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Validating cloud MES systems for international GMP: A practical CSV approach

Are you still applying paper-era validation thinking to cloud-based manufacturing systems?

 

As life sciences manufacturers accelerate digital transformation and adopt cloud-based Manufacturing Execution Systems (MES), many traditional Computer System Validation (CSV) approaches are struggling to keep pace. Legacy validation methods can create unnecessary complexity, unclear responsibilities, and inefficient documentation processes, especially in modern cloud environments.

 

Join this practical webinar to explore how regulated manufacturers can apply a modern, risk-based CSV approach for cloud MES systems while maintaining compliance, data integrity, and inspection readiness across international GMP operations.

What you will learn: 5 things you will leave with

1. Why traditional CSV falls short for cloud MES
Understand why legacy validation approaches struggle in cloud environments—and what needs to change for modern GMP systems.

 

2. Clear roles & responsibilities in the cloud ecosystem
Learn how to define accountability across customer, software provider, and infrastructure hosting to ensure compliance and avoid gaps.

 

3. Applying risk-based CSV with confidence
Discover how to use Quality Risk Management (QRM) to focus validation on critical processes and data—reducing effort while staying compliant.

 

4. Making data integrity & compliance practical
Ensure your MES aligns with global GMP and ALCOA+ principles, with audit-ready data, traceability, and secure system design.

 

5. Real-world example: Validating a cloud MES system successfully
See how a modern MES like BatchLine MES can be validated using a practical CSV approach

Webinar Details

• Cost: Free of charge • Language: English

Speakers

David Margetts, Group Executive Director

Group Executive Director with extensive experience in GMP digitalisation, MES, validation, and regulated manufacturing transformation across international life sciences organisations.

 

Douglas Isles, Solution Quality Manager

Experienced quality and validation specialist focused on practical CSV approaches, compliance strategy, and modern GMP system validation.

 

Moderator: Orchun Thakral, Head of Customer Success & Sales Director

Leading customer success and digital manufacturing initiatives for regulated industries across Asia-Pacific and global markets.

Who Should Attend?

This webinar is ideal for professionals in GMP-regulated industries, including:

  • Manufacturing & Production
  • QA / Compliance
  • CSV / CSA & Validation
  • IT & Digital Transformation
  • Engineering & Automation
  • MES / Digitalisation Project Team

 

Modern GMP manufacturing is evolving rapidly, and validation must evolve with it. Join this webinar to explore a practical, modern CSV approach for cloud MES systems with confidence and compliance.

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