FDA 21 CFR Part 11 & GxP compliance

Effective date: July 12, 2026. Informational — compliance is achieved by your validated use, not by the software alone.

What Part 11 is

21 CFR Part 11 is the US FDA regulation governing electronic records and electronic signatures in regulated environments (GxP: Good Laboratory/Manufacturing/Clinical Practice). The EU equivalent is EudraLex Annex 11. Both require that electronic records be trustworthy, attributable, and secure — often summarized by the ALCOA+ data-integrity principles (Attributable, Legible, Contemporaneous, Original, Accurate, + Complete, Consistent, Enduring, Available).

Shared responsibility

Part 11 compliance is shared: NextELN provides the technical controls; you (the regulated organization) provide the procedural controls — validation, SOPs, training, and oversight. No ELN is "Part 11 certified" out of the box; compliance is achieved through your validated, controlled use.

Controls NextELN provides

Part 11 requirement	NextELN capability
Audit trail (who/what/when)	Time-stamped, attributable audit logs of record changes
Record integrity / immutability	Immutable version history; archived prior revisions
Electronic signatures	E-signatures with signer identity + meaning; witnessing
Access controls	Unique user accounts, role-based permissions, per-workspace isolation, optional IP restriction
Data attributability	Created-by / updated-by / timestamps on records
Copies for inspection	Export/archive to human-readable + machine-readable formats
Authentication	Signed sessions; password controls

Your responsibilities (to reach Part 11 compliance)

• Validate the system for your intended use (e.g. IQ/OQ/PQ) and keep validation records.
• Maintain SOPs for account management, e-signatures, audit-trail review, and change control.
• Ensure signatures are linked to records and manifest the signer's name, date/time, and meaning.
• Control user provisioning/de-provisioning and periodic access reviews.
• Train users and retain training records.

GxP, GLP/GMP/GCP, and beyond

The same capabilities support GLP/GMP/GCP workflows and EU Annex 11. For HIPAA (if you store PHI), contact us about a Business Associate Agreement — PHI is not supported by default. We can provide documentation to assist your validation effort.

Questions or a validation/compliance package request: support@nexteln.com.