Best ELN software for Part 11 labs: six notebooks read against the rule
Published , reviewed
Verdict
- Best overall
- Labguru ELNThe one notebook here whose own help pages describe all three signature rows: the signer's and witness's names and times under the entry, the link to the record, and the signing step (single sign-on accounts confirm without re-entering a password, so check that set-up). Its audit trail, copies and role checks read as verified; it publishes no Annex 11 statement.
- Best for a small lab
- SciNote PremiumIts Premium plans add a Part 11 module with e-signatures, witnessing, audit trails and user management, and its help pages describe the signing step, the audit trail and user roles. The signature display and the record link are stated, not described, so test those two.
- Best for a separate GxP space
- Benchling NotebookBenchling Validated Cloud is a separate validation-ready environment that comes with validation documentation. The audit trail, copies and reviewer permissions read as verified; every signature row is stated only.
Fig. 01A notebook entry becomes a Part 11 record when a predicate rule requires it (a GLP study record, a drug lab record with “complete data derived from all tests” under § 211.194) or when you keep it electronically and rely on it. From then on, four moments carry the weight: signing, witnessing, locking and exporting. We read the 6 notebooks below on their makers' own pages against those moments.
Samples, specifications and released results belong to a LIMS, which we compare separately in LIMS for biotech and Part 11 labs; how a LIMS differs from an ELN draws the line between the two. Signing PDFs such as SOPs and protocols is covered in the Part 11 e-signature software comparison.
What Part 11 asks of a notebook entry
Part 11 has no section on notebooks. It has rules for records and rules for signatures, and an entry meets them in a fixed order. Read the five states first, then what the rule says at each step.
- 01DraftAuthor writes and edits§ 11.10(e)
- 02SignedAuthor signs, meaning authorship§ 11.50, § 11.200(a)
- 03WitnessedA second person signs, own meaning§ 11.50, § 11.10(g)
- 04LockedSignatures stay bound to the text§ 11.70
- 05ExportedA full copy for an inspector§ 11.10(b)
Scroll sideways for the full table
| Moment | The rule's words | What it means in a notebook |
|---|---|---|
| Writing and changing the entry§ 11.10(e) | “secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records” | The rule speaks of entries that create, modify or delete a record, not only of changes after signing. Ask where the notebook's trail starts. |
| Signing as author§ 11.50(a), (b) | “(1) The printed name of the signer; (2) The date and time when the signature was executed; and (3) The meaning (such as review, approval, responsibility, or authorship)” | All three must appear in any human readable form, so the PDF has to carry them, not only the screen. |
| Witnessing§ 11.10(g) | “authority checks to ensure that only authorized individuals can use the system, electronically sign a record” | Witness rights are granted by role, and the witness signature carries its own name, time and meaning under § 11.50. |
| Executing each signature§ 11.200(a)(1) | “Employ at least two distinct identification components such as an identification code and password.” | First signing in a session uses every component; later ones in the same session at least one private component. A new session starts over. |
| Locking after signing§ 11.70 | “linked to their respective electronic records to ensure that the signatures cannot be excised, copied, or otherwise transferred to falsify an electronic record by ordinary means” | Part 11 never says lock. It asks that a signature cannot move onto other content, and that a later change does not obscure the signed text. |
| Exporting for inspection§ 11.10(b) | “accurate and complete copies of records in both human readable and electronic form” | A PDF is half the answer. The electronic form, the attachments and the entry's trail belong to the same request. |
Common misreading
“Signed entries are locked” is not the test. If an administrator can unlock an entry and the edits that follow leave no trail line, that fails § 11.10(e); if the old signature still shows on changed text, that is the § 11.70 question. Ask what an unlock writes to the trail, and what the signature block shows afterwards.
Takeaway
Judge a notebook by the signed, witnessed PDF it exports and the trail behind it. If those two hold up, most of the rest follows. For what a trail must capture, see what an audit trail is in GxP.
Six notebooks, requirement by requirement
Rows run in the order an entry meets them. A status word says how far each vendor's own documentation goes; it is not a score, and stated is not a failure. It means the claim is yours to test.
