Validation

Virtify’s solution development methodology ensures that all the relevant regulatory and quality requirements are met during the development of requirements, architecture design, solution implementation and rollout. Computer systems validation tasks are aimed towards completing the overall validation of systems and maintaining the validated state on a continual basis.

Virtify believes that the key to an overall validation approach is taking a system-level approach to the problem, i.e., not to just validate the individual components of the process – software, hardware, user procedures – but to treat these components as part of an overall system that needs system-level validation. In this context, Virtify approaches computer system validation as a structured activity aimed towards demonstrating and documenting that the system requirements and design intent have been achieved.

Overall, Virtify follows a computer systems validation definition that is based on the confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled. Validation activities are structured towards testing against requirements, along with validation planning that is risk-driven to account for the fact that SQA testing typically is not exhaustive.

Hence, Virtify follows GAMP recommended guidelines for mapping validation activities to the system development activities. In general, Virtify will follow a client’s corporate quality practices, SOPs, methodologies and guidelines towards the computer systems validation of solutions.