21 CFR Part 11 and Business Central — Compliance Checklist

21-cfr-part-11 · fda · electronic-records · gxpMarch 26, 2026

FDA 21 CFR Part 11 establishes requirements for electronic records and electronic signatures in regulated activities subject to FDA jurisdiction. For pharmaceutical, medical device, and biotech manufacturers using Business Central, Part 11 compliance is a prerequisite for US market access and FDA inspection readiness.

Part 11 applies when electronic records are used to meet FDA requirements that would otherwise be satisfied by paper records. In a Business Central context, this typically includes batch manufacturing records, quality inspection results, deviation and CAPA records, change control approvals, and equipment calibration records.

Audit trail configuration

Business Central SaaS is a closed system — access is controlled through Entra ID. The audit trail requirement is operationally most significant. Business Central's Change Log must be configured to capture all Part 11-relevant data entries with user identity, timestamp, and the nature of the change. The Change Log must be protected from deletion and alteration by any user including system administrators.

Electronic signature requirements

Part 11 requires that electronic signatures are unique to one individual and not reused or reassigned. Business Central's approval workflow engine supports compliant controls: each approval step requires authenticated authorisation via Entra ID, and the approval record captures user identity and timestamp. For compliance, workflows must be configured so that re-authentication is required for signature actions, the meaning of the signature is captured, and signed records are protected from subsequent modification.

Practical compliance checklist

  • System validation with complete documentation package
  • Change Log configured and protected for all Part 11-relevant tables
  • Entra ID as identity provider with no shared logins
  • Approval workflows capturing identity, timestamp, and reason for signature
  • Current system documentation and SOP references maintained
  • Personnel training records current and accessible

Download the 21 CFR Part 11 compliance checklist for Business Central as a PDF using the link below.

Download Guide