Expertise Validation & Testing Computer System Validation

Computer System
Validation

Ensure your computer systems meet stringent regulations with Agidens’ Computer System Validation services, guaranteeing continuity, reliability and data integrity. We can provide support tailored to your needs to help you achieve your goals.

Our experts are familiar with the refinements and details of the relevant regulations, guiding you safely to your objective. Our expertise is based on many years of successful implementation and validation of GxP-CSV projects for both on-premises and cloud-based systems, such as ERP and MES.

 

COMPUTER SYSTEM VALIDATION (CSV) & GAMP 5

Agidens efficiently supports you in implementing the requirements for computer system validation (CSV) in GLP (Good Laboratory Practice), GCP (Good Clinical Practice), GMP (Good Manufacturing Practice), GDP (Good Distribution Practice), and for medical devices.

In the area of GCP, GMP, and GDP, the ‘Good Automated Manufacturing Practice 5’ (GAMP 5 & GAMP 5 2nd Edition) guide by the International Society for Pharmaceutical Engineering (ISPE) is widely recognized as a guideline for practical implementation.

The complexity and criticality of the system determine the specific checks within the overall validation process, which are assessed through a risk-based approach.

 

The ultimate guide for taking a thorough and structured approach to CSV is undoubtedly ISPE’s GAMP5. These guidelines describe procedures and principles by which you can demonstrate that your pharmaceutical products are continuously of the highest quality. This is only possible if you validate all stages in the production process. Moreover, the guidelines apply to any computer system that generates data used to make quality decisions or report to the Regulating Authorities.

Liesbeth Fleerakkers SMO Director Validation Services

TAKE YOUR CSV TO
THE NEXT LEVEL

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