21 CFR Part 11 / Annex 11 Compliance

Electronic records and signatures must meet 21 CFR Part 11 and EU GMP Annex 11 to be acceptable to regulators — and gaps here undermine the trustworthiness of everything a system produces. PharmExpert assesses your systems against both frameworks and remediates the gaps: audit trails, electronic signatures, access controls, record retention and system validation.

Our assessment is system-by-system and evidence-based. We examine whether audit trails are not only enabled but configured correctly and actually reviewed; whether electronic signatures meet the controls the regulations require; and whether access rights, security and segregation of duties hold up in practice rather than on paper.

We then risk-rank the gaps across your system inventory and deliver a prioritized remediation plan, so effort goes first to the systems and deficiencies that carry the most risk. Remediation covers both technical fixes and the procedures and governance around them.

Because most organizations operate in both US and EU markets, we harmonize the two frameworks so a single, well-designed control set satisfies both — avoiding duplicated, conflicting controls. The outcome is electronic records and signatures that regulators will accept, verified and documented.