503B Compliance
21 CFR Part 11 for electronic batch records
In compounding, compliance is not an afterthought — it is your license to operate. When a 503B outsourcing facility replaces paper batch records with an electronic system, 21 CFR Part 11 governs how those records and signatures must work. Clarix was engineered around Part 11 control objectives from day one, so your team can validate the system for its intended use.
What Part 11 actually requires
The core message is straightforward: if you use an electronic system to create, modify, or sign a regulated record, that system must help ensure the record is trustworthy, reliable, and non-repudiable. Every action must be attributable to a verified individual, every record must be tamper-evident, and every electronic signature must carry the same legal weight as a handwritten one.
- § 11.10 — Controls for closed systems:audit trails, authority checks, and secure record retention for systems that create, modify, or maintain electronic records.
- § 11.50 — Signature manifestations:every e-signature must show the signer's printed name, the date and time, and the meaning of the signature (approval, check, release).
- § 11.300 — Controls for identification codes/passwords:unique user IDs, periodic checks, and controls to prevent reuse of compromised credentials.
How Clarix embeds Part 11 into daily operations
Dual e-signatures on every critical action (§ 11.50)
Batch release, verification, and disposition steps capture two independent PIN-based signatures with strict role gates — for example, a compounding technician and the pharmacist-in-charge. Each signature records signer name, timestamp, and meaning.
Immutable audit trail (§ 11.10)
UUID v7 time-sortable records. Secure, computer-generated, timestamped audit entries track every modification automatically — who did what, when, from which device, and what changed. Records are not altered or deleted in normal workflow.
Turnkey validation package
Complete IQ/OQ/PQ protocols matching the Clarix source code version cut validation time from months to days — and give inspectors the documentation they expect.
Built to survive your next FDA 483 inspection
Inspectors focus on audit trail completeness, signature authenticity, access control, and validation evidence. Clarix makes those the default path in the product: audit trails capture automatically, e-signatures are required at lifecycle gates, and the documentation trail is ready before the inspector asks.
See the full engineering detail in our 21 CFR Part 11 documentation and the e-signatures & audit trail guide. Ready to see it in action? Request a pilot.
Frequently asked questions
What is 21 CFR Part 11?
21 CFR Part 11 is the FDA regulation governing electronic records and electronic signatures used in place of paper records and handwritten signatures. It applies when an electronic system creates, modifies, or signs regulated records, such as batch records in a 503B compounding facility.
Does Clarix support 21 CFR Part 11 electronic signatures?
Yes. Clarix captures dual e-signatures with signer name, timestamp, and meaning (§ 11.50) on critical batch actions, maintains an immutable, computer-generated, time-stamped audit trail (§ 11.10), and enforces role-based access controls (§ 11.300).
Does Clarix include validation documentation?
Clarix ships a turnkey validation package with IQ/OQ/PQ protocols matching the Clarix source code version, cutting validation time from months to days. Your organization validates the system for its intended use.
Is Clarix 'Part 11 certified'?
No software can be 'Part 11 certified.' Clarix is designed to support Part 11 control objectives, and your organization validates the system for its intended use. Clarix provides the documentation and controls to make that validation practical.