These regulations require clear applicability decisions, controlled operation and defensible evidence for electronic records and signatures. We design the control model and evidence narrative that stands up under inspection.
In cloud and SaaS environments, the regulated organisation remains accountable regardless of who manages the infrastructure. Governance succeeds when responsibilities and evidence are explicit.
Based on a genuine engagement. Details are anonymised, and in some cases composited, to protect client confidentiality.
A global CRO migrating to a new electronic data capture platform needed to confirm that the system's electronic signature and audit trail configuration met both 21 CFR Part 11 and EU Annex 11 requirements across a multiregional clinical trial programme. The migration timeline was fixed and the compliance assessment had not been scoped.
The vendor's compliance documentation was written generically and did not address the organisation's specific configuration, defined user roles or intended use. There was no clear mapping between regulatory requirements and implemented controls, leaving an unresolved compliance gap that QA and regulatory affairs were not in a position to close internally.
A Part 11 and Annex 11 applicability assessment was conducted against the organisation's specific configuration and intended use. Vendor documentation was reviewed, annotated and supplemented. A configuration-specific compliance matrix was produced, covering audit trail, electronic signatures, access controls and record retention, together with a validated signature workflow record.
The compliance package was accepted by QA and regulatory affairs without revision. The platform was released to production with a complete, auditable electronic records governance record in place and no outstanding compliance questions.
Book a call to discuss your applicability position and what a proportionate evidence pack needs to look like.