European Quality Management Software

#1 Qualio

Dublin, Ireland Three plans (Foundation, Growth, Scale) without a price list; every plan carries an implementation fee Demo on request

Best for: Venture-backed medtech and biotech companies replacing spreadsheets with a first audited quality system

• Operating company. Everworks Limited (trading as Qualio)
• Jurisdiction. EU (Ireland)
• Where the data sits. The pages checked do not name a data location
• Source code. Closed source
• Replaces. MasterControl, Veeva Vault QMS

Qualio is sold by Everworks Limited, trading as Qualio, from a registered office on City Quay in Dublin.

It is a hosted system for document control, training, supplier quality, quality events with CAPA, and design controls, aimed at companies that must show an FDA, ISO or notified-body auditor how a product was designed and released. Plans are Foundation, Growth and Scale: Foundation includes 5 editing users and 3 compliance frameworks, Growth 10 editing users and 5 frameworks, and read-and-sign users are unlimited.

The product maps a company's existing documents against FDA, MDR, ISO and GxP control sets and produces a gap analysis, and a Copilot drafts and reviews text inside the workflows. Continuous regulatory monitoring and automated evidence collection appear on Growth only. The integration catalogue covers Jira, GitHub, GitLab, Azure DevOps and TestRail. Where the data lives is not stated on the pages checked, the price is on request, and an implementation fee applies to each plan.

Standout feature. Qualio pairs framework gap analysis with a drafting Copilot and a catalogue of developer-tool integrations on the same quality record.

#2 SimplerQMS

Copenhagen, Denmark Starter tier from USD 17,500 a year for up to 15 users; Team and Enterprise tiers are quoted Demo on request

Best for: Life-science teams that want validation and onboarding folded into a single annual fee

• Operating company. SimplerQMS A/S
• Jurisdiction. EU (Denmark)
• Where the data sits. Hosted on Amazon Web Services and Microsoft Azure, according to the vendor
• Source code. Closed source
• Replaces. MasterControl, Veeva Vault QMS

SimplerQMS is the product of SimplerQMS A/S, entered in the Danish register under CVR number DK39039923 with an address at Nannasgade 28 in Copenhagen. The privacy policy names the Danish Data Protection Agency as supervisory authority, and the company was started by former managers of the Danish device maker Ambu. The vendor holds an ISO 13485:2016 certificate and states controls from ISO/IEC 27001:2022, which gives a procurement team something to check without a questionnaire.

The software is described as delivered validated according to ISPE GAMP 5, and the pricing page puts implementation, onboarding, validation, user training and cloud hosting inside the subscription. The Starter tier is shown from USD 17,500 a year for up to 15 users, and invited auditors get a free read-only Viewer licence. Hosting uses Amazon Web Services and Microsoft Azure, so the Danish entity sits on US-parented infrastructure.

Standout feature. SimplerQMS is the one vendor on this page that holds an ISO 13485:2016 certificate itself and puts the validation work in the subscription.

#3 Scilife

Brussels, Belgium Free trial; tiers Essential, Core and Core+ are priced on request Demo on request

Best for: GMP and GDP teams that begin with documents and training and bring in CAPA in a later step

• Operating company. Scilife N.V.
• Jurisdiction. EU (Belgium)
• Where the data sits. European or US data centre, with a European one on request, according to the vendor
• Source code. Closed source
• Replaces. MasterControl, Veeva Vault QMS

Scilife is run by Scilife N.V., whose site footer names an EMEA office at Kantersteen 47 in Brussels and a separate Scilife Inc office in New York. The company sells to pharma, biotech, medical device, healthcare logistics and cannabis firms and structures the product as a ladder. Essential holds document management, training, competences, records and KPIs, Core adds CAPAs, change control and quality events such as deviations and complaints, and Core+ is the all-in-one tier.

A separate product handles controlled printing and reconciliation of paper copies, aimed at production floors that still work from printed instructions. The pricing FAQ says GDPR-bound customers receive a European data centre, while the security page says the platform runs in a virtual private cloud on Amazon AWS with encryption in transit and at rest. The terms page does not name the contracting company, so the order form should. Every tier is priced on request, with a free trial available.

Standout feature. Scilife is the only tool on the page with a dedicated controlled-printing product for paper copies of controlled documents.

#4 OpenRegulatory (Formwork)

Weinheim, Germany Free edition; Starter at 99 euros a month; QMS + Techdoc at 499 euros a month, plus VAT Demo on request

Best for: Founder-led device companies that need both a QMS and a technical file with no quality department

• Operating company. OpenReg GmbH (OpenRegulatory)
• Jurisdiction. EU (Germany)
• Where the data sits. Hosted in France and Germany, according to the vendor
• Source code. Closed source
• Replaces. MasterControl, spreadsheets and Jira-based QMS setups

OpenRegulatory sells Formwork through OpenReg GmbH, whose imprint gives Kapellenstr. 6 in Weinheim, entry HRB 757780 at the Amtsgericht Mannheim and Dr. Oliver Eidel as managing director. The company grew from free open templates for medical device regulation, and Formwork is the paid tool built on them. Its eQMS combines document control, 21 CFR Part 11 e-signatures, training and CAPA with technical documentation, risk management and usability tracking.

