Panorama TMF QC - 128 Step Virtual Inspector
128 Step Virtual Inspector Workflow

Panorama TMF QC

A TMF-only Virtual Inspector that works through a 128 step workflow to assess structure, control, traceability, completeness, inspection readiness, and ALCOA+ supporting evidence quality.

Everyone can promise labor savings. Panorama TMF QC is built to save time. Instead of adding more reviewers, it compresses weeks of manual TMF QC into an evidence-driven inspection workflow that moves at machine speed and still produces human-reviewable outputs.

128 step inspection logic

Structured coverage across foundation, protocol control, approvals, subject traceability, safety, monitoring, CAPA, closeout, and final readiness.

Every record gets touched

Baseline enumeration and QC create the coverage layer before deep branch review begins.

Automated, rules-driven inspection

Panorama executes a structured inspection workflow with explicit rules, thresholds, dependency checks, and branch logic before bounded AI is used for interpretation.

Human reviewable results

Coverage ledger, findings, branch decisions, reconstructability assessment, and ALCOA+ supporting inspection-ready outputs are produced for review and signoff.

Built on the FAROUT workflow engine - commercialized as Panorama TMF QC

Not Another Cheaper Review. A Faster One.

Traditional TMF QC saves money only by swapping expensive experts for cheaper labor. That does not solve the calendar problem. Panorama TMF QC is designed to reduce elapsed time by running a structured virtual inspection workflow across the TMF, then handing your team a defensible result set instead of a pile of manual effort.

What slows teams down

Manual review does not scale

Human reviewers open records one by one, reconcile metadata by hand, chase version drift, and build conclusions in fragments. The larger the TMF, the slower the outcome. Cost may move. Time usually does not.

What Panorama changes

Panorama compresses the path to an answer

The Virtual Inspector works through a fixed inspection workflow, persists evidence and decisions, and turns TMF review into a repeatable process with structured outputs. The point is not just lower cost. The point is getting to inspection-relevant answers faster.

This is about saving calendar time, not just reviewer hours.

What the 128 Steps Cover

The L21 workflow spans the major control and execution domains that determine whether a TMF is coherent, traceable, and defensible for inspection support.

1

Foundation

Establish TMF structure, filing model, category inventory, core-category coverage, status-model usability, and category-level completeness signals.

2

Trial Design Control

Resolve the controlling protocol, amendment chronology, impact areas, and downstream recheck obligations.

3

Approvals and Consent

Build approval matrices, consent inventories, and alignment checks across protocol, amendments, approvals, and participant-facing documents.

4

Site Readiness

Review startup, activation, PI qualification, delegation, and training evidence for selected sites.

5

Subject Management

Build subject-flow logic and inspect consent, timing, and eligibility coherence for selected subjects.

6

Safety Documentation

Assess Investigator Brochure control, safety-event documentation, and downstream impacts on approvals and consent.

7

Monitoring, Deviations, CAPA

Evaluate oversight coverage, issue traceability, deviation capture, recurrence, CAPA linkage, and effectiveness signals.

8

Closeout and Readiness

Check unresolved gaps, assess reconstructability, and produce the final inspection-readiness conclusion.

It is not one clever prompt. It is a full virtual inspection workflow.

How Panorama Virtual Inspector Works

Panorama follows a disciplined review model that starts with full-record coverage and ends with a reviewer-ready, ALCOA+ supporting inspection pack.

A

Enumerate every record

Panorama creates a record universe, runs baseline QC, captures metadata, extraction state, and audit-related signals, and ensures every record is represented in the ledger.

B

Establish the control model

The workflow determines the controlling filing model, protocol, amendments, approvals, and consent relationships before deeper operational checks begin.

C

Trace execution and oversight

Panorama follows the filed evidence through sites, subjects, safety, monitoring, deviations, and CAPA to identify where control is coherent and where it breaks.

D

Produce the inspection pack

Outputs include the coverage ledger, findings, branch decisions, reconstructability assessment, inspection-readiness conclusion, ALCOA+ supporting evidence bundle, and reviewer-ready documentation.

Inspection Time Compression Estimator

Labor savings matter. Calendar savings matter more. Use the estimator below to compare manual review time with Panorama TMF QC processing time.

Inputs
Panorama review mode

Results
The point is simple: you can always save money by changing labor. Panorama TMF QC is designed to move the finish line closer.

Why Panorama Feels Different

Panorama TMF QC is not positioned as a generic AI summarizer. It is structured as a Virtual Inspector with workflow state, deterministic checks, bounded interpretation, and reviewer-ready deliverables.

Every record is represented

The workflow begins with baseline coverage so deep review sits on top of a complete inspection substrate, not a selective sample.

Evidence-bounded conclusions

Panorama is built around TMF-filed evidence, persisted artifacts, explicit findings, and ALCOA+ supporting outputs rather than soft narrative alone.

Human signoff still matters

The end state is not blind automation. It is a faster path to a defensible review package your experts can evaluate and approve.

Rules-driven inspection engine

Panorama follows explicit workflow logic, traceable outputs, and bounded AI support to deliver consistent inspection results without turning the process into a black box.

Built for reconstructability

Panorama does not stop at finding isolated issues. It works toward the bigger question: can this TMF be reconstructed and defended?

Built to save calendar time

That is the commercial point. Not just fewer reviewer hours. Faster answers, faster remediation focus, and faster inspection preparation.

See What a 128 Step Virtual Inspector Finds in Your TMF

Panorama TMF QC gives sponsors and clinical teams a way to move from slow, manual QC toward a structured virtual inspection workflow that is built for time compression, not just cost compression.

Private processing. TMF-only evidence discipline. Human-reviewable, ALCOA+ supporting outputs. FAROUT inside, Panorama TMF QC outside.