Reviewer & Director Sign-Off
Two-step approval, immutable lock, PDF validation packet.
Studies move from draft to reviewer approval to director approval and lock. An on-screen approval timeline records who approved, when, and with what notes. Locking prevents edits, and the downloadable packet carries the full evidence. Corrections after lock follow a documented path.
Capabilities
What you can do
Approval timeline
Every state and approver is visible on the study.
Lock & immutability
Locked studies cannot be changed—corrections are new, documented work.
Validation packet
PDF with datapoints, calculations, outcome, and signatures.
Audit trail
Approvals and changes recorded for inspectors.
Connected features
Works hand in hand with
Inspection Rounds
Checklists for CLIA, CAP, and internal audits—with linked evidence.
- Checklist rounds
- Linked evidence
- Findings to CAPA
Assay Go-Live & Patient Reports
A controlled path from validated to live—and patient-ready PDFs after.
- Submit → Approve → Live
- Validation summary
- Patient report PDF
See Reviewer & Director Sign-Off in action.
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