COMPLIANCEWORXS The Record Behind the Decision

INSPECTION RESPONSE RECORD

Inspection Response Record — generated after assessment

Secure Session

Reconstruction in Progress

INSPECTION RESPONSE RECORD · $497

Get an inspection-ready Authorization Record — start with a free assessment.

The Inspection Response Record ($497) is the finished, inspection-ready record ComplianceWorxs produces once your authorization has been assessed. The assessment itself is free: upload your documents or enter the decision manually, and we tell you what's missing before you pay anything.

Start Your Free Assessment → No payment, and no card, at this stage.

Reconstruct the decision as it existed at the time. Do not strengthen the reasoning with hindsight.

Everything after Section 4 is produced independently from the record you submit.

Every Inspection Response Record is built around an Authorization Record — the missing record that captures the reasoning behind the decision.

RECORD ID

— not yet issued —

REVISION

1.0

STATUS

DRAFT

DECISION TYPE

Not selected

DATE OF RECORD

30 July 2026

PREPARED BY

—

BEFORE WE BEGIN

  • Authorization type
  • Investigator’s question
  • Decision made
  • Basis for authorization
  • One evidence reference

Everything else improves the assessment but is optional.

START HERE

UPLOAD YOUR AUTHORIZATION PACKAGE

Upload the record as it stands. We read it, reconstruct the authorization, and assess whether it holds against the standard an FDA investigator applies — you do not need to retype anything.

1

Drop your documents here

or

  • Up to 10 files
  • Up to 30 total pages
  • PDF, Word, or Excel
  • Maximum 25 MB per file

    CAPA records · investigations · root cause analyses · SOPs · effectiveness reviews · validation · risk assessments · training records · deviations · change control · supporting evidence

    2

    We send the assessment link here, so you can close this page.

    Upload securely. Know what the record supports. Keep control of the decision.

    • TLS-encrypted in transit & at rest
    • Assessed via Anthropic’s Claude — never used to train AI models
    • SOC 2-grade infrastructure

    Private to your assessment link only. ComplianceWorxs evaluates whether the record supports the conclusion — it does not make the decision or replace your approval authority.

    Documents are encrypted in transit and at rest, and kept only as long as your assessment needs them.

    Don’t have your documentation?

    Across the organization

    The IRR creates the Record Behind one important decision. The Decision Record Workspace shows Quality leadership the status of every important decision, open record, commitment, owner, and recurring gap.

    One record answers one question well. The Workspace answers the ones that come after it: what needs attention now, who owns the next action, what is overdue, and whether the same problems keep happening across sites, functions and decision types.

    See how IRRs are managed in the Workspace →