18 min readUpdated Jan 2026
21 CFR Part 11 Compliance Guide for Laboratories
FDA's regulation for electronic records and signatures. Here's what it actually requires and how to configure your LIMS for genuine compliance.
Core Part 11 Requirements (§11.10)
(a)
Validation — Systems validated for accuracy, reliability, and ability to discern invalid records
(b)
Readable Copies — Generate accurate, complete copies in human-readable and electronic form
(c)
Record Protection — Records protected throughout retention period with ready retrieval
(d)
Access Control — Limit system access to authorized individuals
(e)
Audit Trails — Secure, computer-generated, time-stamped trails for all changes
(f)
Operational Checks — Enforce permitted sequencing of steps and events
(g)
Authority Checks — Ensure only authorized individuals can sign or access data
(h)
Device Checks — Validate data input and operational instructions
(i)
Training — Personnel with appropriate education and training
(j)
Accountability Policies — Written policies for electronic signature accountability
Electronic Signature Requirements
Signature Manifestation (§11.50)
- • Printed name of signer
- • Date and time of signature
- • Meaning (review, approval, responsibility)
Signature Linking (§11.70)
- • Linked to respective records
- • Cannot be excised or copied
- • Cannot be transferred to falsify
LIMS Part 11 Capabilities
Audit Trails
Automatic logging, secure storage, complete change history, accurate timestamps
E-Signatures
Meaning required, dual verification, permanent linking, manifestation display
User Management
Unique accounts, role-based permissions, password policies, account lockout
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