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Inspection Risk Scan

See What an FDA Inspector Would Find

Submit your SOP, deviation report, CAPA, or investigation for review. Get a structured risk diagnostic scored across six pharma-specific dimensions — informed by real FDA enforcement patterns.

1

Submit your document

Select the document type and paste the content or key sections you want evaluated.

2

We score it

Your document is evaluated across six regulatory risk dimensions, informed by real FDA enforcement patterns.

3

You get a risk readout

A scored diagnostic with specific findings, inspection-risk signals, and recommended fixes.

How to Use This Intake

What to submit

  • Text excerpts of SOPs or procedures
  • Deviation or investigation summaries
  • CAPA records and effectiveness reviews
  • Stability protocols or summaries
  • A specific 483 observation
  • A focused quality question

What NOT to submit

  • Confidential records you are not authorized to share
  • Patient data or other PII
  • Anything you cannot share outside your organization
  • A request for medical or legal advice

What happens next

  • Controlled intake — nothing is published
  • DSRV evaluates across the six risk dimensions
  • A human-reviewed Inspection Risk Scan is returned within 24–48h
  • You receive an escalation recommendation
  • Human review is required before any regulated decision

What you receive

  • The six risk dimensions scored
  • Evidence gaps a reviewer would flag
  • Reviewer-style questions an investigator might ask
  • An escalation path
  • Decision support — not a regulated decision, not medical or legal advice

Confidentiality: nothing you submit is published. Submissions are reviewed by humans, not auto-decided. The Inspection Risk Scan is decision support — not medical advice, not legal advice, and not a replacement for the responsible quality unit.

What We Evaluate

Regulatory Defensibility

Would this satisfy an FDA investigator?

Decision Logic Clarity

Can a reviewer follow how conclusions were reached?

Failure-Path Coverage

Are failure scenarios and edge cases addressed?

Escalation & CAPA Triggers

Are escalation criteria clear and defensible?

Documentation Adequacy

Is the record complete enough to stand alone?

Inspection-Risk Signals

Does this match patterns that attract FDA attention?

Each dimension is scored 1–10. Higher scores indicate greater inspection risk. Findings are tied to specific regulatory criteria — not generic document feedback.

Secure handling

Submissions are used to evaluate your request and prepare a response. DSRV does not use customer uploads to train public models. Human review is available, NDA review can be arranged, and retention and deletion expectations can be confirmed before deeper analysis begins.

Select the document type so we can apply the right regulatory criteria and enforcement patterns.

Your risk scan results will be sent to this address.

Paste the document text, key sections, or a detailed summary. Include root cause conclusions, acceptance criteria, escalation decisions, and any regulatory references. The more content you provide, the more specific the risk findings.

0/5,000

Your document is evaluated for regulatory defensibility — not formatting or readability. Results include specific findings, enforcement context, and recommended fixes.

Your document content is never stored beyond the review period or used for training. Confidential.

Not ready to submit a document? Explore what DSRV covers.

Read enforcement intelligenceLearn about Response Strategy Memos