The goal of software validation can be summarized as establishing documented evidence which provides a high degree of assurance that the system in question consistently functions as expected by meeting its predetermined specifications and quality attributes. While the FDA has set guidelines for validation, the actual specifics of how validation is performed is determined by the pharmaceutical/medical device company itself. It is widely recommend by both the FDA as well as other authorities that Risk Based Validation Approach is utilized. This means that the approach taken to validation is based on justified and documented risk assessment, with consideration to the potential of the system to affect product quality and safety and record integrity.
Validation exerts a considerable burden on the manufacturer in terms of time and resources required to fully see through a comprehensive, FDA compliant validation process. To lessen burden and speed up the validation process, Predisys provides a set of Validation Packs and professional services to assist the manufacturer perform the validation.
Predisys Validation Packs provides a set of templates, which may be used to guide and record validation activities and test protocols. The document templates included in the Validation Pack cover the entire validation process, from validation planning to the acceptance of the validated system.
The key documents included in the Predisys Validation Packs are:
- Software and Analysis Configuration
- Risk Assessment
- Installation Qualification (IQ)
- Operational Qualification (OQ)