Validation

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

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

Validation Kit

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

• Validation Plan template
• User Requirements Specification template
• Design Specification template
• Installation Qualification Protocol
• Operational Qualification Protocol