AgosIT’s Computer System Validation (CSV) support packages offer peace of mind in times of heavy workload. AgosIT can support your business with its QA- CSV support functions to allow your quality team to focus all their effort on patient Safety, product quality and data integrity. Our service provides instant quality support when it’s needed without the associated cost of employing extra resource.
The CSV Support Package provides the following benefits;
- Document reviews, change management, risk analysis, RCA, deviation investigations and test management support.
- Document reviews include initial or final review of SOPs, WI, Policies and executables for compliance with applicable regulations.
- Assistance with change management and impact assessments, external quality representation for change board.
- Assistance with risk analysis and risk profiling including remediation and scoring.
- Support for deviation investigation and root cause analysis including deviation write up or approvals.
- Oversight and management of testing activities during validation or qualification projects. Including support with incident and deviation management if required.
- General QA-CSV support.