GAMP Computer System Validation (CSV)

GAMP^® 5 provides pragmatic and practical industry guidance to achieve compliant computerized systems fit for intended use in an efficient and effective manner. Good Automated Manufacturing Practice (GAMP 5 ®) sets out principles and procedures that help ensure that pharmaceutical or medical device products have the required quality and details a recognized standard for Computer system validation (CSV).

Computer System Validation (CSV) is a documented process that is required by regulatory agencies around the world to verify that a computerized system does exactly what it is designed to do in a consistent and reproducible manner. These regulatory agencies require CSV processes to confirm the accuracy and integrity of data in computerized systems in order to ensure product safety and effectiveness. In the United States, for example, the FDA requires pharmaceutical companies to perform CSV for systems that support the production of:

• Pharmaceuticals
• Medical Devices

Best Practices for Computer System Validation

• Develop Clear and Precise Functional and User Requirements
• Perform risk-based CSV.
• Create a detailed Validation Plan.
• Create a Team with knowledge of regulatory guidelines/compliance, validation procedures, laboratory processes, and the technology
• Document thoroughly.
• Audit third-party Providers.

With our experienced consultants, including staff who have developed and tested safety critical software, itsbusiness supports you in the development of robust software quality assurance, carries out an assessment together with you for a TARGET/ACTUAL analysis, and submits an action plan as well as for the implementation. Within the scope of the implementation, we support you in the implementation of the action plan and ensure the achievement of the objectives.

Contact

If you have questions or need more information, please contact:

Andrew Connell​
QA Consultant, itsbusiness AG
+41 31 370 32 05
andrew.connell@itsbusiness.ch​