Computer System Validation
MAKE YOUR SYSTEM IN COMPLIANCE
THE VALIDATION OF COMPUTERIZED SYSTSEMS HAS TRADITIONALLY BEEN DEFINED AS A SYSTEMATIC PROCESS BASED ON DOCUMENTEND EVIDENCE AIMED AT DEMONSTRATING THAT SOFTWARE OPERATES ACCORDING TO THE SPECIFIED REQUIREMENTS AND THE EXPECTATIONS OF REGULATORY AUTHORITIES.
Our mission is to ensure that the technological systems used by companies comply with the highest standards of quality and compliance, according to current regulations.
Protect your processes, validate your systems.
CSV
Computer System Validation
Computer System Validation main actvities:
- Definition of URS requirements
- Validation Plan
- Risk Assessment
- Risk Management
- Evaluation of supplier development activities: FS, SDS, HDS
- Issuing and execution of qualification protocols (IQ, OQ, PQ)
- Validation Report
- Traceability Matrix
- Standard Operative procedure (SOP) in order to maintain the validate state of systems: access management, configuration check, periodic review, back up & restore, Disaster & Recovery
- Periodic Review
- Data Integrity Assessment
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