LIMS for biotech and Part 11 labs: six vendors read against the rule
Published , reviewed
Verdict
- Best overall
- LabKey LIMSThe only LIMS here whose own documentation describes the signature, its link to the record, the two-part sign-in and the audit trail: 8 of 10 rows verified. Part 11 signatures come in the LIMS Enterprise and Biologics LIMS editions.
- Best for a small lab
- alt-LIMSA cloud LIMS configured with no-code tools, with IQ/OQ/PQ documentation sold as a subscription service (Validation Care), the part of Part 11 a lab with no validation staff finds hardest to cover. Its signature and audit-trail rows are claims we did not check.
- Best for a GMP biotech lab
- LabVantage PharmaPre-configured for pharma and biotech with batch management, stability testing and environmental monitoring, described as pre-validated under GAMP 5, with its audit trail and validation services documented. Test its signing rows yourself.
Fig. 01A LIMS is where a lab's results become regulated records: the value, who entered it, who changed it and why, who reviewed it and who released it. When a predicate rule requires those records and you keep them in the LIMS, Part 11 applies to the system. We read what six LIMS vendors publish about each Part 11 control on their own pages, and set it against what the rule asks of a result as it moves through a lab.
This page covers research, biotech, GLP, drug and biologics CGMP and device test labs. Clinical diagnostic lab rules are outside it. New to the category? Start with what a LIMS is and when it is Part 11 ready.
Where Part 11 lands in a LIMS
Vendors list Part 11 features; inspectors follow a result. These seven steps carry nearly every control in the rule, and each one sits on a record some other rule already requires.
Scroll sideways for all columns
| Step in the LIMS | The record | What Part 11 asks | The rule behind the record |
|---|---|---|---|
| 01Sample login | Sample ID, who received it, when, storage location | Access limited to authorised people § 11.10(d); the creation lands in the audit trail § 11.10(e) | GLP: the person entering data is identified at input § 58.130(e) |
| 02Result entry or instrument import | Raw value, units, instrument, analyst | Device checks on the source of input § 11.10(h); time-stamped trail of who entered what § 11.10(e) | Drug CGMP: lab records hold complete data from all tests § 211.194 |
| 03Change, recalculation or reprocessing | New value, reason, who and when | “Record changes shall not obscure previously recorded information” § 11.10(e) | GLP: changes made “so as not to obscure the original entry” § 58.130(e); FDA names reprocessing details in its HPLC audit-trail example |
| 04Second-person review | Reviewer's e-signature, meaning “review” | Printed name, date and time, meaning § 11.50; two signing components § 11.200(a); authority check § 11.10(g) | Your review SOP under the predicate rule that requires the record |
| 05Approval and release | Approver's e-signature, meaning “approval” | Signature linked so it cannot be excised, copied or moved § 11.70 | EU batch release: the Qualified Person certifies by electronic signature Annex 11 § 15 |
| 06Report or certificate of analysis | Printout or PDF of the signed result | Name, date and time, meaning on every printout § 11.50(b); accurate, complete copies § 11.10(b) | EU: clear printed copies; batch-release printouts show if data changed since entry Annex 11 § 8 |
| 07Archive | The result, its trail and its signatures | Ready retrieval for the whole retention period § 11.10(c); trail kept as long as the record § 11.10(e) | Retention comes from the predicate rule: § 211.180, § 58.195, § 600.12 |
Common misreading
“FDA no longer enforces Part 11 audit trails” is half true. Since 2003 FDA has said it does not intend to enforce the Part 11 versions of validation, audit trail, copies and retention, but it enforces every predicate rule, and rules such as § 58.130(e) (changes must not obscure the original entry) and § 211.68(b) (changes only by authorized personnel) cover much of the same ground for lab data. The signature sections § 11.50, § 11.70 and § 11.200 are enforced in full.
Takeaway
Before any demo, list your result's steps and the rule behind each one. The vendor rows that matter are the ones your steps touch. Our guide to GxP audit trails covers what the trail on a changed result has to show.
Requirement by requirement
10 rows, each read on the vendor's own pages. A row is verified only where the vendor's documentation describes the control; a “Part 11 compliant” line on a product page counts as stated.
