Program Overview
 This program explores how organizations can modernize their Quality Management Systems (QMS) by leveraging digital tools, automation, and integration with enterprise systems. Participants will gain a deep understanding of digital QMS components, risk-based approaches, and regulatory expectations while learning from real-world examples of successful transformations. Through interactive exercises and simulations, the course emphasizes building future-ready quality systems that not only ensure compliance but also act as a strategic advantage in driving efficiency, agility, and innovation.
Features
- Understand the core components, frameworks, and digital enablers of a modern QMS
- Apply risk-based and data-driven approaches to strengthen compliance and quality outcomes
- Explore integration of QMS with ERP, LIMS, MES, and supply chain systems for enterprise-wide visibility
- Develop a roadmap to overcome barriers and implement a future-ready digital QMS in your organization
Target audiences
- Regulatory Affairs and Quality Assurance Teams
- Digital Transformation Teams
- Operations and Compliance Teams
Curriculum
- 6 Sections
- 27 Lessons
- 1 Day
Expand all sectionsCollapse all sections
- 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?
Instructor
