Computer Systems Validation Core SkillsBased 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 SkillsOur Computer Systems Validation Experts have all the core skills in Data Science combined with these skills in the Life Sciences sector.
Computer Systems Validation Core Skills Skills in Life Sciences
- 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)