Compliance audits for electronic records and electronic signatures under FDA 21 CFR Part 11, for regulated life-sciences and medical-device environments.
For FDA-regulated organisations, Part 11 governs how electronic records and signatures must be controlled to be considered trustworthy and equivalent to paper.
We assess your systems and processes against Part 11 — covering validation, audit trails, access controls and signature requirements — and identify what’s needed to satisfy regulatory expectations.
Evidence that systems perform as intended.
Secure, time-stamped, tamper-evident logging.
Limiting system access to authorised users.
Uniqueness, binding and signature controls.
Accurate, complete and retrievable data.
The profiles that typically call on this service.
Life-sciences organisations selling into the US must demonstrate that electronic records and signatures meet 21 CFR Part 11 alongside the underlying predicate rules; independent assessment evidences data integrity to the FDA.
A staged approach built to deliver a defensible outcome.
Identifying the GxP systems and electronic records in scope.
Mapping requirements to the predicate rules and 21 CFR Part 11.
Testing electronic records and electronic-signature controls.
Reviewing audit trails, access controls and data integrity.
Assessing computer-system validation evidence.
A report with findings and a remediation plan.
The work is mapped to the standards and rules that apply to you.
What to have in place before we begin.
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