EU GMP Annex 11 Draft – What Is Changing and How It Impacts Computerized Systems
EU GMP Annex 11 Draft
What Is Changing and How It Impacts Computerized Systems
Free webinar | in English | via Zoom
04/MAR/2026
*Duration: 60 minutes
This webinar will provide an overview of the EU GMP Annex 11 draft revision, focusing on its impact on computerized systems, validation strategies, data integrity, and modern digital environments within regulated industries.
The session is designed to help organizations understand what is new and how to prepare in a pragmatic and risk-based way.
What will be covered:
- Regulatory context and rationale
- Key changes and expectations
- Impact on validation and CSV practices
- Impact on modern technologies
- Roles and responsibilities
- Inspection readiness
- Practical recommendations
Who should attend:
- Quality Assurance and Compliance professionals
- CSV / CSA specialists
- IT and Digital Transformation leaders
- Validation, Data Integrity, and Regulatory Affairs teams
- Companies operating GxP computerized systems under EU GMP
Who is organizing this event?
FIVE Validation provides a digital validation platform for Life Sciences companies, accelerating validation studies by up to 7x through streamlined, efficient execution. This capability is critical for pharmaceutical, biotechnology, and medical device organizations that must demonstrate compliance with regulatory expectations from agencies such as the EMA, FDA, and ANVISA.
The company also delivers specialized services for the validation of computerized systems (including AI/ML and traditional technologies), equipment qualification, utilities qualification, and IT/OT infrastructure qualification. With a proven track record of supporting +230 clients across +1,000 validation projects, FIVE Validation complements its platform and services with FIVE Academy, offering structured training to strengthen teams’ validation capabilities.
FIVE Validation provides a digital validation platform for Life Sciences companies, accelerating validation studies by up to 7x through streamlined, efficient execution. This capability is critical for pharmaceutical, biotechnology, and medical device organizations that must demonstrate compliance with regulatory expectations from agencies such as the EMA, FDA, and ANVISA.
The company also delivers specialized services for the validation of computerized systems (including AI/ML and traditional technologies), equipment qualification, utilities qualification, and IT/OT infrastructure qualification. With a proven track record of supporting +230 clients across +1,000 validation projects, FIVE Validation complements its platform and services with FIVE Academy, offering structured training to strengthen teams’ validation capabilities.
Speaker
Silvia Martins is an electrical engineer with over 23 years of experience in the pharmaceutical, biotechnology, and medical device industries. She has received specialized training in GAMP5® and FDA 21 CFR Part 11 in England, SAP® validation in Germany, and gained expertise in data integrity and governance in Denmark.
As the CEO and co-founder of FIVE Validation, a company dedicated to simplifying compliance processes, Silvia focuses on optimizing and streamlining client procedures while ensuring robust and compliant solutions.
*The event is B2B and participation is limited to registrants with corporate email addresses.
**Submitting the form does not guarantee registration. FIVE Validation reserves the right to reject applications from professionals using personal emails, from those not aligned with the company’s mission and vision, or at its sole discretion. Registration will only be valid upon receipt of a confirmation email.
