Computer Systems Validation Core Skills
Based on scientific methods, processes, algorithms, and systems, Computer Systems Validation core skills help Life Sciences organizations in compliance and regulatory requirements.- Enterprise System Change Management
- IT Governance
- Technical Writing
- IT Service Management Communications
- Incident/Problem/Change Management
- User Access and Cyber Security Administration
- Validation Plan (VP), IQ, OQ, PQ, Validation Summary Reports
- Requirement Traceability Matrix (RTM)

Vertical Skills
Our Computer Systems Validation Experts have all the core skills in Data Science combined with these skills in the Life Sciences sector.- FDA 21 CFR Part 11, 58, 210, 211, 820; ISO 13485, 14971; GAMP 4, GAMP 5; GLP, GCP and cGMP
- EudraLex Volume 4 Annex 11: Computerised Systems (European Annex 11)