Cognidox is a configurable document management system with CAPA, change and training modules on top, priced for small teams. The reasons people look past it are mostly about design controls, software, post-market workflows and terms you can’t read before you buy. Here’s what our evidence shows, which alternatives fit which situation, and when Cognidox remains the better pick.
Why teams look for Cognidox alternatives
Quality processes you build yourself. CAPA, NCR and change requests run as configurable forms on top of the document system.12 Complaints and supplier management are listed as modules, and audits run as documents and forms, but none of the three has a help-center article describing the workflow.34 Cognidox’s own ISO 13485 mapping covers regulatory reporting only by storing procedures.4
Document-based design controls. Design control uses “Document Holders”, controlled bundles that act as phase gates. Cognidox says requirements, risks and tests are linkable, but no help article or manual page shows how, and we found no risk register or ISO 14971 tool.5
Software development. We found no IEC 62304 features and no documented Jira or Git integration beyond a command-line client and an API.53
Prices beyond the entry tier. Starter costs £6,000 a year for up to 5 users and has no e-signatures. Growth, which a 10-person team needs, isn’t priced; in March 2026 the plan with e-signatures cost £35 per user per month with a 20-user minimum.67 The validation pack, SSO, API and LMS are add-ons or higher tiers, without published prices.6 Per-user list prices rose 17–20% from March 2025 to March 2026.87
No public terms. We found no public terms of service, data processing agreement or subprocessor list.9
Old reviews. All 11 Capterra reviews date from 2015 to 2022, before the October 2025 sale to Recur Software and the 2026 repricing.1011
Which alternative fits your situation
You want linked design controls and risk: Greenlight Guru or Qualio
Greenlight Guru’s product tour shows a design control matrix that links user needs, inputs, outputs, verification and validation, next to a risk matrix of hazards, hazardous situations and harms.12 Trace graphs flag missing links across design, risk and tests.13 Complaint handling includes a step for deciding whether a regulatory report is needed.14 Validation documents come with every release at no extra cost.15 It costs more than Cognidox: eQMS packages start at $12,000 a year, implementation is extra, and Vendr reports a median of $43,989.1516
Qualio includes design controls in both standard plans: up to three requirement levels with verification and validation test cases, and ISO 14971 risk.1718 It publishes its terms, a data processing addendum and a subprocessor list that names AWS in Dublin as the web-application host.192021 Qualio doesn’t publish prices, and every plan carries an implementation fee.17 Complaints appear only as an example template in its Events module.22 See Greenlight Guru vs Qualio.
You build software as a medical device: Matrix Requirements
Matrix Requirements documents configurable traceability rules and reports that show broken or outdated links.2324 It links issues to Jira, GitHub, GitLab and Azure DevOps, and its template package covers IEC 62304.2526 Prices are published, and you can start a trial yourself without a credit card.2728 A full QMS takes a second product, the Salesforce-based Matrix Quality. For a 10-person team, three Matrix Req users plus ten Matrix Quality licences come to about $21,800 a year at published prices.2930
You want Word-based documents with complaints and validation included: SimplerQMS
In SimplerQMS, documents are written in Word, Excel or PowerPoint and checked back in.31 Complaints are a default event type, and event types can require a reportability assessment.3233 The Starter plan costs $17,500 a year for up to 15 users and includes implementation, IQ/OQ/PQ validation, data migration and training.34 Its terms are public and add a fixed 5% to all prices every 1 January; its data processing agreement is public too.3536 Design controls and risk are document collections, as in Cognidox.3738
You’re a small team that wants linked records at a low price: Formwork
Formwork publishes all its prices: Starter costs 99 € a month plus VAT for up to 5 users, and QMS + Techdoc costs 499 € a month plus VAT for unlimited users.39 The vendor says Part 11 e-signature features are in all plans.40 Each product records its IEC 62304 safety class, and requirements link to failure modes, risk controls and tests.4142 Its gaps matter: complaints are logged as incidents with no documented investigation step, we found no internal audit planning, and the vendor has no ISO 27001 certification, which Cognidox holds.43444546 It has 2 reviews on G2, too few for a rating.47
When to stay with Cognidox
Cognidox is a sound choice if these strengths matter more to you than the gaps above:
- Low entry price. £6,000 a year for up to 5 users; the March 2026 list worked out at about £8,400 a year for 20 users with e-signatures.67
- Document control and Part 11. Approvers re-enter a password or authenticator code, the role and meaning are recorded, and an approval manifest is added to the PDF. Cognidox publishes clause-by-clause mappings for Part 11, Part 820 and ISO 13485.484
- Certified vendor and hosting choice. Cognidox Ltd holds ISO/IEC 27001:2022 from BSI. Data can sit in London, Frankfurt, Newark or Tokyo, and on-premises installation is possible.464
- Flexible forms. If your SOPs don’t fit a fixed workflow, you can adapt CAPA, change and supplier forms to them.21
- Guided trial. The 14-day trial is set up with your own documents, admin training and a named technical contact.49
- Clean document export. Documents export in bulk in their original format and as PDFs, with metadata, versions and approvals.4
If you stay, ask for the Growth price, the validation pack price, a renewal cap and the contract terms in writing.
