Define functional and technical requirements for a quality management system before approaching vendors.
Quality & Productivity
Selecting and Rolling Out Quality Management System Software
Learn to evaluate eQMS vendors, migrate legacy quality records, configure document control and CAPA workflows, and drive adoption across departments.
🗓️Duration5 training days
📚Content4 modules · 8 sessions
🎓On completionAccredited attendance certificate
About the programme
Course Overview
Many organisations still run quality management on spreadsheets and shared drives, so records go missing and corrective actions slip past their deadlines whenever an audit or inspection arrives without warning. This course equips quality and IT professionals to select and roll out a quality management system with confidence. Participants learn to gather requirements from document control, CAPA and audit process owners, score competing eQMS vendors on a weighted matrix, and configure workflows that mirror how the organisation actually approves documents and closes corrective actions. Sessions cover data migration planning, system validation for intended use, and change management activities that drive real adoption rather than a system nobody logs into. By the end, participants can lead a selection and implementation project from business case through to measured post-go-live performance.
Expected Learning Outcomes
Score competing eQMS vendors against a weighted evaluation matrix covering functionality, cost and support.
Map current document control, CAPA and audit processes onto configurable software workflows.
Plan a data migration approach that preserves record integrity and revision history.
Validate a quality management system for its intended use, including electronic signature requirements.
Design training and change management activities that drive adoption across departments and sites.
Establish key performance indicators that show the software is improving quality cycle times.
Who Should Attend
Quality managers leading digital transformation of quality processes
IT project managers supporting quality system implementations
Document control and CAPA process owners
Quality directors evaluating enterprise software investments
Regulatory affairs staff needing validated electronic systems
Continuous improvement leads standardising quality processes across sites
Course Modules
Select any module to see its sessions and points.
01Defining Requirements and Evaluating Vendors
2 sessions · 8 points
Session 1Gathering Business and User Requirements
- Interview document control, CAPA and audit process owners to capture current pain points and must-have features.
- Prioritise requirements using a must-have, should-have, could-have framework before writing a request for proposal.
- Map integration needs with existing ERP, LIMS or training record systems.
- Estimate user numbers, sites and languages to size the licensing model correctly.
Session 2Comparing and Selecting a Vendor
- Build a weighted scoring matrix covering functionality, configurability, cost and vendor support.
- Run structured vendor demonstrations using scripted scenarios drawn from real quality records.
- Check vendor references for implementation timelines, uptime history and support responsiveness.
- Negotiate contract terms covering data ownership, exit clauses and future price increases.
02Configuring Core Quality Workflows
2 sessions · 8 points
Session 1Document Control and Training Record Workflows
- Configure document numbering, versioning and approval routing to match existing authority levels.
- Set periodic review triggers and automatic obsolescence of superseded documents.
- Link document revisions to mandatory retraining and record employee acknowledgement.
- Design access controls that restrict editing rights while keeping documents easy to find.
Session 2CAPA and Audit Management Workflows
- Configure CAPA workflow stages from initiation through root cause analysis to effectiveness check.
- Set escalation rules that flag overdue corrective actions to process owners and managers.
- Build audit schedules, checklists and finding-tracking workflows inside the same platform.
- Link CAPA records to related audit findings, complaints and non-conformance reports for traceability.
03Data Migration and System Validation
2 sessions · 8 points
Session 1Migrating Legacy Quality Records
- Classify legacy records by type to decide which need full migration versus archiving.
- Cleanse and de-duplicate document and CAPA data before loading it into the new system.
- Reconcile migrated record counts and revision history against the legacy source.
- Run a migration dry run with a representative sample before the full cutover.
Session 2Validating the System for Intended Use
- Write validation protocols covering installation, operational and performance qualification.
- Test electronic signature and audit trail functionality against regulatory expectations.
- Document configuration settings so the validated state can be reproduced after updates.
- Obtain sign-off from quality and IT before releasing the system to end users.
04Driving Adoption and Measuring Impact
2 sessions · 8 points
Session 1Change Management and Training Rollout
- Identify champions in each department to support peers during early use of the system.
- Design role-based training that reflects each user group's daily tasks in the new system.
- Run a phased rollout by site or department to manage support workload.
- Collect early user feedback and fix configuration issues before wider rollout continues.
Session 2Measuring Performance After Go-Live
- Track CAPA cycle time, document approval time and overdue actions before and after rollout.
- Monitor user adoption metrics such as login frequency and self-service record creation.
- Run a post-implementation review against the original business case benefits.
- Plan a continuous improvement backlog for further workflow configuration and integration.
What the participant receives
4 course modules
A structured syllabus
8 training sessions
across 5 days
32 detailed points
Applied, detailed content
Accredited attendance certificate
On completing the programme
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