BY NEURABYTE
FRAMEWORKS/OTHER/21 CFR PART 11
P11
OTHER · US FDA

21 CFR Part 11

Electronic records and electronic signatures in FDA-regulated work.

Part 11 sets the conditions under which FDA accepts electronic records and signatures as equivalent to paper. It requires validated systems, secure and computer-generated audit trails, authority checks, and signatures linked to their records. It applies to pharma, biotech, medical devices, food, and clinical research.

AT A GLANCE
ISSUERUS FDA REGIONFDA-regulated industries CATEGORYOther CROSSWALKVersioned mapping onto the 15-control registry
EVIDENCE, NOT CERTIFICATION
01. WHO IT APPLIES TO

Is this one yours?

01Life sciences companies keeping GxP records electronically
02Clinical research organizations and sites
03Agents that create, modify, or approve regulated records
02. KEY REQUIREMENTS

The parts of 21 CFR Part 11 that touch what agents do.

§11.10(e) Audit trails
Secure, computer-generated, time-stamped audit trails record the date and time of operator entries and actions, without obscuring previous values.
§11.10(g) Authority checks
The system checks that only authorized individuals can use the system, sign records, or perform operations.
§11.50 Signature manifestations
Signed records show the signer's name, date and time, and meaning of the signature.
§11.70 Signature linking
Signatures are linked to their records so they cannot be excised, copied, or transferred.
03. HOW LORE MAPS TO IT

Enforcement controls, read against the requirement.

These controls exist because the platform needs them to run safely. The crosswalk reads their signed evidence against 21 CFR Part 11. Where there is no evidence, the report says gap.

LORE CONTROL 21 CFR PART 11 REFERENCE
Signed, hash-chained receipts§11.10(e), §11.70
Blocking authorization gate§11.10(g)
Maker–checker approval§11.50, §11.200 accountability
Context disclosure record§11.10(e) previous values preserved
Illustrative references. The shipped crosswalk carries exact clause citations, its version, and the review date.
04. OUT OF SCOPE

What Lore will not claim.

System validation (§11.10(a)) is performed by you against your intended use.
Signature legal certification to FDA (§11.100(c)) is a company filing.
05. QUESTIONS
Does a receipt count as an electronic signature?
A receipt records an approval by an identified checker with time and meaning. Whether it is a Part 11 signature depends on your validation and SOPs.
What about GxP validation of Lore?
We provide the documentation set to support your validation. The validation itself is yours.
Is this the same as Annex 11?
EU Annex 11 is the parallel GMP guideline. The crosswalk notes where they differ.
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21 CFR PART 11 · EARLY ACCESSEVIDENCE COLLECTED ONCE

Start building the record your auditor will read.

Every receipt Lore signs today is evidence for 21 CFR Part 11 tomorrow. Turn the crosswalk on when you are ready; nothing needs re-collecting.

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