Scroll sideways for all vendors
| Requirement | Benchling Notebook | Signals Notebook | Labguru ELN | SciNote Premium | SciSure ELN | CDD Vault ELN |
|---|---|---|---|---|---|---|
| Signature shows name, date and time, and meaning§ 11.50 | stated | stated | verified | stated | stated | stated |
| Signature linked to its record so it cannot be moved§ 11.70 | stated | stated | verified | stated | verified | stated |
| Two distinct components to sign§ 11.200(a) | stated | verified | verified | verified | verified | stated |
| Access and authority checks by role§ 11.10(d), (g) | verified | stated | verified | verified | verified | verified |
| Secure, computer-generated, time-stamped audit trail§ 11.10(e) | verified | verified | verified | verified | stated | verified |
| Audit trail kept as long as the record§ 11.10(e) | stated | stated | stated | stated | not stated | stated |
| Accurate, complete copies for inspection§ 11.10(b) | verified | verified | verified | stated | verified | verified |
| Validation documentation to support the customer's own validation§ 11.10(a) | verified | verified | verified | verified | not stated | not stated |
| Open-system controls: encryption, digital signatures§ 11.30 | stated | not stated | not stated | not stated | not stated | stated |
| EU Annex 11 statementEU GMP Annex 11 | stated | stated | not stated | stated | not stated | not stated |
verified: read on the vendor's own documentation on 2026-10-22. stated: the vendor claims it; we did not check. not stated: nothing published.
- Signature display (§ 11.50). Only Labguru ELN describes the name, time and meaning on the entry in its own help pages. Ask every other vendor for a screenshot of a signed PDF.
- Signature linked to the entry (§ 11.70). Verified for Labguru ELN and SciSure ELN. That row is where a witnessed notebook stands or falls, so test it in the demo.
- Trail kept as long as the record. 5 of 6 claim it without describing it. 1 of 6 publish nothing on it. Ask in writing, because your predicate rule sets the period.
- Validation documents (§ 11.10(a)). Not stated for SciSure ELN and CDD Vault ELN. You can still validate those yourselves; plan for it in your computer system validation.
Vendor by vendor
Each card carries the six rows that decide whether a signed, witnessed entry holds up, with the vendor's own Part 11 page and the date we read it.
Benchling Notebook
ELN- What it is
- Benchling Notebook is a cloud-based electronic lab notebook where scientists document experiments, samples and results in one shared system. For GxP work Benchling offers Benchling Validated Cloud, a separate validation-ready environment with e-signature controls, audit trails and user access management.
- Who it fits
- Biotech and pharma R&D teams that want a separate validated environment for their GxP work.
| Requirement | Status |
|---|---|
| Signature shows name, date and time, and meaning§ 11.50 | statedHelp pages describe a signature meaning set per review stage and log the reviewer, time and decision. |
| Signature linked to its record so it cannot be moved§ 11.70 | stated |
| Two distinct components to sign§ 11.200(a) | statedThe help article mentions re-validating login credentials only when single sign-on is enabled. |
| Secure, computer-generated, time-stamped audit trail§ 11.10(e) | verified |
| Accurate, complete copies for inspection§ 11.10(b) | verified |
| Access and authority checks by role§ 11.10(d), (g) | verified |
verified: read on the vendor's own documentation on 2026-10-22. stated: the vendor claims it; we did not check. not stated: nothing published.
Check with the vendor
Some rows above are stated or not stated on Benchling's own pages. Ask Benchling for its validation documentation and test the control in your own validation before you rely on it.
Benchling's own Part 11 pageread 2026-10-22
Signals Notebook
ELN- What it is
- Signals Notebook is a cloud-based electronic lab notebook for biologists and chemists to capture, organize, share and explore data. Revvity Signals offers validation documentation, IQ/OQ deliverables and release-specific reports for customers who validate it.
