Computerised system validation is establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.
These evidentiary artifacts include, but are not limited to, a clear and concise user requirement. Validation activities extend beyond go-live, and require systems to be maintained appropriately.
Northern Life Sciences consultants will work with organisation’s SMEs and key stakeholders to ensure all key artifacts are clearly identified and properly scoped and appropriately maintained based on current regulatory requirements.