Scroll sideways for all vendors
| Requirement | LabKey LIMS | LabWare LIMS | LabVantage Pharma | alt-LIMS | QBench | SampleManager LIMS Software |
|---|---|---|---|---|---|---|
| Signature shows name, date and time, and meaning§ 11.50 | verified | stated | stated | stated | stated | stated |
| Signature linked to its record so it cannot be moved§ 11.70 | verified | stated | stated | stated | stated | stated |
| Two distinct components to sign§ 11.200(a) | verified | stated | stated | stated | stated | stated |
| Secure, computer-generated, time-stamped audit trail§ 11.10(e) | verified | verified | verified | stated | stated | stated |
| Audit trail kept as long as the record§ 11.10(e) | verified | stated | stated | stated | stated | stated |
| Validation documentation to support the customer's own validation§ 11.10(a) | verified | verified | verified | verified | not stated | not stated |
| Accurate, complete copies for inspection§ 11.10(b) | verified | stated | stated | stated | stated | stated |
| Access and authority checks by role§ 11.10(d), (g) | verified | stated | stated | stated | stated | stated |
| Open-system controls: encryption, digital signatures§ 11.30 | stated | not stated | stated | stated | stated | not stated |
| EU Annex 11 statementEU GMP Annex 11 | stated | stated | 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.
How much each vendor documents
The table, counted. A high count of stated rows does not mean a weak product: it means the evidence is not on the public web, so your validation has to produce it.
- LabKey LIMS
- 8 verified, 2 stated, 0 not stated
- LabWare LIMS
- 2 verified, 7 stated, 1 not stated
- LabVantage Pharma
- 2 verified, 8 stated, 0 not stated
- alt-LIMS
- 1 verified, 9 stated, 0 not stated
- QBench
- 0 verified, 8 stated, 2 not stated
- SampleManager LIMS Software
- 0 verified, 7 stated, 3 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.
LabKey stands out because its help pages show the controls, not just the claim. The other five document at most two rows each, so their signature rows rest on claims or on a demo. That fits what the rule expects: validation is yours under § 11.10(a), whatever the vendor supplies. To scope it by risk rather than test everything, see computer system validation for small labs.
Which rows to read first, by lab
The predicate rule behind your records decides which rows carry the weight.
- Biotech R&D, discoveryOften no predicate rule yet
Read first: Audit trail, copies.
Part 11 reaches only records a predicate rule requires or that go to FDA. Research data that may later back a submission is safer kept with a trail and exportable from day one than re-created at the GLP or IND stage.
- Nonclinical study lab (GLP)21 CFR 58, § 58.130(e)
Read first: Audit trail, authority checks.
For automated data the person responsible for input “shall be identified at the time of data input”, and changes must not obscure the original entry.
- Drug or biotech QC under CGMP21 CFR 211, § 211.68(b), § 211.194
Read first: Audit trail, authority checks, copies.
Changes are “instituted only by authorized personnel”, a backup of data is kept, and lab records hold “complete data derived from all tests”.
- Biologics manufacturing21 CFR 600, § 600.12
Read first: Audit trail kept as long as the record.
Records are made concurrently with each step, legible and indelible, and kept at least five years after manufacture records close or six months after the latest expiry, whichever is later.
- Device maker's test lab21 CFR 820 (QMSR), § 820.35
Read first: Signature rows, validation documents.
The QMSR took effect on February 2, 2026 and supplements other parts of the chapter, so Part 11 still applies to the lab records it requires. See what the QMSR changes for a small device maker.
Vendor by vendor
Each card shows the six rows that matter most in a LIMS: the trail on results first, then signatures and the validation pack. Notes are the vendor's own caveats.
LabKey LIMS
LIMS- What it is
- LabKey LIMS is a single platform for samples, data, workflows and reporting, configured to match how a lab works. It tracks each sample from registration through storage, aliquoting and use in experiments, with an audit log of every change.
- Who it fits
- Research and biotech labs that want a configurable LIMS, with Part 11 signatures in the Enterprise and Biologics editions.
| Requirement | Status |
|---|---|
| Secure, computer-generated, time-stamped audit trail§ 11.10(e) | verified |
| Audit trail kept as long as the record§ 11.10(e) | verifiedBy default all audit log data is kept indefinitely; an administrator can set a shorter retention time. |
| Signature shows name, date and time, and meaning§ 11.50 | verifiedPart 11 electronic signatures are part of the LIMS Enterprise and Biologics LIMS editions. |
| Two distinct components to sign§ 11.200(a) | verified |
| Validation documentation to support the customer's own validation§ 11.10(a) | verifiedThe validation package is an add-on for LIMS Starter and LIMS Enterprise. |
| 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.
LabKey's own Part 11 pageread 2026-10-22
LabWare LIMS
LIMS- What it is
- LabWare LIMS is a configurable laboratory information management system offered as an enterprise deployment or as SaaS. LabWare also sells pre-configured SaaS editions, including QAQC for analytical quality control labs.
- Who it fits
- Pharma, biopharma and other regulated QC labs, from multi-site enterprise rollouts to a single QC lab on the SaaS edition.
| Requirement | Status |
|---|---|
| Secure, computer-generated, time-stamped audit trail§ 11.10(e) | verified |
| Audit trail kept as long as the record§ 11.10(e) | stated |
| Signature shows name, date and time, and meaning§ 11.50 | stated |
| Two distinct components to sign§ 11.200(a) | stated |
| Validation documentation to support the customer's own validation§ 11.10(a) | 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 LabWare's own pages. Ask LabWare for its validation documentation and test the control in your own validation before you rely on it.
