The Inspection Response System
How partners deploy ComplianceWorxs.
You don't explain the system. You generate the record. Two deployment modes — one outcome: a defensible record exists where there wasn't one before.
01 · The Moment That Matters
Your client is in the room. The inspector asks the question.
Your client can produce the batch record or the HACCP plan. They cannot produce the Inspection Response Record behind the decision. When that question is asked, you are not reviewing documentation. You are defending it.
- Your client explains the decision.
- The inspector asks for the record.
- The record does not exist.
- That is where 483 observations are written.
02 · What ComplianceWorxs Generates
The record your client should already have.
Built from their existing documentation. Delivered instantly. Inspection-ready.
- Who made the decision — named, titled, timestamped, authorization chain intact
- What evidence they reviewed — every document and data point, listed explicitly
- What regulatory standard they applied — 21 CFR 211, 820, 117, FSMA, HACCP, ICH, ISO 13485, ISO 14971, as applicable
- Why the conclusion was justified — the authorization logic, not just the signature
- Where the documentation gaps are — stated explicitly, flagged before payment
- Mapped to source evidence — every rationale traceable to the underlying DHF, DMR, CAPA, risk file, or batch record entry
03 · What Happens Without This Record
These are not hypothetical. They are what gets written.
In every case below, the compliance work was done correctly. The 483 was issued because the authorization logic was never captured as a formal record.
Pharma · CAPA Closure
CAPA closed without documented authorization rationale
→ 483 observation under 21 CFR 211.192. Investigator cites failure to demonstrate who determined the corrective action was effective and on what evidence the closure was authorized.
Med Device · Design Control
Design change implemented without documented authorization rationale
→ 483 observation under 21 CFR 820.30(i). Investigator asks who reviewed the change against design inputs, what risk analysis was applied, and on what evidence a new verification was not required.
Pharma · OOS Investigation
OOS conclusion authorized without a retrievable decision record
→ 483 observation under 21 CFR 211.192. If the authorization for invalidation or disposition cannot be produced as a discrete record, the conclusion is treated as undocumented — regardless of what actually happened.
F&B · Finished Product Release
Finished product released with no retrievable decision justification
→ FSMA 21 CFR 117 observation. Investigator asks who determined the lot was safe to release, what evidence they reviewed, and why they concluded the hazard was controlled.
F&B · CCP Deviation
CCP deviation closed with no traceable decision ownership
→ Warning letter risk under FSMA. Deviation dispositioned without acceptance criteria, without documented alternatives considered, without the authorizer's residual risk position captured.
04 · How Partners Deploy
Two modes. One outcome: a defensible record exists.
Active Inspection Risk
$297
Inspection Response Record
- Use when a client is facing an audit or has a specific decision under scrutiny
- Generate the record for the decision in question — same session
- Show the client exactly where they are exposed before the inspector does
- Inspection-ready record on delivery. No fulfillment delay.
Ongoing Clients
$999/mo+
Membership — Inspection Response System
- Use for clients making multiple regulated decisions per month
- Every decision has a defensible record on demand
- Removes reconstruction burden permanently
- Membership becomes the system of record for every authorization
★ Partner Exclusive
The $297 IRR value applies toward membership onboarding.
When your client unlocks an IRR, the $297 credit applies toward their first month of membership within 48 hours. You become the person who identified the gap, generated the record, and removed the problem permanently.
See what you earn.
Commission structure, payment, and the math on a single enterprise client.
See the revenue →