Best 21 CFR Part 11 compliant QMS software

No software is Part 11 compliant on its own. Here is what each QMS gives you towards it: signatures, audit trails and validation evidence.

By · Updated

What 21 CFR Part 11 requires

Part 11 applies to records kept electronically under FDA record requirements. It sets the criteria under which electronic records and electronic signatures count as equivalent to paper records and handwritten signatures.1 For a device maker, the records in question are mostly the quality records the FDA’s Quality Management System Regulation (QMSR) requires. Since 2 February 2026 the QMSR incorporates ISO 13485:2016 by reference.2

FDA’s guidance on the scope of Part 11 narrows how the agency enforces some of its controls, including validation and audit trails, and recommends that companies base their approach on a justified and documented risk assessment. It doesn’t remove the record requirements of the underlying rules.1 ISO 13485 has its own requirement: clause 4.1.6 asks you to validate software used in the quality system, in proportion to the risk of its use.3

What software can and can’t do

The phrase “Part 11 compliant software” is misleading. A QMS can provide technical controls: unique logins, signatures linked to the record they sign, the signer’s name, time and the meaning of the signature, and an audit trail of changes. Compliance also needs things only you can do: validating the system for your intended use, controlling who gets access, training people, and written procedures that hold people accountable for their signatures. Ideagen’s own Part 11 supplement says the procedural controls remain the customer’s job.4 Treat any vendor’s Part 11 claim as a list of features plus validation evidence, and check both.

What to look for in Part 11 software

  • Signing that asks who you are. Re-entering a password or a second factor at each signature, and a clear rule for how signing works with single sign-on.
  • The meaning travels with the signature. Signer, date and time, and meaning (reviewed, approved) recorded with the record and printed on the PDF or export.
  • An audit trail you can use. Who changed what and when, locked against editing, searchable and exportable for an inspection.
  • A validation package and what it costs. Ask what’s in it (requirements, test scripts, trace matrix, IQ/OQ/PQ or a Computer Software Assurance approach), whether it’s updated with each release, and whether it’s included.
  • Signatures on every plan. Check that the plan you’re quoted includes Part 11 signatures and the validation documents.
  • Readable exports. Records with their signatures and audit trail, in open formats, both for an inspection and when you leave.

Common gaps we found

Part 11 features on higher plans only. Cognidox includes Part 11 signatures only in its Growth tier and above.5 Formwork’s validation report is only on its 499 € tier.6

Validation packs priced separately or hidden. Ideagen sells an IQ/OQ pack for £4,000 and an IQ/OQ/PQ pack for £9,320.7 Cognidox sells its validation pack as an add-on.5 Ketryx shares its package only after an NDA, and the contents of Orcanos’s and Dot Compliance’s packs aren’t published.8910 Greenlight Guru, by contrast, ships an IQ protocol and completed OQ and PQ reports with each release, included in the subscription.11

Single sign-on and signatures. MasterControl users report that e-signatures need a separate password even when they log in with single sign-on.12 Orcanos can require single sign-on re-authentication for signing.9

Little public documentation. ETQ Reliance and MasterControl don’t publish manuals, so their Part 11 controls can only be checked from product pages, demos and user reports.1312

Weaker supplier evidence. Your validation relies partly on the vendor’s own quality and security. Formwork has no ISO 27001 certificate and offers no audit rights to customers,6 we found no ISO 27001 or SOC 2 claim for Scilife or Qualityze,1415 and the ETQ platform’s archived ISO 27001 certificate expired in May 2026 with no renewal found.16

How we ranked Part 11 software

The list below uses two rows of our clause matrix: electronic signatures and control of records. A system gets a full point for a row when its documentation, a demo or an independent source shows the workflow, and half a point when the feature is limited, sold as an add-on or only named on a marketing page.17 Every system we had reviewed by October 2026 documents both, so the order follows the overall score, which also counts validation packages and security certifications under compliance coverage. The note under each system says what it provides towards Part 11. Our ranking method explains every criterion.

