and other FDA-regulated organisations maintaining electronic records or signatures.
What it demands
Validation
Systems validated for accuracy, reliability and consistent intended performance.
Audit trails
Secure, computer-generated, time-stamped audit trails for record changes.
Record protection
Records protected and retrievable throughout the retention period.
Electronic signatures
Signature manifestation, linking and identity verification controls.
How Compli-Once runs it
- 1
Part 11 requirements modelled with the same control and evidence tooling as your security frameworks.
- 2
Validation reports and audit-trail reviews live in the vault with expiry tracking.
- 3
Findings from inspections run on the audit and CAPA machinery, closing with evidence.
What you already satisfy
21 CFR Part 11 overlaps with frameworks you may already run. The crosswalk quantifies existing coverage on day one, before you plan a single task.
Implement once, satisfy many
In a representative demonstration environment, 61% of a newly adopted regulatory framework was already satisfied by the existing ISO 27001 programme.
Illustrative, computed live per tenant in the platform.
Frequently asked questions
What is 21 CFR Part 11?
It is the US FDA's rule defining when electronic records and electronic signatures are trustworthy and equivalent to paper. It requires system validation, computer-generated audit trails, record protection and signature controls.
Which other GxP frameworks are supported?
EU GMP Annex 11, WHO GMP and PIC/S are in the library with the same tooling, and custom site-specific requirements can be authored as frameworks.
Can validation evidence be shared across systems?
Yes. Shared infrastructure validation is stored once and linked to every record-system control it supports.
How are inspection findings managed?
As findings with severity, owners and due dates on the audit module, closing with evidence. Repeat findings are tracked so systemic issues surface.