> QMS software requirements checklist with more than 60 criteria on document control, training, CAPA, standards, security and cost – ready as an RFP basis and PDF. Source: [https://docxpert.io/en/checklists/qms-software-selection](https://docxpert.io/en/checklists/qms-software-selection) # QMS Software Requirements Checklist: 60+ Criteria Save as PDF Print-ready version with tick boxes. [Get the PDF](https://docxpert.io/en/checklists/qms-software-selection#download) ## How to use this checklist 1. 1 Define must-haves and nice-to-haves Go through the list with quality, IT and one business department and mark what is essential. Fewer must-haves make the comparison clearer. 2. 2 Pre-filter vendors Send the must-haves to three to five vendors. Anyone who does not answer clearly drops out. 3. 3 Test with real scenarios In the demo or trial, test your own processes: approve a document, assign a training, record a deviation. 4. 4 Compare total cost Compare licence, implementation, data migration, training and internal effort over three years. Detailed advice is in our guide on [how to choose QMS software](https://docxpert.io/en/guides/choosing-qms-software). ## Requirements catalogue ### Document control - Manage documents with number, version, status and validity. - Single and dual-stage approvals with reviewer and approver. - Approval rules configurable per document type. - Automatic versioning with change reason and version comparison. - Review cycles with reminders before they are due. - Access rights by role, department and person. - Read and understood confirmation for new versions, with evidence. - Controlled printouts that can be verified, and withdrawal of invalid documents. - Consistent layout with header and footer and PDF export. - Full-text and semantic search across all documents. - Import of existing documents (Word, PDF, Excel, SharePoint). ### Training and competence - Assign training automatically by role, department or person. - Online training with knowledge check. - Classroom training with attendance and attendance list. - Upload external evidence (certificates). - Training matrix with export. - Reminders, escalation and refreshers before expiry. - Retraining when a document version changes. - Training effectiveness evaluation. ### Improvement and deviations - Record and assess deviations and nonconformities. - CAPA workflow with root cause analysis (5 Whys, Ishikawa). - Deadlines by severity and escalation. - Effectiveness check before closure. - Links between deviation, CAPA, document and training. - Task overview per person. ### Standards and compliance - Support for the relevant standards (e.g. ISO 9001, 13485, 14001, 45001, 27001). - Several standards in one integrated management system. - Templates for mandatory documents per standard. - Gap analysis against standard requirements. - Traceability from requirement to evidence. - Monitoring of regulatory changes. - Support for regulatory topics such as NIS2 or the EU AI Act. ### Evidence and integrity - Complete, tamper-evident audit trail. - Audit trail export (CSV, PDF). - Re-authentication before approvals (electronic signature). - Archived versions that cannot be changed. - Retention periods and archiving. ### AI features - AI support for drafting documents. - Questions to your own documents with source references. - AI results are marked as suggestions and approved by people. - AI answers only use documents the asking person has access to. - Transparency about which AI providers and models are used. - AI features can be switched off or controlled. ### Usability - Interface in the languages you need (e.g. English and German). - Personal inbox with all open tasks. - Usable on mobile devices, including the shop floor. - Short onboarding without lengthy training. - Guided setup for getting started. ### IT, security and data protection - Hosting location and sub-processors are transparent. - Data processing agreement under GDPR available. - Tenant separation and encryption. - Single sign-on and role model. - API for integrations. - Regular backups and restore tests. - Export of all data at the end of the contract. ### Vendor and cost - Transparent pricing without hidden costs. - Free trial with full functionality. - Support in your language with defined response times. - Transparent roadmap and update cycle. - References from your industry. - Suitable notice period and contract term. ## Download the checklist as PDF Print-ready with tick boxes – ideal for your next audit or team meeting. Free; we also email you the link. ## Frequently asked questions How many vendors should I compare? Three to five vendors are usually enough. More vendors increase the effort without improving the decision much. How long does a QMS implementation take? For SMEs a few weeks is realistic if templates can be used and documents imported. Complex data migrations and validation extend the timeline. Do I need validated software? In regulated areas such as medical devices or pharmaceuticals, computerised systems must be validated for their intended use. Ask the vendor for validation documentation. ## Read next [Choosing QMS softwareCriteria, questions for vendors and common pitfalls when selecting a QMS.Learn more](https://docxpert.io/en/guides/choosing-qms-software) [Document controlControlled documents with status, validity, review cycles and access rights – aligned with ISO 9001 clause 7.5.Learn more](https://docxpert.io/en/features/document-management) [Training managementOnline and classroom training, training matrix, reminders, records and effectiveness checks.Learn more](https://docxpert.io/en/features/training-certification) [ISO 9001Quality management: document control, competence, audits and improvement in one platform.Learn more](https://docxpert.io/en/standards/iso-9001) ## Try docxpert free for 14 days Document control, approvals, training and evidence in one platform – with English and German templates for more than ten standards. [Start free trial](https://docxpert.io/en/trial)[See pricing](https://docxpert.io/en/pricing)