Cognidox knowledge base: Forms, an overview. Vendor documentation, checked 4 Oct 2026. ↩︎ ↩︎
Cognidox: CAPAs and non-conformance. Vendor website, checked 4 Oct 2026. ↩︎ ↩︎
Cognidox: Lean eQMS. Vendor website, checked 4 Oct 2026. ↩︎ ↩︎
Cognidox: Compliance solutions (Part 11, Part 820, ISO 13485 mappings). Vendor website, checked 4 Oct 2026. ↩︎ ↩︎ ↩︎ ↩︎ ↩︎
Cognidox: Design controls. Vendor website, checked 4 Oct 2026. ↩︎ ↩︎
Cognidox: Pricing. Vendor website, checked 4 Oct 2026. ↩︎ ↩︎ ↩︎
Cognidox pricing page, archived 9 Mar 2026. Vendor website (Wayback Machine), checked 4 Oct 2026. ↩︎ ↩︎ ↩︎
Cognidox pricing page, archived 27 Mar 2025. Vendor website (Wayback Machine), checked 4 Oct 2026. ↩︎
Cognidox: Privacy policy. Vendor legal page, last updated 13 Jul 2026. ↩︎
Capterra: Cognidox reviews. Review site, checked 30 Sep and 4 Oct 2026; review-source labels checked 3 Oct 2026. ↩︎
Cognidox: AI summary. Vendor website, updated 18 Jun 2026, checked 4 Oct 2026. ↩︎
Greenlight Guru: Interactive product tour. Vendor product tour with screenshots (captured 2024), checked 30 Sep 2026. ↩︎
Greenlight Guru: Product development software. Vendor website, checked 29 Sep 2026. ↩︎
Greenlight Guru: Complaint management software. Vendor website, checked 29 Sep 2026. ↩︎
Greenlight Guru: Quality pricing and packages. Vendor website, checked 29 Sep 2026. ↩︎ ↩︎
Vendr: Greenlight Guru pricing. Price benchmark, checked 29 Sep 2026. ↩︎
Qualio: Plans and pricing. Vendor website, checked 29 Sep 2026. ↩︎ ↩︎
Getting Started with Design Controls in Qualio. Vendor help center, checked 29 Sep 2026. ↩︎
Qualio: Terms of Service. Vendor legal page (effective 13 Aug 2024), checked 1 Oct 2026. ↩︎
Qualio: Data Processing Addendum. Vendor legal page, checked 29 Sep 2026. ↩︎
Terms and Policies (subprocessor list). Vendor help center, 24 Nov 2025. ↩︎
Forms and Qualio. Vendor help center, checked 29 Sep 2026. ↩︎
Matrix One user manual: Traceability. Help center, checked 29 Sep 2026. ↩︎
Matrix One user manual: Traceability management. Help center, checked 29 Sep 2026. ↩︎
Matrix One user manual: GitHub and GitLab integration. Help center, checked 29 Sep 2026. ↩︎
Matrix One blog: SxMD templates package. Vendor blog, published 2 Oct 2023. ↩︎
Matrix One: Matrix Req product page, pricing section. Vendor price list (shown with JavaScript; also in the page source), checked in a browser 30 Sep 2026 and in the page source 4 Oct 2026. ↩︎
Matrix One: Free trial. Vendor website, checked 29 Sep 2026. ↩︎
Matrix One: Company Plus plan page. Unlinked vendor price page, updated Feb 2026, checked 29 Sep 2026. ↩︎
Matrix One: Matrix Quality product page, ROI calculator and FAQ. Vendor website, checked 29 Sep 2026. ↩︎
SimplerQMS: Technology platform. Vendor website, checked 30 Sep 2026. ↩︎
SimplerQMS help: Events settings. Vendor documentation, checked 30 Sep 2026. ↩︎
SimplerQMS help: Vigilance reporting. Vendor documentation, checked 30 Sep 2026. ↩︎
SimplerQMS: Pricing and licenses. Vendor website, checked 30 Sep 2026. ↩︎
SimplerQMS A/S: Terms and conditions. Vendor legal page, last updated 14 Oct 2024, checked 30 Sep 2026. ↩︎
SimplerQMS A/S: Data processing agreement. Vendor legal page, last updated 13 Mar 2024. ↩︎
