Validation des Systèmes Informatisés
Computerized System Validation (CSV) is the comprehensive documented process assuring that a computerized system does exactly what it is designed to do in a consistent and reproducible manner. The validation process begins with the system proposal and continues until system retirement and retention of the e-records based on regulatory rules.
The cost and time associated with validation of computerized systems can represent a significant part of the overall system implementation budget. To streamline the validation process and also pass smoothly inspections and audits, Akility strongly recommends to follow the GAMP 5 guidelines. This risk-based approach, which is at the core of Akility's validation service offering, allows to focus validation efforts on high-risk areas and reduce the validation burden without compromising quality.
Akility has a significant experience in the validation of the following systems :
- Medical Information systems;
- Pharmacovigilance systems;
- QC laboratories systems;
- SAP modules.