COMPLIANCE ADVISORY
ISPE GAMP 5 — A Risk-Based Approach to Compliant GxP 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 ISPE GAMP 5 — A Risk-Based Approach to Compliant GxP Computerised Systems
GAMP 5 (Good Automated Manufacturing Practice, 2nd Edition 2022) is an industry guideline published by ISPE (International Society for Pharmaceutical Engineering). It provides a risk-based approach to the validation and management of computerised systems in the regulated life sciences industry. GAMP 5 is the de facto standard for computerised system validation (CSV) globally. The 2022 revision introduces Critical Thinking and simplifies approaches for modern systems including cloud, SaaS, and AI/ML. Covers the complete system lifecycle and applies to GMP, GLP, GCP, and pharmacovigilance.
Most consultants approach ISPE GAMP 5 — A Risk-Based Approach to Compliant GxP 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 ISPE GAMP 5 — A Risk-Based Approach to Compliant GxP Computerised Systems doesn't exist in isolation. Ivanka will map your current compliance posture against the 17 controls across 4 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 ISPE GAMP 5 — A Risk-Based Approach to Compliant GxP 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 4 domains. She maps what you can leverage from existing compliance work and what requires new investment.
ISPE GAMP 5 — A Risk-Based Approach to Compliant GxP Computerised Systems maps to 402 other frameworks. Ivanka shows you where a single control implementation can satisfy multiple regulatory requirements at once.
Domains covered in ISPE GAMP 5 — A Risk-Based Approach to Compliant GxP Computerised Systems
This is for you if
- You need to achieve ISPE GAMP 5 — A Risk-Based Approach to Compliant GxP 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 ISPE GAMP 5 — A Risk-Based Approach to Compliant GxP 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