SimplerQMS: Design control software. Vendor website, checked 30 Sep 2026. ↩︎
SimplerQMS: Risk management. Vendor website, checked 30 Sep 2026. ↩︎
Formwork pricing, archived 3 Oct 2026. Vendor website (Wayback Machine), read 4 Oct 2026; also checked in a browser 1 Oct 2026. ↩︎
Formwork Manual: Electronic Signatures, archived 4 Oct 2026. Vendor documentation, published 9 Sep 2026. ↩︎
Documenting your medical device in Formwork, archived 25 Apr 2025. Vendor documentation, updated 1 Oct 2024. ↩︎
Software requirements and design inputs in Formwork, archived 25 Apr 2025. Vendor documentation, updated 1 Oct 2024. ↩︎
Formwork Manual: Incidents & Complaints, archived 4 Oct 2026. Vendor documentation, published 9 Sep 2026. ↩︎
Formwork Manual: Non Conformities, archived 4 Oct 2026. Vendor documentation, published 9 Sep 2026. ↩︎
Formwork Manual: Compliance & Passing Audits, archived 4 Oct 2026. Vendor documentation, published 22 Jan 2026. ↩︎
BSI certificate IS 716399, ISO/IEC 27001:2022, Cognidox Ltd. Certificate published by the vendor, valid to May 2029. ↩︎ ↩︎
G2: Formwork eQMS reviews. Review site, checked 30 Sep 2026. ↩︎
Cognidox knowledge base: What are extended approvals?. Vendor documentation, checked 4 Oct 2026. ↩︎
Cognidox: Free trial. Vendor website, checked 4 Oct 2026. ↩︎
Why people switch: Complaints, supplier, audit and design controls are thinly documented and largely document- or form-based. The validation pack and SSO are unpriced add-ons, and the LMS needs the Scale tier or an add-on. Read our Cognidox review.
- 1
OpenRegulatory Formwork
OpenRegulatory (OpenReg GmbH), $7k/yr
You're an early-stage device startup, especially one building software, and want a cheap, self-serve QMS with templates and linked requirements, risks and tests.Watch out: Complaints are logged as incidents with no documented investigation step, and we found no internal audit planning, UDI or DMR/DHR features. The vendor has no ISO 27001 certification and offers no audit rights.
7.8out of 10 - 2
Matrix Requirements (Matrix One)
Matrix One (Matrix Requirements GmbH), from $22k/yr
You build software or software-heavy devices and need design controls, risk and test traceability tied to your QMS.Watch out: A full QMS takes two products from Matrix One: Matrix Req, plus Matrix Quality, a Salesforce-based eQMS acquired in 2026 and priced separately.
7.5out of 10 - 3
Greenlight Guru
Greenlight Guru, from $12k/yr
You build a medical device, want design controls, ISO 14971 risk and quality events linked in one MedTech-only system, and can budget well above the entry price.Watch out: Users report the bill growing quickly as the team grows, and implementation is charged on top of the subscription.
7.4out of 10 - 4
SimplerQMS
SimplerQMS A/S, from $17.5k/yr
You run a small or mid-sized device or pharma company, write your SOPs in Microsoft Word, and want implementation, validation and training included in one yearly price.Watch out: Design controls, risk and software lifecycle are managed as documents with no native traceability, and contracts auto-renew with a 90-day notice period and a 5% yearly price rise.
