Part 11 applicability checker: does Part 11 apply to your record?
Part 11 reaches a record only when an FDA rule requires it or it goes to FDA, and only when it is kept in electronic form in place of paper. Answer three questions about one record to see where it lands, with the reasoning and the cite for each step. It reads the regulation and FDA’s 2003 Part 11 scope guidance, nothing else.
The tool
Click any answer to change it. Pre-filled with a realistic example: HPLC results a QC lab keeps for batch release.
Result for: HPLC assay results for batch release
Part 11 applies
Why
- § 11.1(b)A predicate rule requires the record, so Part 11 reaches it once it is kept in electronic form.
- 2003 guidance, III.B.2Paper copies exist, but you rely on the electronic record to perform regulated activities, so it is a Part 11 record.
- 2003 guidance, III.B.2The electronic signature stands in for a signing the predicate rule requires, so it is a Part 11 signature: Subpart C applies, plus manifestation (§ 11.50) and linking (§ 11.70).
What FDA said it enforces (2003 guidance)
- Enforced
- § 11.10(d) access, (f) operational checks, (g) authority checks, (h) device checks, (i) training, (j) signature accountability policy, systems documentation controls, and the matching § 11.30 controls. Signatures, enforced in full: §§ 11.50, 11.70, 11.100, 11.200 and 11.300.
- Discretion
- § 11.10(a) validation, § 11.10(b) copies, § 11.10(c) retention, § 11.10(e) and (k)(2) audit trail, and the matching § 11.30 controls. The predicate rule's own validation, audit-trail, retention and inspection requirements still apply.
What it checks
Part 11 is narrower than most vendor brochures suggest. It reaches a record only when an FDA rule already requires that record (a predicate rule) or the record is submitted to FDA, and only when the record lives in electronic form in place of paper. The checker asks those questions in order, then a third about signatures, because a record can fall under Part 11 while its signatures do not.
There are four answers. Part 11 applies: the electronic record and its electronic signatures both fall under the rule. Part 11 applies to the records only: the controls for electronic records apply, but there is no Part 11 signature. Part 11 applies, except Subpart C: a handwritten signature is captured onto the electronic record, so manifestation (§ 11.50) and linking (§ 11.70) apply but the electronic-signature rules in §§ 11.100 to 11.300 do not. Outside Part 11: the predicate rule still governs the record, Part 11 does not.
For the rule in full, read what 21 CFR Part 11 covers and who it binds, then each requirement section by section.
How to use this checker
- 01Name one record, not a system. A LIMS holds records that fall on both sides of the line. Run the check per record type: results, reviews, logbooks, training sign-offs.
- 02Find the predicate rule. Name the part and section that requires the record (§ 211.194 for lab records, § 58.130 for GLP data, § 820.35 for device records). If you cannot name one, the record is probably outside Part 11.
- 03Say which version people rely on. Watch what happens on an ordinary day. If reviewers approve from the screen, the electronic record is the one relied on, whatever the SOP says about printouts.
- 04Say how the record is signed. Separate the signings a rule requires (approved, reviewed, verified) from approval clicks your own workflow adds.
- 05File the decision. Copy the result into the SOP or system specification that covers the record, as the 2003 guidance recommends.
When the answer is that Part 11 applies, the next question is which controls: decide whether the system is open or closed with the open vs closed system check, then mark each control in the Part 11 compliance checklist. Signed records go through the signature manifestation check.
Worked examples
Seven records from a small drug and GLP lab, each run through the checker. The answers come from the tool itself.
| Record | 1. Why it exists | 2. Form | 3. Signing | Answer |
|---|---|---|---|---|
| HPLC assay results in a chromatography data system; printouts are filed, but release is decided on screen; analyst and reviewer sign in the system§ 211.194 | Required by a rule | Both, rely on electronic | E-signature, required | Part 11 applies |
| GLP study observations typed straight into an electronic notebook, no paper, no signing per entry§ 58.130(e) | Required by a rule | Electronic only | Not signed | Part 11 applies to the records only |
| Executed batch record on a tablet, each step initialled with a stylus§ 211.188 | Required by a rule | Electronic only | By hand onto the record | Part 11 applies, except Subpart C |
| SOP drafted in a word processor, printed and approved in ink; the signed paper is the controlled copy | Required by a rule | Both, rely on paper | Ink on paper | Outside Part 11 |
| Paper batch record signed in ink, then scanned and emailed to the client | Required by a rule | Paper only | Ink on paper | Outside Part 11 |
| Working spreadsheet used to lay out a table for a submission; the source data live in the LIMS | Feeds a submission only | Electronic only | Not signed | Outside Part 11 |
| Validation project tracker in a shared task tool | Not required | Electronic only | E-click, not required | Outside Part 11 |
The spreadsheet row is the one teams most often get wrong in both directions. A spreadsheet that only lays out a submission table is outside, but one that calculates reportable results can be a record the predicate rule requires: see Excel spreadsheets under Part 11.
Three misreadings to avoid
Misreading: “Part 11 applies to every electronic record”
It does not. § 11.1(b) reaches records kept under an FDA records requirement and records submitted to FDA. The 2003 guidance adds that records not required by a predicate rule, even when kept electronically, “are not part 11 records”.
Misreading: “Outside Part 11 means no audit trail or validation”
The predicate rule still applies. A GLP lab’s automated data still needs the person entering it identified and changes made “so as not to obscure the original entry” (§ 58.130(e)), with or without Part 11. See what a GxP audit trail must capture.
Misreading: “Buying Part 11 software settles the question”
Part 11 binds the people who use a system, and FDA keeps no list of certified software. Whether a record is in scope is your decision about your records; the vendor cannot make it for you.
Where the rule says so
§ 11.1(b), scope
Part 11 “applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth in agency regulations”. It “does not apply to paper records that are, or have been, transmitted by electronic means”.
2003 guidance, section III.B.1, narrow interpretation
Where printouts meet the predicate rules and are relied on, “the use of computer systems in the generation of paper records would not trigger part 11”. FDA recommends you document the decision “in a Standard Operating Procedure (SOP), or specification document”.
2003 guidance, enforcement
FDA said it does not intend to enforce the Part 11 validation, audit trail, record retention and record copying requirements, but “We will enforce all predicate rule requirements, including predicate rule record and recordkeeping requirements.” The signature sections stay enforced. Device makers should read this beside the FDA QMSR, which removed the § 820.70(i) cite the guidance uses.
Sources
- 21 CFR Part 11, Electronic Records; Electronic Signatures (up to date as of 2026-10-20), eCFRread 2026-10-22
- Part 11, Electronic Records; Electronic Signatures — Scope and Application (2003), FDAread 2026-10-22
- 21 CFR Part 58, Good Laboratory Practice for Nonclinical Laboratory Studies, eCFRread 2026-10-22
- 21 CFR Part 211, CGMP for Finished Pharmaceuticals, eCFRread 2026-10-22