Prices are readable: a free Community Edition with 5 seats, Starter at 99 euros a month or 1,089 euros a year, and QMS + Techdoc at 499 euros a month or 5,489 euros a year with unlimited seats, plus VAT.

Requirements, risks and tests sit in one trace tree, with ISO 13485, IEC 62304, ISO 14971 and IEC 62366 templates preloaded and an AI step drafting SOPs for review. The FAQ states hosting in France and Germany without Amazon, Google or Microsoft, and the tool is not available self-hosted.

Standout feature. OpenRegulatory (Formwork) is the only entry that prices a QMS from zero and states that no US hyperscaler hosts the data.

#5 Cognidox

Cambridge, United Kingdom Yearly subscription by user tier, starting at 6,000 pounds Demo on request

Best for: Hardware and device developers whose product history already sits in documents and phase gates

• Operating company. Cognidox Limited
• Jurisdiction. United Kingdom (adequacy decision, outside the EEA)
• Where the data sits. The pages checked do not name a data location
• Source code. Closed source
• Replaces. MasterControl, SharePoint-based document control

Cognidox is operated by Cognidox Limited at Eagle Labs, 28 Chesterton Road, Cambridge, registered in England under number 06506232. The privacy policy, updated on 8 October 2026, says the company is a wholly owned subsidiary of Recur Software Technologies Inc., so a British contract sits under a parent outside Europe. The product began as document management and the vendor describes the package as a Lean eQMS, adding CAPA, supplier management and a business management system view around the store.

Tiers are Starter with 5 users, Growth with 30, Scale with 50 and Pro with 100, and yearly plans start from 6,000 pounds. Growth adds e-signatures and a free migration of 500 documents, while Scale adds a DocuSign integration, a learning management system and API access. The design controls module records each phase gate of a development project. Data location is not stated, and there is no manufacturing execution.

Standout feature. Cognidox builds its eQMS outward from a document store and ties design controls to the phase gates of a product project.

#6 Babtec

Wuppertal, Germany Quoted on request Demo on request

Best for: Automotive, electronics and machinery suppliers working to IATF 16949, VDA and AIAG rules

• Operating company. Babtec Informationssysteme GmbH
• Jurisdiction. EU (Germany)
• Where the data sits. The pages checked do not name a hosting model
• Source code. Closed source
• Replaces. MasterControl (for plant quality), spreadsheets for FMEA

Babtec is the product line of Babtec Informationssysteme GmbH, Clausenstrasse 6 in Wuppertal, registered at the Amtsgericht Wuppertal under HRB 10259. The homepage mentions around 1,300 customers, more than 230 staff and over 30 years of project experience, all vendor figures. The range splits into quality assurance (control plans, FMEA, in-production inspection, SPC) and management systems (requirements, document control, process management), so a supplier can keep process FMEAs and ISO documentation with one vendor.

The vendor points automotive and aerospace suppliers to DIN EN ISO 9001, IATF 16949 and the AIAG and VDA guidelines, and electronics makers to IPC and VDE requirements. A new ISO/IEC 27001 certification is announced. An AI assistant called Quorix is described as in preparation, so it does not count yet. Price, hosting model and founding year are not stated on the pages checked.

Standout feature. Babtec sells FMEA and control plans as products of their own, next to its document and process tools, for supplier rules such as IATF 16949.

#7 CAQ AG

Rheinboellen, Germany Quoted on request; a maintenance contract covers updates and support Demo on request

Best for: Plant quality departments that want inspection and management modules on a single data model

• Operating company. CAQ AG Factory Systems
• Jurisdiction. EU (Germany)
• Where the data sits. Left to the customer: SaaS or on-premises, according to the vendor
• Source code. Closed source
• Replaces. MasterControl (plant quality), separate CAQ tools

CAQ AG Factory Systems publishes its imprint at In der Wester 5, 55494 Rheinboellen, with Florian and Sebastian Schwarz on the executive board, and says CAQ.Net has been in use since 1993. The suite starts from inspection: initial sample inspection, gauge management and maintenance, then reaches upward into process, document, training and change control, audits, suppliers, risk and complaints. The vendor describes a continuous information flow between the line and management software.

Listed core tools are APQP, control plan, FMEA, MSA, SPC, PPAP and layered process audits, with interfaces named for SAP, ARBURG, ALS and CAD systems. The software is described as fully configurable with a no-code designer, multitenancy, multilingual operation and floating licences, and validation capability is part of every solution. It runs as SaaS or on-premises, prices are on request and a maintenance contract covers updates and support.

Standout feature. CAQ AG is the only vendor on the page that offers its quality suite on the customer's own servers as well as SaaS.

