Computer Systems Validation (CSV) is a formal process to verify that:
- systems consistently operate as they were intended.
- user, business and regulatory system requirements are met.
- information/data is secure and properly managed by the system.
- procedures and processes are in place for the operation, management and maintenance of the system.
To achieve this involves completing (and maintaining) a validation exercise, which utilises a risk-based lifecycle (GAMP5 is the industry standard), focussing on:
- Patient Safety.
- Product Quality.
- Data Integrity.
It is important (and cost effective) to leverage as much as possible from your Suppliers (after they pass your Supplier Assessment process) during the validation exercise, which will comprise development (if applicable), design, implementation, commissioning and qualification of the system.
Computer Systems Validation applies to any software system used to make a GxP quality decision. Note that it is not a 100% test of a system.
For more information or to discuss any support you need in validating your equipment or software systems, contact us using the information in the footer of this page.