- Who it fits
- Pharma and biotech chemistry and biology teams running a validated cloud ELN.
| Requirement | Status |
|---|---|
| Signature shows name, date and time, and meaning§ 11.50 | statedAdministrators can set the signing statement shown when a user signs. |
| Signature linked to its record so it cannot be moved§ 11.70 | stated |
| Two distinct components to sign§ 11.200(a) | verifiedPassword re-entry at signing is an administrator setting. |
| Secure, computer-generated, time-stamped audit trail§ 11.10(e) | verified |
| Accurate, complete copies for inspection§ 11.10(b) | verified |
| Access and authority checks by role§ 11.10(d), (g) | stated |
verified: read on the vendor's own documentation on 2026-10-22. stated: the vendor claims it; we did not check. not stated: nothing published.
Check with the vendor
Some rows above are stated or not stated on Revvity Signals' own pages. Ask Revvity Signals for its validation documentation and test the control in your own validation before you rely on it.
Revvity Signals' own Part 11 pageread 2026-10-22
Labguru ELN
ELN- What it is
- Labguru's ELN is a digital lab notebook that helps labs organize research data and collaborate on experiments. It connects with Labguru's LIMS, inventory and equipment tools.
- Who it fits
- Academic, biotech, pharma, QC and contract research labs.
| Requirement | Status |
|---|---|
| Signature shows name, date and time, and meaning§ 11.50 | verifiedThe signer's and the witness's names and times show under the entry title, each marked as signed or witnessed. |
| Signature linked to its record so it cannot be moved§ 11.70 | verified |
| Two distinct components to sign§ 11.200(a) | verifiedAccounts on single sign-on confirm without re-entering a password. |
| Secure, computer-generated, time-stamped audit trail§ 11.10(e) | verified |
| Accurate, complete copies for inspection§ 11.10(b) | verified |
| Access and authority checks by role§ 11.10(d), (g) | verified |
verified: read on the vendor's own documentation on 2026-10-22. stated: the vendor claims it; we did not check. not stated: nothing published.
BioData Inc.'s own Part 11 pageread 2026-10-22
SciNote Premium
ELN- What it is
- SciNote is a cloud-based electronic lab notebook with lab inventory, compliance and team management tools. Its Premium plans include a 21 CFR Part 11 add-on with electronic signatures, electronic witnessing, audit trails and user management.
- Who it fits
- Small regulated labs that want Part 11 features as an add-on to a cloud notebook.
| Requirement | Status |
|---|---|
| Signature shows name, date and time, and meaning§ 11.50 | statedE-signatures come with SciNote's 21 CFR Part 11 add-on on Premium plans. |
| Signature linked to its record so it cannot be moved§ 11.70 | stated |
| Two distinct components to sign§ 11.200(a) | verifiedSingle sign-on accounts verify through their identity provider instead. |
| Secure, computer-generated, time-stamped audit trail§ 11.10(e) | verified |
| Accurate, complete copies for inspection§ 11.10(b) | stated |
| Access and authority checks by role§ 11.10(d), (g) | verifiedSome roles, such as Reviewer, are available only on some plans. |
verified: read on the vendor's own documentation on 2026-10-22. stated: the vendor claims it; we did not check. not stated: nothing published.
Check with the vendor
Some rows above are stated or not stated on SciNote's own pages. Ask SciNote for its validation documentation and test the control in your own validation before you rely on it.
SciNote's own Part 11 pageread 2026-10-22
SciSure ELN
ELN- What it is
- SciSure ELN is an electronic lab notebook for documenting experiments, with sample, inventory and safety tools on the same platform. SciSure was formed by merging eLabNext and SciShield, and its help articles still use the eLabJournal name.
- Who it fits
- Research and biotech labs that want notebook, inventory and safety records in one system.
| Requirement | Status |
|---|---|
| Signature shows name, date and time, and meaning§ 11.50 | statedThe help article shows a time-stamped signature in the experiment header but does not say the name or meaning is shown. |
| Signature linked to its record so it cannot be moved§ 11.70 | verified |
| Two distinct components to sign§ 11.200(a) | verifiedAccounts on LDAP, AD or SSO sign with a two-step verification code instead of a password. |
| Secure, computer-generated, time-stamped audit trail§ 11.10(e) | stated |
| Accurate, complete copies for inspection§ 11.10(b) | verified |
| Access and authority checks by role§ 11.10(d), (g) | verified |
verified: read on the vendor's own documentation on 2026-10-22. stated: the vendor claims it; we did not check. not stated: nothing published.
