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The Evidence Platform
Can you keep me inspection ready every day?

Inspection-ready evidence,
continuously assembled.

Every protocol decision, workflow event, reconciliation, signature, query resolution, and approval becomes regulated evidence automatically. Not assembled at the end. Composed as the study runs.

The Inspection Evidence Package combines Clinical Intelligence generated before and during study conduct with operational evidence accumulated throughout execution. Every section is continuously assembled, fully traceable, and inspection-ready from the moment it is created.

  1. 1Protocol Imported
  2. 2Intelligence Generated
  3. 3Execution Started
  4. 4Evidence Added
  5. 5Inspection Ready
  6. 6Submission
Evidence Proof

The regulated document a 21 CFR Part 11 inspection would actually receive.

Inspection readiness is not a document produced at the end of a study. It is the accumulated result of thousands of operational events captured throughout execution.

The Inspection Evidence Package structure shown below is what a real customer's IEP renders inside PrismCDM. 11-section Table of Contents (now leading with Operational Activity), sample section preview, three-role electronic sign-off (Operator, QA, Regulatory) via the §11.50 re-authentication ceremony, five-axis generation footer.

Inspection Evidence Package
Representative · Demo

Representative demonstration. The structure below illustrates how a real customer's Inspection Evidence Package is composed inside PrismCDM. The values shown are representative for demonstration purposes and do not reflect any specific sponsor study managed by PrismCDM.

Representative Study

Phase 3 study · mid-execution draft

Inspection scope
21 CFR Part 11 + ICH GCP
IEP Coverage (representative)
41%Evidence collection in progress · draft and inspection-ready sections shown below
Table of Contents (representative structure)
  1. 1Executive SummaryDraft
  2. 2Study OverviewInspection-ready
  3. 3Protocol IntelligenceInspection-ready
  4. 4Operational ActivityDraft
  5. 5Clinical Data QualityIn Review
  6. 6Amendment HistoryInspection-ready
  7. 7Findings and RecommendationsInspection-ready
  8. 8Provenance IndexInspection-ready
  9. 9Audit TrailInspection-ready
  10. 10Part 11 SignaturesInspection-ready
  11. 11Submission ReadinessLive
4Operational Activity
Draft

Each Inspection Evidence Package combines Clinical Intelligence with operational events accumulated throughout study execution. Every section is continuously assembled, fully traceable, and inspection-ready from the moment it is created.

Section findings (representative)

Findings issued by the Intelligence Engine for this study section, each identified, scored, and traced to the extraction event that produced it.

Section recommendations (representative)

Recommendations connecting findings to operational actions, each cited back to the findings that supported it and carrying priority + expected impact.

Inspection Sign-off Required
OperatorQARegulatory

The three signature roles above are configured per the customer's sign-off policy and captured via the 21 CFR Part 11 §11.50 re-authentication ceremony. Each signature is linked to the evidence hash per §11.200.

Signatures collected upon IEP coverage reaching 100% and all sections marked Inspection-ready.

Generated
Date
2026-07-15
Engine
Clinical Intelligence Engine v1.2
IEP Schema
IEP Schema v2.1
Corpus Snapshot
Public Registry Snapshot 2026-07
Build
v1.6.3

Representative demonstration. The values shown are illustrative of the IEP structure PrismCDM composes for customer studies. No specific sponsor study is depicted here.

Evidence is created

as work happens.

Not reconstructed when an inspection is scheduled.

Early Access

See how operational events become inspection-ready evidence.

The clearest way to evaluate continuous evidence generation is to put one of your protocols through the platform and walk the resulting Inspection Evidence Package section by section.