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Our Validation Approach:
We ensure compliance through a modern Computer Software Assurance (CSA) strategy following current FDA guidance (Feb 2026).
Using our vendor provided documentation, deploment takes weeks rather than 6+ months required for older systems built on outdated Computer Software Validation (CSV) by using test documentation that we've already executed, so you don't have to.
basic:
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Requirements Traceability Matrix (RTM)
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Data Availibility and Recovery Policy (DARP)
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User Requirements Specification (URS)
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Software Design Specification (SDS)
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Validation Plan (VP)
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Data Integrity Validation Report (DIVR)
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Risk Assessment (RA)
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System Migration Report (SMR)
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Validation Summary Report (VSR)
recommended approach for customers:
Start with basic. Let your quality team understand the validation approach, and how the test documents map to the Requirements Traceability Matrix. If the QA team wants take advantage of our pre-executed test documents to reduce validation burden, purchase them once you understand where they fit in to your validation strategy.
test documents:
The following source evidence documents referenced in the Requirements Traceability Matrix are available separately from the basic package as executed Electronic Batch Records and System Configuration Documents to reduce your validation burden.
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Azure Application Role Assignment
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Azure OpenAI Endpoint Validation
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Managed Application Deployment Verification
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Master Platform Integrity Qualification (MPIQ)
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Automatic Session Timeout
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Closed-Loop Continuous Improvement, Document Governance, and Training Enforcement
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Confirm voided data is not lost
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Controlled decommissioning of records
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Machine-Addressable Truth
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PIN set and recovery
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Risk-Based Omission section prevention inclusion test
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Role-Based Access Control, Segregation of Duties, API Security Enforcement, Concurrent Verification
Validation Package
Request the Validation Package
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