Check with the vendor
Some rows above are stated or not stated on SciSure's own pages. Ask SciSure for its validation documentation and test the control in your own validation before you rely on it.
SciSure's own Part 11 pageread 2026-10-22
CDD Vault ELN
ELN- What it is
- CDD Vault ELN is an electronic lab notebook for recording experiments, searching entries and collaborating with teams in real time. It sits inside CDD Vault next to its chemical and biological registration tools.
- Who it fits
- Drug discovery teams that already register compounds and biologics in CDD Vault.
| Requirement | Status |
|---|---|
| Signature shows name, date and time, and meaning§ 11.50 | stated |
| Signature linked to its record so it cannot be moved§ 11.70 | stated |
| Two distinct components to sign§ 11.200(a) | stated |
| Secure, computer-generated, time-stamped audit trail§ 11.10(e) | verified |
| Accurate, complete copies for inspection§ 11.10(b) | verified |
| Access and authority checks by role§ 11.10(d), (g) | verified |
verified: read on the vendor's own documentation on 2026-10-22. stated: the vendor claims it; we did not check. not stated: nothing published.
Check with the vendor
Some rows above are stated or not stated on Collaborative Drug Discovery Inc.'s own pages. Ask Collaborative Drug Discovery Inc. for its validation documentation and test the control in your own validation before you rely on it.
Collaborative Drug Discovery Inc.'s own Part 11 pageread 2026-10-22
How we read the vendors
Verdicts are editorial: no vendor can buy a verdict position or displace another vendor.
verified means we read the control described on the vendor's own documentation (help centre, validation pack page, compliance paper or trust page) on 2026-10-22. stated means the vendor claims it and we did not check it. not stated means the vendor publishes nothing on it.
FDA keeps no list of certified or approved Part 11 software. Compliance is a validation claim each regulated company makes for its own use of a system, so a vendor's Part 11 claim is where your validation starts, not where it ends.
A demo script for each role
A sales demo shows the happy path. Send this script ahead and ask the vendor to run it live, in a validated or trial tenant, with three of your own people at the keyboard. The twelve steps cover the first eight rows of the table.
Copy takes the role on screen. Print takes all three.
Once the notebook is live, the trail becomes a review job. The audit trail review checklist builds the list of events to review and how often.
Where a paper notebook still wins
A bound notebook signed in ink is outside Part 11 altogether. GLP still governs it, and § 58.130(e) reads like a paper-notebook SOP: data recorded “directly, promptly, and legibly in ink”, entries “dated on the date of entry and signed or initialed”, and changes that do “not obscure the original entry”, with the reason, date and signature.
Scroll sideways for the full table
| Question | Bound paper notebook | ELN |
|---|---|---|
| Does Part 11 reach it? | No. Part 11 applies to records in electronic form.§ 11.1(b) | Yes, when the entry is a record a predicate rule requires, or a copy kept beside paper that you rely on.§ 11.1(b), 2003 guidance |
| Signing an entry | In ink, dated on the date of entry, signed or initialed by the person entering the data (GLP).§ 58.130(e) | An e-signature that shows name, date and time, and meaning, executed with two distinct components.§ 11.50, § 11.200(a) |
| Changing an entry | Without obscuring the original entry, with the reason, dated and signed at the time of the change (GLP).§ 58.130(e) | A secure, computer-generated, time-stamped trail; changes do not obscure what was recorded before.§ 11.10(e) |
| Validating the system | Nothing to validate. | Validation for your intended use, including the ability to discern invalid or altered records.§ 11.10(a) |
| Letter to FDA | None. | A one-time certification that your e-signatures are the legally binding equivalent of handwritten ones.§ 11.100(c) |
| Instrument output | A printout pasted in. If the instrument's data is dynamic, its electronic file may still be the record to keep.PIC/S PI 041-1 | The original file attaches to the entry and travels with its export.§ 11.10(b) |
Paper wins for a small team with few regulated entries, little instrument data and no wish to validate a system or send FDA a signature letter. It loses on instrument data, search and copies.
