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Ofni Systems uses proprietary tools to analyze the web application to create comprehensive design specifications.
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Once requirements have been outline and documented, Test Plans are developed to demonstrate that all required system functionality is met and the application is properly secured.
Our validation professionals will document a testing protocol designed to demonstrate that your form meets all of your business requirements and regulatory requirements outlined by 21 CFR Part 11.
Web-based applications and pages provide a unique method of sharing applications and information between various sites.
This relative ease of accessing information provides a unique set of challenges in validating these systems for Gx P use.
Automated tools for expert system verification are reviewed.
Considerable attention is then given to the issues in structuring the validation process, particularly the establishment of the criteria by which the system is judged, the need to maintain objectivity, and the concept of reliability.The systems engineering life-cycle model may be described differently by MITRE's government sponsors.The Department of Defense (Do D) sponsor uses the Do D 5000.02 process to describe a "five stage" systems engineering life cycle .MITRE SEs are expected to participate in developmental and operational testing; observe, evaluate, and communicate test results; influence retest decisions; recommend mitigation strategies; and assist the sponsor in making system acceptance decisions.They are expected to evaluate test data and verify that requirements and specifications are met and validated to confirm operational capabilities.As appropriate, this includes operational qualifications (OQ) and performance qualifications (PQ).