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SPECIFICTION
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Qualsys EQMS

ideagen.com

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Spec score 7.1 #17 of 26 in Document Control Software

What it is

Ideagen Qualsys is now known as Ideagen Quality Management, a cloud quality management platform for distributed teams and remote operations. It connects document control, CAPA, audits, inspections, training and competency management, supplier quality, and regulatory intelligence. Mobile-first smart forms support offline data capture, and the Android and iOS app supports incident reporting, auditing, and documentation. Workflows list ISO 9001, ISO 13485, 21 CFR Part 11, AS9100, and IATF 16949. CAPA workflows support root cause analysis and predictive insights; audit tools include automated evidence, adaptive checklists, collaboration, and findings traced to actions. Ideagen says the platform can standardize processes across sites and regions while allowing regional flexibility. Its Hub connects quality, EHS, compliance, and risk through shared data and audit trails. Every Mazlan AI output requires human review and approval. The platform lists approval workflows, electronic signatures, role-based access, version history, read acknowledgements, and completion tracking. Pricing is on request; the pages direct visitors to request a demo and do not state trial terms.

Spec sheet

What it does
The platform provides integrated quality management with mobile first smart forms and offline data capture for distributed teams and remote operations.Read 7 Oct 2026 · ideagen.com
Integrations
Ideagen says third party system integration is supported via API for its training management capabilities.Read 7 Oct 2026 · ideagen.com
Security
Ideagen states that its corporate security policies are aligned with ISO/IEC 27001:2013, to which it is externally certified.Read 7 Oct 2026 · ideagen.com
Support
The product comparison page lists 24/7 global support among Ideagen's quality management capabilities.Read 7 Oct 2026 · ideagen.com
Headquarters
Nottingham, United KingdomRead 28 Sep 2026 · ideagen.com
Founded
1993Read 28 Sep 2026 · ideagen.com
AI governance
The page says every Mazlan AI output requires human review and approval.Read 7 Oct 2026 · ideagen.com
Audit and compliance
The platform supports audit capabilities and compliance tracking across multiple locations.Read 7 Oct 2026 · ideagen.com
Audit tools
Audit management includes automated evidence, adaptive checklists, real-time collaboration, and findings traced to actions.Read 7 Oct 2026 · ideagen.com
CAPA workflows
Its CAPA workflows support systematic root cause analysis and predictive insights.Read 7 Oct 2026 · ideagen.com
Company background
Ideagen's 2022 company announcement says it was established in 1993 and headquartered in Nottingham, UK.Read 7 Oct 2026 · staging-corp-waf.ideagen.com
Core capabilities
Ideagen Quality Management includes document control, CAPA, audits, inspections, training and competency management, supplier quality management, and regulatory intelligence.Read 7 Oct 2026 · ideagen.com
Implementation
The FAQ states implementation takes 30 days to go live.Read 7 Oct 2026 · ideagen.com
Integration
The QMS page says Ideagen Hub connects quality, EHS, compliance, and risk using shared data and audit trails.Read 7 Oct 2026 · ideagen.com
Intended industries
The page identifies healthcare, pathology, pharmaceuticals, manufacturing, medical devices, and life sciences as target sectors.Read 7 Oct 2026 · ideagen.com
Maker founding year
Ideagen states that it was established in 1993.Read 7 Oct 2026 · ideagen.com
Mobile app
The Ideagen Quality Management mobile app is available for Android and iOS and supports incident reporting, auditing and documentation.Read 7 Oct 2026 · ideagen.com
Mobile data capture
The Qualsys page describes mobile-first smart forms and offline data capture.Read 7 Oct 2026 · ideagen.com
Pricing and trial
The pages reviewed direct visitors to request a demo and do not state a price or trial terms.Read 7 Oct 2026 · ideagen.com
Product purpose
Qualsys provided integrated quality management for distributed teams and remote operations.Read 7 Oct 2026 · ideagen.com
Product status
Ideagen Qualsys is now known as Ideagen Quality Management.Read 7 Oct 2026 · ideagen.com
Quality workflows
Ideagen says the QMS connects document control, CAPA, audits, training, supplier quality and inspection in one platform.Read 7 Oct 2026 · ideagen.com
Qualsys background
Ideagen's acquisition announcement says Qualsys was based in Sheffield and started in 1995.Read 7 Oct 2026 · ideagen.com
Renamed product
Ideagen Qualsys is now known as Ideagen Quality Management.Read 7 Oct 2026 · ideagen.com
Scale
Ideagen says the system supports standardizing processes across multiple sites and regions while allowing regional flexibility.Read 7 Oct 2026 · ideagen.com
Standards
The QMS page lists ISO 9001, ISO 13485, 21 CFR Part 11, AS9100 and IATF 16949 as built into its workflows.Read 7 Oct 2026 · ideagen.com
Supported standards
The page lists ISO 9001, ISO 13485, 21 CFR Part 11, AS9100, and IATF 16949 as built into the workflows.Read 7 Oct 2026 · ideagen.com
Target organizations
Ideagen presents the QMS for regulated industries and cites healthcare, manufacturing and food and beverage among its industries.Read 7 Oct 2026 · ideagen.com

Strong points and limits

Strong points

  • Mobile forms support offline data capture
  • Workflows list five named standards
  • Audit findings can be traced to actions
  • Mazlan AI outputs require human approval

Limits

  • Pricing is available on request
  • No trial terms are stated
  • AI output requires human review and approval

Who it suits

Ideagen Quality Management is aimed at organizations managing quality workflows across multiple sites, especially in regulated sectors such as healthcare, manufacturing, pharmaceuticals, and medical devices. Its mobile and offline features suit distributed or remote operations.

Verdict

Ideagen Quality Management brings a broad set of quality workflows together for distributed organizations. Buyers will need to request pricing and a demo to assess commercial terms.

Where Specifiction places it

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