Inspection risk
The hybrid trap. Keep paper as the record and an ELN as a convenience copy, and the moment anyone relies on the ELN copy for regulated work it becomes a Part 11 record, by FDA's 2003 guidance. Decide which one is the record and write it into an SOP, as the guidance recommends.
Takeaway
Pick paper or an ELN per record type, not per lab. Then check each kept record against the attributes in the ALCOA+ record check.
Questions
Is there an FDA-approved or Part 11 certified ELN?
No. FDA keeps no list of certified or approved Part 11 software. Part 11 binds the people who use a system, so compliance is a claim your lab makes for its own use, backed by its own validation under § 11.10(a). A vendor's statement is where that work starts.
Does Part 11 require a witness signature on notebook entries?
No. Part 11 sets what any electronic signature must show and how it is executed. Whether an entry needs a second person comes from your predicate rule and your SOPs. Once you witness electronically, though, the witness signature is a Part 11 signature: it needs the witness's printed name, the date and time, and its own meaning under § 11.50, and two components to execute under § 11.200(a). The signature manifestation check walks a printed entry through those three items.
Our ELN is for research only. Does Part 11 apply?
Only to records a predicate rule requires, records you submit to FDA, and electronic records you keep alongside paper and rely on for regulated work. Discovery notes nobody relies on for a GLP study, a batch or a submission sit outside it. Run one notebook through the Part 11 applicability checker and write the answer into an SOP, as FDA's 2003 guidance recommends.
Do we need MFA or digital signatures in a cloud ELN?
Part 11 does not require them. § 11.200(a)(1) accepts “an identification code and password”. Encryption and digital signature standards appear in § 11.30 as additional measures for open systems only. On the pages we read, Signals Notebook, Labguru ELN and SciNote Premium describe themselves as a closed system. Classify your own set-up with the open vs closed system check, and read Part 11 for cloud and SaaS systems for what the vendor and your lab each own.
We are an EU or export lab. Which notebooks speak to Annex 11?
Annex 11 § 14 expects e-signatures to be permanently linked to their record and to include the time and date they were applied. Of the six, Benchling Notebook, Signals Notebook and SciNote Premium publish an Annex 11 statement; the rest publish none. The 2011 Annex 11 is still the text in force. Our Annex 11 guide for US labs covers where it asks for more than Part 11.
Which of these fits a device maker?
None of the six names device makers in what it says it fits. If your Part 11 records are design, complaint and quality records rather than bench experiments, start with the medical device QMS software comparison.
Sources
- 21 CFR Part 11, Electronic Records; Electronic Signatures (eCFR), eCFR, National Archivesread 2026-10-22
- Part 11, Electronic Records; Electronic Signatures: Scope and Application (guidance, 2003), U.S. Food and Drug Administrationread 2026-10-22
- 21 CFR 58.130, Conduct of a nonclinical laboratory study (CFR annual edition, 2025-04-01), govinfo.gov, U.S. Government Publishing Officeread 2026-10-22
- 21 CFR Part 211, CGMP for Finished Pharmaceuticals (eCFR), eCFR, National Archivesread 2026-10-22
- EudraLex Volume 4, Annex 11: Computerised Systems (2011), European Commissionread 2026-10-22
- PI 041-1, Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments, PIC/Sread 2026-10-22
- Benchling Notebook: Part 11 and compliance page, Benchlingread 2026-10-22
- Signals Notebook: Part 11 and compliance page, Revvity Signalsread 2026-10-22
- Labguru ELN: Part 11 and compliance page, BioData Inc.read 2026-10-22
- SciNote Premium: Part 11 and compliance page, SciNoteread 2026-10-22
- SciSure ELN: Part 11 and compliance page, SciSureread 2026-10-22
- CDD Vault ELN: Part 11 and compliance page, Collaborative Drug Discovery Inc.read 2026-10-22