  1. FDA: Part 11, Electronic Records; Electronic Signatures: Scope and Application. FDA guidance, Sep 2003, checked 1 Oct 2026. ↩︎ ↩︎

  2. FDA: Quality Management System Regulation (QMSR). FDA, updated 2 Feb 2026, checked 1 Oct 2026. ↩︎

  3. ISO 13485:2016 Medical devices: Quality management systems: Requirements for regulatory purposes, clause 4.1.6. ISO, checked 1 Oct 2026. ↩︎

  4. Ideagen Quality Management review, features section, checked 4 Oct 2026. ↩︎

  5. Cognidox review, features and validation sections, checked 4 Oct 2026. ↩︎ ↩︎

  6. OpenRegulatory Formwork review, pricing and security sections, checked 4 Oct 2026. ↩︎ ↩︎

  7. Ideagen Quality Management Professional pricing document, G-Cloud 14. Vendor price list, dated 14 Oct 2025, checked 1 Oct 2026. ↩︎

  8. Ketryx review, security and validation section, checked 4 Oct 2026. ↩︎

  9. Orcanos review, security and validation section, checked 4 Oct 2026. ↩︎ ↩︎

  10. Dot Compliance review, security and validation section, checked 4 Oct 2026. ↩︎

  11. Greenlight Guru review, security and validation section, checked 4 Oct 2026. ↩︎

  12. MasterControl review, security and validation section, checked 4 Oct 2026. ↩︎ ↩︎

  13. ETQ Reliance review, features section, checked 4 Oct 2026. ↩︎

  14. Scilife review, security and validation section, checked 4 Oct 2026. ↩︎

  15. Qualityze review, security and validation section, checked 4 Oct 2026. ↩︎

  16. ETQ Reliance review, security and validation section, checked 4 Oct 2026. ↩︎

  17. How we rank QMS software: compliance coverage. ↩︎

The Part 11 QMS software we reviewed, ranked

Ranked by how fully each system covers Electronic signatures and Control of records in its documentation, then by overall score. Every system we reviewed documents all of these, so the order here is the overall score; the notes show where they differ. How we check features

  1. 1

    OpenRegulatory Formwork 7.8/10

    Electronic signatures: documentedControl of records: documented

    Users re-enter their credentials before each review or release, and signer, role, decision, time and meaning are printed on exports on every plan, but the validation report is only on the 499 € tier, and the vendor offers no audit rights and has no ISO 27001 certificate.

    $7k/yr · Review · Pricing

  2. 2

    Matrix Requirements (Matrix One) 7.5/10

    Electronic signatures: documentedControl of records: documented

    Matrix Req signs controlled documents with Part 11 signatures, locks them as PDFs and ships a validation project with pre-written requirements, tests, plan and report, while Matrix Quality, the separate Salesforce product, has its own electronic validation tooling.

    from $22k/yr · Review · Pricing

  3. 3

    Greenlight Guru 7.4/10

    Electronic signatures: documentedControl of records: documented

    Approvals use Part 11 signatures with audit trails as standard, and each release ships an installation qualification protocol and completed OQ and PQ reports, included in the subscription.

    from $12k/yr · Review · Pricing

  4. 4

    Cognidox 7.2/10

    Electronic signatures: documentedControl of records: documented

    Part 11 signatures ask for a password or authenticator code, record role and meaning and add an approval manifest page to the PDF, but they’re only in the Growth tier and above, and the validation pack is a paid add-on.

    from $8k/yr · Review · Pricing

  5. 5

    SimplerQMS 7.1/10

    Electronic signatures: documentedControl of records: documented

    Approvals use username-and-password e-signatures with a full audit trail, and validation documentation (plan, report and IQ/OQ/PQ) is included, with each release revalidated.

    from $17.5k/yr · Review · Pricing

  6. 6

    Qualio 6.8/10

    Electronic signatures: documentedControl of records: documented

    The e-signature is your email and password, the audit trail is searchable and exports to CSV, and the validation pack follows FDA’s Computer Software Assurance approach with a Part 11 assessment, though Qualio doesn’t say whether it costs extra.

    est. $12–30k/yr · Review · Pricing

  7. 7

    Orcanos 6.7/10

    Electronic signatures: documentedControl of records: documented

    A signature can be required on any status change of a record, and single sign-on can be required for signing, but the contents of the Release 6.0 validation pack aren’t published.

