BIOVIA Discoverant has been developed for use in regulated environments. Unlike most analysis and visualization tools, you can use results from BIOVIA Discoverant to support critical process decisions without further validation. The system supports CSA. This is a set of activities performed to ensure that the software functions as intended. CSA replaces traditional Computer System Validation (CSV) with a risk-based approach focusing on the intended approach.
Validation
BIOVIA performs extensive testing on all of its products to develop, execute and document test scripts, protocols and product testing as required by FDA guidelines. As the core functionality of BIOVIA Discoverant is fully documented and tested by BIOVIA, only your product- and process-specific data models and data capture forms require validation on-site. To reduce your validation efforts, you can leverage BIOVIA’s Validation Kit. In addition to BIOVIA’s internal test documentation, this kit includes:
- Validation plan template
- Installation qualification protocol
- Operational qualification protocols
- Comprehensive system requirements
- Executed Operational Qualification (OQ) and algorithm verification evidence
- System traceability matrix
Read: Implementing a Scalable CPV Solution for CMOs
