From Guidance to Practice: Navigating Data Integrity Under EU Annex 11, Annex 22 Draft & FDA Regulations

The integrity of data generated, processed, and stored within GxP-regulated environments sits at the heart of pharmaceutical compliance. As regulatory frameworks continue to evolve — and as digital transformation accelerates across the industry — organisations face mounting pressure to ensure that every data point created throughout the product lifecycle is attributable, legible, contemporaneous, original, and accurate (ALCOA+).

This three-session webinar, From Guidance to Practice, is designed to bridge the gap between regulatory text and real-world implementation. Drawing on the requirements of EU Annex 11 (Computerised Systems), the newly drafted EU Annex 22 (Management of Data and Records), and the FDA's evolving guidance on data integrity and computer software assurance, the programme offers practitioners a structured, expert-led pathway through the regulatory landscape.

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Each session has been architected to deliver standalone value while collectively forming a complete learning journey — from foundational regulatory interpretation, through practical system validation and audit readiness, to the emerging governance challenges posed by Artificial Intelligence and Machine Learning in regulated settings.

The webinar is led by seasoned practitioners with hands-on inspection and implementation experience, ensuring that content goes beyond theory and equips attendees with actionable tools, frameworks, and insights they can apply directly within their organisations.

Cross-Series Outcomes:

• Build a comprehensive regulatory intelligence map spanning EU Annex 11, Annex 22 Draft, and FDA data integrity requirements
• Access practical templates, checklists, and decision frameworks applicable immediately within your organisation
• Develop a risk-based, inspection-ready data integrity programme adaptable across manufactur-ing, quality, and clinical environments

This webinar is equally valuable for professionals at pharmaceutical manufacturers, CROs, CDMOs, medical device companies, and life sciences consultancies operating under GxP regulatory frameworks