COMPLIANCE ADVISORY
EU GMP Annex 11 — Computerised Systems Readiness Advisory
A strategy call with someone who has spent 25 years building compliance systems used by 100,000+ professionals in 160+ countries – not a generalist who read the standard last week.
Why work with Ivanka on EU GMP Annex 11 — Computerised Systems
EU GMP Annex 11 (revised 2011) provides guidance on the application of Good Manufacturing Practice (GMP) to computerised systems used in pharmaceutical manufacturing and quality control. Published by the European Commission as part of EudraLex Volume 4. Covers the complete lifecycle of computerised systems from specification through decommissioning. Key topics include risk management, validation, data integrity, electronic signatures, batch release, and cloud computing. Applicable to all computerised systems used in GMP-regulated activities.
Most consultants approach EU GMP Annex 11 — Computerised Systems as a checkbox exercise. Ivanka approaches it as a strategic lever. With 25 years of building The Art of Service – a compliance platform now covering 692 frameworks and 819,000+ cross-framework mappings – she doesn't just understand the standard. She understands how it connects to everything else your organisation is already doing.
This matters because EU GMP Annex 11 — Computerised Systems doesn't exist in isolation. Ivanka will map your current compliance posture against the 23 controls across 6 domains, identify gaps, and show you where existing controls from other frameworks you may already follow can be leveraged – saving months of redundant work.
Relevant credentials
- MIT Entrepreneurial Masters graduate – rigorous analytical approach to enterprise challenges
- EXIN Expert Panel member – helping shape global certification standards
THE STRATEGY CALL
What you get in 30 minutes
Ivanka reviews your EU GMP Annex 11 — Computerised Systems readiness scores and identifies the critical gaps that carry the highest risk. No generic advice – specific to your domains and controls.
A clear, prioritised plan for addressing gaps across 6 domains. She maps what you can leverage from existing compliance work and what requires new investment.
EU GMP Annex 11 — Computerised Systems maps to 539 other frameworks. Ivanka shows you where a single control implementation can satisfy multiple regulatory requirements at once.
Domains covered in EU GMP Annex 11 — Computerised Systems
Plus 1 additional domains. See the full assessment →
This is for you if
- You need to achieve EU GMP Annex 11 — Computerised Systems compliance but don’t know where to start or how to prioritise
- You’ve been told you’re “compliant” but suspect gaps exist that haven’t been properly assessed
- You manage compliance for organisations across every sector and need expert guidance, not generic templates
- You want to leverage existing compliance efforts across multiple frameworks rather than starting from scratch
- You need a strategic plan your leadership team and board will actually understand and support
Start with a free assessment. Then let's talk strategy.
Take the free EU GMP Annex 11 — Computerised Systems readiness diagnostic. In 5 minutes you'll have a clear picture of where your gaps are. Then book the strategy call and Ivanka will show you exactly how to close them.
Free · No login required · Results in 5 minutes
Or go directly to the $149 Report + Strategy Call