Process Production Operations

Empowering production operations in process industries to shorten time to market and maximize profitability by leveraging process and quality data

Validation Readiness of BIOVIA Discoverant

Each function and module in the BIOVIA Discoverant application has been developed for use in your regulated environment. Unlike most analysis and visualization tools, you can use results from BIOVIA Discoverant directly to support critical process decisions without the need for alternative validated confirmation.

Because the core functionality of BIOVIA Discoverant is fully documented and tested by BIOVIA as part of our comprehensive quality system, only your product- and process-specific data models and data capture forms require validation on-site. BIOVIA performs extensive testing on all of its products using the same discipline to develop, execute and document test scripts, protocols and product testing as required by FDA guidelines.

Validation Kit

To support your on-site validation, BIOVIA offers a Validation Kit containing key templates and protocols that will reduce the effort required to develop your validation approach. In addition to BIOVIA’s internal test documentation, the kit includes:

  • Validation plan template
  • Installation qualification protocol
  • Operational qualification protocols
  • Comprehensive system requirements
  • Executed OQ and algorithm verification evidence
  • System traceability matrix

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