LabWare's own Part 11 pageread 2026-10-22
LabVantage Pharma
LIMS- What it is
- LabVantage Pharma is a LIMS pre-configured with pharma and biotech templates and workflows, including batch management, stability testing and environmental monitoring. LabVantage describes it as pre-validated under GAMP 5 guidelines and deploys it as validated SaaS or on premises.
- Who it fits
- Pharma and biotech R&D, analytical and QC manufacturing labs.
| Requirement | Status |
|---|---|
| Secure, computer-generated, time-stamped audit trail§ 11.10(e) | verified |
| Audit trail kept as long as the record§ 11.10(e) | stated |
| Signature shows name, date and time, and meaning§ 11.50 | statedThe page describes Action and Reason fields that give each signature its meaning; it does not show how name and date appear. |
| Two distinct components to sign§ 11.200(a) | stated |
| Validation documentation to support the customer's own validation§ 11.10(a) | 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 LabVantage Solutions' own pages. Ask LabVantage Solutions for its validation documentation and test the control in your own validation before you rely on it.
LabVantage Solutions' own Part 11 pageread 2026-10-22
alt-LIMS
LIMS- What it is
- alt-LIMS is Scispot's LIMS for sample tracking, workflow automation and reporting, configured with no-code tools and an API. It runs in the cloud as part of Scispot's lab operating system alongside its ELN and QMS modules.
- Who it fits
- Biotech, drug discovery and contract testing labs that want a cloud LIMS with validation sold as a service.
| Requirement | Status |
|---|---|
| Secure, computer-generated, time-stamped audit trail§ 11.10(e) | stated |
| Audit trail kept as long as the record§ 11.10(e) | stated |
| Signature shows name, date and time, and meaning§ 11.50 | stated |
| Two distinct components to sign§ 11.200(a) | stated |
| Validation documentation to support the customer's own validation§ 11.10(a) | verifiedIQ/OQ/PQ documentation comes through Scispot Validation Care, a separate subscription service. |
| 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 Scispot's own pages. Ask Scispot for its validation documentation and test the control in your own validation before you rely on it.
Scispot's own Part 11 pageread 2026-10-22
QBench
LIMS- What it is
- QBench is a cloud-based, configurable LIMS for tracking orders, samples and tests, automating workflows and generating reports. It includes a built-in quality management system, customer portal and inventory management.
- Who it fits
- Small and mid-size testing labs that want a no-code cloud LIMS.
| Requirement | Status |
|---|---|
| Secure, computer-generated, time-stamped audit trail§ 11.10(e) | stated |
| Audit trail kept as long as the record§ 11.10(e) | stated |
| Signature shows name, date and time, and meaning§ 11.50 | stated |
| Two distinct components to sign§ 11.200(a) | stated |
| Validation documentation to support the customer's own validation§ 11.10(a) | not stated |
| 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 QBench's own pages. Ask QBench for its validation documentation and test the control in your own validation before you rely on it.
QBench's own Part 11 pageread 2026-10-22
SampleManager LIMS Software
LIMS- What it is
- SampleManager LIMS Software is an informatics solution for lab, data, process and compliance management across process development and manufacturing QA and QC. It includes built-in SDMS, ELN and LES functionality and deploys in the cloud or on premises.
- Who it fits
- Manufacturing QA/QC and process development labs, including plants that link the LIMS to MES and ERP systems.
| Requirement | Status |
|---|---|
| Secure, computer-generated, time-stamped audit trail§ 11.10(e) | stated |
| Audit trail kept as long as the record§ 11.10(e) | stated |
| Signature shows name, date and time, and meaning§ 11.50 | stated |
| Two distinct components to sign§ 11.200(a) | stated |
| Validation documentation to support the customer's own validation§ 11.10(a) | not stated |
| 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 Thermo Fisher Scientific's own pages. Ask Thermo Fisher Scientific for its validation documentation and test the control in your own validation before you rely on it.
Thermo Fisher Scientific'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.
What to ask each vendor
Pick a LIMS and copy the questions its public pages leave open. Rows with nothing published come first. Send them before the demo and ask for answers in writing: they become evidence in your validation file and feed the audit trail review checklist once you go live.
Pre-filled with the first vendor in the table. Each row is grouped by what the vendor publishes, read 2026-10-22.
Ask for the evidence2 of 10 rows
Claimed, not documented. Ask for the help page or the test script.
- stated§ 11.30
Open-system controls: encryption, digital signatures
Who controls access to the hosted system? If it is open, which encryption and digital signature standards protect records in transit?
