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Any Life Science organization should check the compliance of its computer systems.

Combine the core skills in systems validation and FDA, EMA, and MHRA regulatory compliance with the knowledge needed in the Life Sciences vertical, and you get the ideal Computer Systems Validation Expert you need for your organization.

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.

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)

Leverage Knowledge on Systems Validation

Any Life Science organization should check the compliance of its computer systems.

Computer Systems Validation Core Skills

Vertical Skills

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Leverage
Knowledge on
Systems Validation