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Compliance
FDA electronic records & signatures

21 CFR Part 11

FDA requirements for electronic records and signatures.

Overview

What it is, in plain English.

21 CFR Part 11 sets the FDA's requirements for electronic records and electronic signatures to be considered trustworthy and equivalent to paper. It applies across pharma, biotech, medical devices, clinical trials, and any GxP system where data supports a regulatory submission. Lyra validates systems, designs Part 11-compliant controls, and produces the documentation FDA inspectors expect under a CSV / CSA approach.

21 CFR Part 11 compliance for life sciences and FDA-regulated environments — covering electronic records, electronic signatures, and audit trails.

Who needs it

Built for organizations that have to get this right.

  • Pharmaceutical and biotech manufacturers

  • Medical device companies (with overlapping QSR / 21 CFR 820 scope)

  • Clinical trial sponsors, CROs, and eClinical platform providers

  • Contract manufacturers and labs operating under GxP

Our approach

How we get you audit-ready and keep you there.

We don't drop policy templates and disappear. We design controls, implement them in your environment, prepare every artifact, and walk with you through the audit — then operate the program after certification so you stay compliant year over year.

  1. 01

    System Inventory & Risk

    We inventory GxP systems, identify Part 11 in scope vs. out, and apply a risk-based CSA approach (per FDA Draft Guidance).

  2. 02

    Validation Strategy

    We author the Validation Plan, URS, FRS, design specs, and risk assessments — calibrated to the system's GxP impact.

  3. 03

    Testing & Documentation

    IQ / OQ / PQ protocols and execution, traceability matrix, and Part 11 control assessment (audit trails, e-sigs, access controls, record integrity).

  4. 04

    Inspection Readiness

    We prepare you for FDA inspection — closing CAPAs, organizing the validation summary report, and rehearsing for the inspector's questions.

Key controls

What's actually in scope.

  • Validated systems with documented IQ/OQ/PQ

  • Secure, computer-generated, time-stamped audit trails

  • Electronic signature components (unique ID, password, biometric, etc.)

  • Record retention and protection for the full FDA-mandated period

  • Operational and procedural controls — training, change control, deviation management

  • Open vs. closed system controls per Part 11.30

Deliverables

What you walk away with.

  • Validation Plan, URS, FRS, IQ/OQ/PQ protocols and reports

  • Part 11 assessment per system

  • Audit trail and e-signature configuration evidence

  • Validation Summary Report

  • Inspection-ready binder and SME briefing

Timeline

Per-system validation: 6–16 weeks depending on complexity. Enterprise Part 11 program: 6–12 months.

Questions we hear

Straight answers to the real questions.

What is CSA and how is it different from CSV?
Computer Software Assurance (CSA) is FDA's modern, risk-based approach that emphasizes critical thinking and unscripted testing over exhaustive documentation. We apply CSA where the system is low-risk and full CSV where it isn't.
Do we need to validate cloud / SaaS systems?
Yes — but you can leverage the vendor's qualification documentation. We perform vendor assessments, gap analysis, and the residual validation activities that fall to you as the regulated user.
Are 483s / Warning Letters about Part 11 still common?
Very. Audit trail gaps, shared logins, and uncontrolled spreadsheets remain the most-cited Part 11 issues in FDA inspections every year.
Talk to a 21 CFR Part 11 expert All frameworks

Other frameworks we support

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