Curriculum
- 6 Sections
- 27 Lessons
- 1 Day
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- Setting the Context – Why Digital QMS?4
- Core Components of a Digital QMS5
- 2.1Document Management Systems (DMS) & electronic signatures (21 CFR Part 11, Annex 11)
- 2.2Deviations, CAPA & change management digitization
- 2.3e-QMS platforms (TrackWise, MasterControl, Veeva, etc.)
- 2.4Data integrity (ALCOA+ principles in digital systems)
- 2.5Exercise: Mapping manual vs. digital workflows
- Risk-Based & Data-Driven QMS4
- Integration with Enterprise Systems4
- Digital Transformation Challenges & Enablers5
- 5.1Barriers: legacy systems, cultural resistance, validation overhead
- 5.2Enablers: AI/ML, blockchain for audit trails, IoT sensors for equipment monitoring
- 5.3Regulatory acceptance: FDA, EMA, MHRA guidance on digital QMS
- 5.4Role of leadership & quality culture in successful adoption
- 5.5Case study: Successful digital QMS transformation journey
- Future-Ready QMS5
- 6.1Intelligent QMS (iQMS) – automation, self-learning systems
- 6.2From compliance to strategic advantage: QMS as a business enabler
- 6.3Best practices for implementation roadmap: assessment → pilot → scale-up
- 6.4Building a digital QMS transformation roadmap for your organization
- 6.5What problems can digital QMS solve in your function?
Building a digital QMS transformation roadmap for your organization
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