Computer System
Validation
Ensure your computerized systems meet stringent regulations with Agidens’ Computer System Validation services, guaranteeing continuity, reliability, and data integrity.
CSV offers producers documented proof of compliant, consistent computerized/automated system performance. Our services provide advice and support for achieving this goal.
WHAT IS COMPUTER SYSTEM VALIDATION (CSV)?
Computer System Validation (CSV) provides pharmaceutical producers with documented proof that their computerized or automated systems perform consistently and in compliance with all relevant regulations. These systems control and monitor automated production environments, making their reliability crucial for the success of the production process.
USA FDA 21 CFR Part 210, 211, and 11 and EudraLex Vol 4 Annex 11 describe the requirements for computerized systems in medicine production processes. These regulations apply to every computer system that generates data used to support quality decisions or to report to the FDA. GAMP5 serves as a guideline to execute CSV in a thorough and structured manner.
DATA INTEGRITY & ISO 13485
The current focus on data integrity by inspecting authorities leads to many actions in the field of computerized systems at different companies. Agidens supports this by conducting trainings, gap assessments, and impact assessments.
The most recent version of ISO 13485 emphasizes software validation. Agidens can support this with both criticality assessments and qualification of different systems, ensuring your computer systems maintain the highest level of data integrity and compliance with the latest standards.
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 FDA.
AGIDENS IS YOUR PARTNER FOR CSV
- We ensure automated systems perform consistently and comply with regulations
- Tailored to your needs: Customized or standard solutions based on project requirements and complexity
- Documented proof: Validation process demonstrates systems meet predefined specifications throughout their life cycle
- GAMP5© and V-model: Qualification approach adheres to current GxP/ISO directives and norms
TAKE YOUR CSV TO
THE NEXT LEVEL
Do you like our approach? We would love to hear from you!
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