    Pricing on request · Review · Pricing

  8. 8

    Arena QMS 6.6/10

    Electronic signatures: documentedControl of records: documented

    Part 11 approvals cover change orders, quality processes and training, and Arena Validate provides a URS, trace matrix, executed IQ and OQ protocols, PQ templates and a validation report with each release.

    est. $12–25k/yr · Review · Pricing

  9. 9

    Ketryx 6.5/10

    Electronic signatures: documentedControl of records: documented

    Signatures use approval groups with multi-factor authentication, and a validation package ships with every major and minor release, shared through the Trust Center only after you sign an NDA.

    Pricing on request · Review · Pricing

  10. 10

    Ideagen Quality Management 6.4/10

    Electronic signatures: documentedControl of records: documented

    Administrators switch signatures on per task with their own declaration text, and a clause-by-clause Part 11 supplement covers audit trail and access controls, but IQ/OQ/PQ packs for your environment are priced separately.

    est. $22–29k/yr · Review · Pricing

  11. 11

    Scilife 6.3/10

    Electronic signatures: documentedControl of records: documented

    Part 11 signatures run across modules, and customers receive an executed GAMP 5 package with IQ, OQ, PQ and a trace matrix, updated 60 days before each medium or major release in a separate validation environment.

    Pricing on request · Review · Pricing

  12. 12

    Dot Compliance 5.9/10

    Electronic signatures: documentedControl of records: documented

    Signatures record their meaning with a time-stamped audit trail and multi-factor login, and every solution comes with a validation package, but its contents aren’t public.

    Pricing on request · Review · Pricing

  13. 13

    ETQ Reliance (Octave Reliance) 5.1/10

    Electronic signatures: documentedControl of records: documented

    A Part 11 and Annex 11 app binds an authenticated signature to each step with an audit trail, and a validation execution package is offered, but there’s no public manual to check the details.

    Pricing on request · Review · Pricing

  14. 14

    MasterControl 5.1/10

    Electronic signatures: documentedControl of records: documented

    E-signatures are standard in document management, and the Validation Excellence Tool and Validation on Demand are included at no extra cost, but users report that e-signatures still need a separate password when you log in with single sign-on.

    est. $25–72k/yr · Review · Pricing

  15. 15

    Qualityze 4.9/10

    Electronic signatures: documentedControl of records: documented

    Datasheets document e-signatures with signer name, date and time, and a validation package with plan, requirements, test scripts, trace matrix and summary report comes with every update.

    Pricing on request · Review · Pricing

Frequently asked questions

Is there 21 CFR Part 11 compliant software?
Not in the sense the label suggests. Part 11 applies to how you keep and sign FDA-required records. Software can provide the technical controls (signatures, audit trails, access control) and evidence that it works, but you still validate it for your use and write and follow the procedures around it. Ideagen’s own Part 11 supplement says the procedural controls remain the customer’s job.
Does Part 11 apply to our company?
It applies to records you keep electronically under FDA record requirements, such as quality records under the QMSR, and to electronic signatures on them. Part 11 is a US regulation, so it doesn’t apply to a company that only sells in the EU, though ISO 13485 still requires controlled records and validated software.
Do we need to validate our QMS software?
Yes. ISO 13485 clause 4.1.6 asks you to validate software used in the quality system for its intended use, and FDA’s Part 11 guidance recommends basing your approach on a justified and documented risk assessment. A vendor’s validation package covers the vendor’s testing; you still document that it fits your use.
Which vendors charge extra for Part 11 features or validation?
Cognidox offers Part 11 signatures only from its Growth tier and sells the validation pack as an add-on. Ideagen prices IQ/OQ and IQ/OQ/PQ packs separately. Formwork includes the validation report only on its 499 € tier. Greenlight Guru, SimplerQMS and MasterControl include validation documents or tools in the subscription.
Do single sign-on and Part 11 signatures work together?
It depends on the system. Orcanos can require single sign-on re-authentication for signing, and Ketryx uses multi-factor authentication for signatures. MasterControl users report that e-signatures still need a separate password. Test signing in the demo with your own identity provider.