From the vendor's pages: General encryption claim; no Part 11 open-system statement.
- statedEU GMP Annex 11
EU Annex 11 statement
If we supply the EU, which EU GMP Annex 11 clauses does your documentation map to, and where do you leave them to us?
Test in your own validation8 of 10 rows
Documented by the vendor. Confirm it in your configuration.
- verified§ 11.50
Signature shows name, date and time, and meaning
Show us a signed result on screen and on a printed report. Does it carry the signer's printed name, the date and time, and the meaning (review, approval)?
From the vendor's pages: Part 11 electronic signatures are part of the LIMS Enterprise and Biologics LIMS editions.
- verified§ 11.70
Signature linked to its record so it cannot be moved
How is each signature bound to the result it signs, so it cannot be cut, copied or moved onto another record?
- verified§ 11.200(a)
Two distinct components to sign
What does a signer enter at the first signing in a session, and at each signing after it? Name the two components.
- verified§ 11.10(e)
Secure, computer-generated, time-stamped audit trail
When a result is changed or recalculated, does the trail record who, when, the old and new value and the reason, without hiding the first entry?
- verified§ 11.10(e)
Audit trail kept as long as the record
How long is the audit trail kept, who can shorten or purge it, and does it survive an archive, an upgrade or a migration?
From the vendor's pages: By default all audit log data is kept indefinitely; an administrator can set a shorter retention time.
- verified§ 11.10(a)
Validation documentation to support the customer's own validation
Which validation documents do you supply (plan, IQ/OQ scripts, release notes, trace matrix), and do they come with every release?
From the vendor's pages: The validation package is an add-on for LIMS Starter and LIMS Enterprise.
- verified§ 11.10(b)
Accurate, complete copies for inspection
Can we export a complete record, with its audit trail and signatures, in readable and electronic form for an inspector?
- verified§ 11.10(d), (g)
Access and authority checks by role
Which roles can enter, review, approve, alter or delete a result, and who is allowed to change those roles?
To check a signed report from the demo against the rule, use the signature manifestation check.
Questions
Is there an FDA-approved or certified LIMS?
No. FDA keeps no list of certified or approved Part 11 software. Part 11 binds the people who use a system, so “Part 11 compliant” on a LIMS means the vendor states its product supports the controls. Your lab still validates it for its own use § 11.10(a) and writes the policies around it.
Does the vendor's validation package mean our LIMS is validated?
No. A package of plans and IQ/OQ scripts saves you writing tests for the vendor's standard functions, but validation covers your configuration, your workflows and your intended use. Treat the package as the start of your computer system validation, and trace each test back to a requirement in your own user requirement specification.
We print and sign our results on paper. Does the LIMS still need Part 11 controls?
FDA's 2003 guidance says that when paper printouts meet the predicate rule and are what you rely on, using a computer to produce them does not trigger Part 11. Once reviewers work from the screen, or the LIMS holds the only complete data, it does. FDA recommends you document that decision, for example in an SOP.
Does Part 11 require digital signatures, PKI or multi-factor sign-in?
No. § 11.200(a)(1) accepts “an identification code and password” as the two components. Encryption and digital signature standards appear only as additional measures for open systems under § 11.30. Whether a hosted LIMS is open or closed depends on who controls access; the open vs closed system check walks through it.
How long do we keep a LIMS audit trail?
Part 11 sets no period of its own. The trail is kept “for a period at least as long as that required for the subject electronic records” § 11.10(e), and the record's period comes from the predicate rule: for drug CGMP records at least one year after the batch expires § 211.180; for biologics the later of five years after manufacture records close or six months after the latest expiry § 600.12.
Should a biotech lab start with a LIMS or an ELN?
A LIMS runs samples, tests and results through a fixed workflow; an ELN records how an experiment was done. Many biotech labs need both, and the Part 11 rows that bite differ: result review and approval in a LIMS, witness signatures and entry locking in a notebook. Our guide to what a LIMS is covers the split, and the Part 11 ELN comparison reads the notebooks against the same rows.
Sources
Regulation text from the eCFR and EudraLex; guidance from FDA. Vendor sources are linked on each vendor card. General information, not regulatory advice.
- 21 CFR Part 11, Electronic Records; Electronic Signatures, eCFRread 2026-10-22
- Part 11, Electronic Records; Electronic Signatures: Scope and Application (guidance, 2003), FDAread 2026-10-22
- Data Integrity and Compliance With Drug CGMP: Questions and Answers (2018), 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
- 21 CFR Part 600, Biological Products: General, eCFRread 2026-10-22
- 21 CFR Part 820, Quality Management System Regulation, eCFRread 2026-10-22
- EudraLex Volume 4, Annex 11: Computerised Systems (2011), European Commissionread 2026-10-22