7.1out of 10 - 5
Qualio
Qualio, Inc., est. $12–30k/yr
You're a growing device or combined device-and-pharma company that wants a QMS your whole team will actually use, with design controls linked to Jira and data hosted in the EU.Watch out: Prices aren't published, every plan carries an implementation fee, and complaint handling, vigilance reporting and production records aren't dedicated features.
6.8out of 10 - 6
Orcanos
Orcanos Ltd., pricing on request
You build a software-heavy or electromechanical device and want requirements, risk, tests and QMS records traced in one system rather than two tools joined by an integration.Watch out: Prices are not published, and supplier, audit, nonconformance and complaint workflows are described mainly on marketing pages rather than in the help center.
6.7out of 10 - 7
Arena QMS
Arena, a PTC business, est. $12–25k/yr
You build physical medical devices with outsourced manufacturing and want CAPA, complaints, training and design records linked to the same BOM and change orders as your engineering data.Watch out: Pricing is quote-only with paid implementation and validation add-ons. There is no risk register, IEC 62304 support or electronic regulatory reporting.
6.6out of 10 - 8
Ketryx
Ketryx Corporation, pricing on request
You build software as a medical device, your engineers live in Jira and Git, and you want design controls, risk and IEC 62304 records generated from that work.Watch out: We found no documented supplier, internal audit, DMR/DHR or vigilance-reporting workflows, so most device companies will run it next to another eQMS.
6.5out of 10 - 9
Ideagen Quality Management
Ideagen, est. $22–29k/yr
You make physical devices or combination products, want proven CAPA, audit, supplier and document workflows with Part 11 signatures, and handle design controls and risk files elsewhere.Watch out: Design controls, ISO 14971 risk files, vigilance reporting and IEC 62304 support aren't documented as product features, and the standard agreement defaults to 24 months with automatic renewal unless the order form says otherwise.
6.4out of 10 - 10
Scilife
Scilife NV, pricing on request
You run a GMP-regulated pharma, biotech or combined device and pharma operation and want an easy-to-learn eQMS with validation documents included.Watch out: Device-specific features are thin: risk isn't linked to design controls, complaints use a generic events workflow, and there's no Jira or Git integration.
6.3out of 10 - 11
Dot Compliance
Dot Compliance Ltd., pricing on request
You run a device, pharma or combination-product company and want a pre-configured GxP quality system on Salesforce that goes live in weeks to a few months.Watch out: Prices, contract terms and data export aren't published, and there's no documented support for software development (IEC 62304) or developer tools.
5.9out of 10 - 12
ETQ Reliance (Octave Reliance)
Octave Intelligence plc (formerly ETQ), pricing on request
You run a multi-site medical device or combined device and pharma manufacturer and want one configurable system for documents, CAPA, complaints with eMDR, suppliers and audits across sites.Watch out: There's no design-controls, ISO 14971 risk-file or IEC 62304 module, and prices, contract length and hosting regions aren't published.
5.1out of 10 - 13
MasterControl
MasterControl Solutions, Inc., est. $25–72k/yr
You run a larger, multi-site device or combined device-and-pharma quality organisation and need a configurable, validated system for documents, training, CAPA and audits.Watch out: Prices, hosting location and exit terms aren't published, and design controls, risk files and software development support are weak for device R&D teams.
5.1out of 10 - 14
Qualityze
Qualityze Inc., pricing on request
You make physical devices or combine devices and pharma, already use Salesforce or want to, and need configurable complaint, vigilance, CAPA and supplier workflows across several sites.Watch out: Design controls and FMEA are still unreleased roadmap items, there are no public prices, terms, DPA or hosting details, and many reviews were posted in year-end bursts.
