About this webinar
Cloud-based Manufacturing Execution Systems (MES) are transforming how life sciences manufacturers manage production, quality, and compliance. However, many organizations still face uncertainty when it comes to validating cloud solutions while meeting international GMP requirements.
In this on-demand webinar, our validation and digital manufacturing experts share a practical approach to Computer System Validation (CSV) for cloud MES environments. Learn how modern validation strategies can support compliance, data integrity, and quality objectives without applying unnecessary validation effort.
Whether you are evaluating a cloud MES, planning a digital transformation initiative, or preparing for validation activities, this session provides practical guidance to help you move forward with confidence.
Session highlights
1. Why traditional validation approaches need to evolve
Understand the challenges of applying legacy CSV methodologies to modern cloud-based platforms and how organizations can adapt their validation strategies.
2. Defining responsibilities across the cloud ecosystem
Learn how responsibilities are typically shared between manufacturers, software providers, and infrastructure partners to support GMP compliance.
3. Applying risk-based validation principles
Explore practical ways to focus validation activities on critical processes, patient safety, product quality, and data integrity.
4. Ensuring data integrity in cloud MES environments
Discover key considerations for maintaining compliant electronic records, audit trails, traceability, and ALCOA+ principles.
5. Practical validation lessons from real-world projects
Gain insights from industry experience validating modern MES solutions and learn how organizations can accelerate deployment while maintaining compliance.
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Meet our speaker
David Margetts, Group Executive Director
David has extensive experience delivering GMP digitalisation, MES, validation, and manufacturing transformation initiatives across global life sciences organisations. He has supported numerous companies in implementing compliant digital systems while balancing operational efficiency and regulatory requirements.
Douglas Isles, Solution Quality Manager
Douglas specialises in Computer System Validation, quality systems, and compliance strategy for regulated industries. His practical approach helps organisations implement modern validation frameworks that align with current regulatory expectations.
Moderator: Orchun Thakral, Head of Customer Success & Sales Director
Orchun leads customer success and digital manufacturing initiatives across Asia-Pacific and global markets, helping life sciences manufacturers achieve successful digital transformation outcomes while maintaining compliance.
