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Validation departments are constantly expected to perform more validation projects and meet higher regulatory expectations with fewer resources. Validation departments are asked to produce quantitative measurements to document their own progress and ability to continually improve. FastVal allows you to control your validation process, increasing the quality of validation deliverables and decreasing the time required to produce these documents.
FastVal was created by experts in validation and electronic records compliance. FastVal is designed to incorporate all quality guidelines, including GAMP 5 and ICH best practices for validation, and to seamlessly integrate with your established company SOPs, guidelines, and templates for validation. Validation deliverables can be approved and stored within FastVal, or exported (in .doc or .pdf formats) and seamlessly integrated into your document management process. FastVal:
FastVal allows users to execute test protocols electronically. Instead of Testers keeping up with dozens of attached screen shots, FastVal automatically integrates this data into the final testing document. If deviations are identified, a Deviation Report is automatically created. Quality Assurance has the ability to investigate, review, and track deviations in real-time.
Electronic protocol execution with FastVal provides your organization with test protocols that are easier to read and review, reducing the amount of time that Quality needs to review validation testing and providing auditors with a clear understanding of your validation process. The executed protocol is easier and less costly to store and maintain than binders of hand-written test cases with screen shots. FastVal provides your organization with control over validation testing, indicating exactly who executed which test case steps, in what order, and how much time it took to execute each step.
FastVal is compliant with 21 CFR 11 and Annex 11 requirements for using electronic records and electronic signatures. Electronic signatures are used to verify the identity of testers, and a complete 21 CFR 11 audit trail documents the protocol execution.