#8 Ideagen

Nottingham, United Kingdom Quoted on request Demo on request

Best for: Large organisations that want quality, EHS and compliance processes under one supplier

• Operating company. Ideagen plc
• Jurisdiction. United Kingdom (adequacy decision, outside the EEA)
• Where the data sits. The pages checked do not name a data location
• Source code. Closed source
• Replaces. MasterControl, Veeva Vault QMS

Ideagen plc is registered in England and Wales under number 02805019, with its registered office at One Mere Way, Ruddington, Nottingham, according to its terms of use.

Quality is one of three families on the group site, next to EHS and compliance, so quality records can be shared with audit and risk modules. The quality product runs document control, CAPA, audits, training, supplier quality and inspection management on one platform, and change management follows changes in ISO standards and regulations into workflows.

The product page names ISO 9001 including the 2026 edition, ISO 13485, 21 CFR Part 11, AS9100 and IATF 16949 as built in, which are vendor statements to map clause by clause during an audit. Customer stories name Nuffield Health, South Tees NHS and Torbay Pharmaceuticals. No price is published, hosting is not stated, and the pages offer demos and an ROI calculator in place of a price list.

Standout feature. Ideagen ties regulatory intelligence about changes in standards directly into its quality workflows and shares records with EHS and compliance modules.

#9 Orcanos

Ramat Gan, Israel Quoted on request Demo on request

Best for: Device companies whose developers and quality staff currently work in separate tools

• Operating company. Orcanos Ltd.
• Jurisdiction. Israel (outside the EU/EEA)
• Where the data sits. The pages checked do not name a data location
• Source code. Closed source
• Replaces. MasterControl, Jira plus separate QMS

Orcanos is run by Orcanos Ltd., which its privacy policy names as database owner under Israeli privacy law, with offices at 4 Ariel Sharon Street in Ramat Gan. Israel counts as European for this directory. The platform has three modules: a regulated ALM for requirements, risk, tests and defects, an eQMS, and an AI assistant called Ask Paul. The vendor says every design change is assessed automatically for its quality and compliance impact, because both sides use one data layer.

The eQMS covers document control with 21 CFR Part 11 signatures, CAPA, complaints, audits, suppliers and training with automatic assignments. The vendor quotes go-live in 14 days with templates and 24 days on average, which are vendor claims. Jira, GitHub and Azure DevOps are integrated, and ISO 14971 risk is covered. The terms of use date from May 2019 and the copyright line reads 2023. Prices and hosting are unpublished.

Standout feature. Orcanos is the only vendor on the page that bundles a regulated application lifecycle tool for requirements and tests with its eQMS.

#10 isoTracker

Oxted, United Kingdom Subscription per module; the checkout page names GBP, USD and EUR but showed no amounts to the crawler Demo on request

Best for: Small and mid-sized firms aiming at ISO 9001 or ISO 13485 certification that add modules over time

• Operating company. isoTracker Solutions Ltd
• Jurisdiction. United Kingdom (adequacy decision, outside the EEA)
• Where the data sits. The pages checked do not name a data location
• Source code. Closed source
• Replaces. MasterControl, shared-drive ISO systems

isoTracker is sold by isoTracker Solutions Ltd, registered in England and Wales under number 4621066, with its address at Downsview House, Station Road East, Oxted, Surrey, and a US representative office in Michigan. Customers subscribe and pay only for the modules they use: documents, complaints, audits, CAPA, non-conformance and risk. Licences can be named or concurrent, which helps when many people read documents but few are logged in together.

A 60-day trial of the full version runs without a credit card, and data entered during the trial carries over to a subscription. Workflow email reminders, action traceability and daily backups are standard. Landing pages exist for ISO 9001, 13485, 14971, 17025, 22000, 45001 and IATF 16949. The pricing page has 5, 10, 20 and 30 user options, but its figures were not readable to the crawler, so no amount is quoted, and no hosting location is stated.

Standout feature. isoTracker offers a 60-day full-version trial that keeps the entered data when the customer subscribes.

#11 ConSense

Aachen, Germany Quoted on request Demo on request

Best for: German-speaking organisations that run quality and information security under one process model

• Operating company. ConSense GmbH
• Jurisdiction. EU (Germany)
• Where the data sits. The pages checked do not name a data location
• Source code. Closed source
• Replaces. MasterControl (for process-based QMS), shared-drive handbooks

ConSense is provided by ConSense GmbH, Kackertstrasse 11 in Aachen, with Dr. Iris Bruns, Dr. Stephan Killich and Dr. Alexander Kuenzer as managing directors and an entry at the Amtsgericht Aachen. The platform is modular. Use cases on the site include quality management, information-security management, GRC, integrated management systems, document and knowledge management, forms management and a GxP validation management case for regulated industries.

Listed sectors are social services, medical, pharma, energy, transport and logistics, and production, a wider spread than the life-science focus of most eQMS vendors. The company runs an Academy with seminars, webinars, workshops and eLearnings, plus an annual user event called ConSense EXPO. The English version of the site returned a not-found page when checked, so most material is German. Prices, hosting and certifications were not verified.

Standout feature. ConSense combines quality and an information-security management system in one process-handbook platform, documented first in German.