5.1out of 10
Cognidox vs the top alternatives
| Cognidox | OpenRegulatory Formwork | Matrix Requirements (Matrix One) | Greenlight Guru | SimplerQMS | |
|---|---|---|---|---|---|
| Built-in document editor | NoDocuments are uploaded files edited in their own apps; forms are filled in the browser | YesRich-text editor with tables and images, stored as Markdown | YesRich-text editor for items and generated documents | NoDocuments are files; 2024 tour shows upload and download, editing via Office or Google | NoDocuments are written in Microsoft Office, not in a built-in editor |
| Edit in Word or Google Docs | YesOffice add-in for Word, Excel and PowerPoint; cross-platform version needs Office 365 | Partly or add-onGoogle Docs and Sheets edited in Google with sync; Word files can be uploaded but not edited in place | Partly or add-onMatrix Quality only (Office 365, SharePoint/Google); Matrix Req imports Word but can't edit in it | YesCo-edit in Google Docs and Microsoft Office for the web | YesWord, Excel and PowerPoint via Microsoft 365 and a Word add-in; Microsoft 365 licences required |
| SOP templates included | Partly or add-onCAPA, NCR, change and other form templates included; SOP templates only mentioned vaguely | YesOpenRegulatory's free QMS and technical documentation templates built in | YesSxMD SOP and document templates on Company plans | YesQMS templates listed in the eQMS package; 70+ SOPs and forms | YesISO 13485 and 21 CFR 820 template packages included |
| Jira or Git integration | Partly or add-onCommand-line client for source-control hooks and REST/SOAP API; no documented Jira or Git integration | NoVendor says there's no Jira or development-tool integration, by design; CI pipelines can file test results through the MCP API | YesJira, GitHub, GitLab and Azure DevOps | YesJira and GitHub integrations | Partly or add-onJira named on marketing pages; no documented integration |
| IEC 62304 software features | Not confirmed yetNo IEC 62304 features found | YesSafety class per product, requirement categories, detailed design for class C, tests and test runs | YesSoftware traceability and IEC 62304 templates | YesSoftware release management aligned to IEC 62304; SBOM scanning | Not confirmed yetOnly a generic 'supports alignment with IEC 62304' claim |
| Validation package included | Partly or add-onValidation pack with IQ/OQ/PQ templates and test evidence, sold as an add-on | YesPre-filled validation report with screenshots of each tested requirement, generated in the app | YesValidation project with plans, tests and reports | YesIQ protocol plus OQ/PQ reports with every release, included | YesValidation plan, report and IQ/OQ/PQ included; revalidated each release |
| Public API | Partly or add-onREST and SOAP API; reference docs only inside the product; Scale tier or add-on | Partly or add-onMCP (JSON-RPC) API with API tokens and a public tools reference; no REST API | YesDocumented REST API; Salesforce APIs for Matrix Quality | Partly or add-onREST API exists; documentation is for customers only | Partly or add-onAPI stated and API keys in admin settings; no public documentation |
| Single sign-on (SSO) | Partly or add-onSAML SSO (Entra ID, Google) on higher packages or as an add-on | Partly or add-onGoogle sign-in; no SAML SSO found | YesMatrix Req: Enterprise Plus only; Matrix Quality via Salesforce | YesSSO listed as a platform feature | YesMicrosoft Entra ID and Google Workspace on all licence types |
| Supplier portal | YesLimited Access Partner accounts give suppliers scoped access | Not confirmed yetSupplier list for your own evaluations; no supplier access found | YesMatrix Quality portal for supplier forms and SCARs | Partly or add-onSecure sharing with suppliers; no dedicated portal documented | Not confirmed yetNo supplier portal found |
| Training with quizzes | YesLMS quizzes with question pools and pass marks (Scale tier or LMS add-on) | YesTraining effectiveness by quiz or a named person (paid plans) | YesMultiple-choice training questions in Matrix Req | YesAI drafts training quizzes | YesMultiple-choice quizzes with a quiz report |
| FDA MDR or EU vigilance reporting | Not confirmed yetNo FDA MDR or EU vigilance reporting feature found | Partly or add-onIncidents record whether they are serious and reportable; no MDR or EU vigilance report forms | Partly or add-onReportability assessment on a marketing page only | Partly or add-onReportability decision and report task; no eMDR submission | Partly or add-onVigilance reportability assessment; reports filed outside the system |
| AI features | Not confirmed yetNo AI features documented; the new owner plans to add AI | YesAI drafting of QMS and technical documents; data goes to OpenAI only when you click generate | YesMatrix Mind, AI design tools, compliance checker | YesGreenlight Guru AI: search, answers, summaries; ISO 42001 | YesAI-generated change summaries when sending documents for approval |