Part 01 · The Question→Part 02 · The Record→Part 03 · The File
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Inspection Case File · CF05 · Part 03 of 03

Three ways to close the gap. Start with the lowest commitment.

A free template to see the structure. The complete case file when you're ready to produce a defensible record. The full inspection set if this isn't an isolated decision in your facility.

Built around 21 CFR 211.100 · Q9 · Used by Quality and Validation leaders preparing for FDA and EMA inspections
Where this leaves you

You've seen the inspector's question, the gap in the file, the five required fields, and the reference DDR excerpt. The structure is no longer a mystery. The decision now is what to put in your facility's records.

The Complete File

Three escalating levels. Each builds on the last.

If you're not certain this applies to your facility yet, start with the free template. If you are, the complete case file is the next step. If this isn't isolated to one decision, the full inspection set covers all ten scenarios.

Start Here · Step 01 of 03 Free
The Blank DDR Template
The five-field authorization record structure as a blank document. Apply to your facility's data.

What's Included

  • The seven-section blank Decision Defense Record template
  • Field-level guidance on what each section requires
  • 21 CFR 211.192 citation header
  • Print-to-PDF formatted for controlled record use

Not Included at This Level

  • The completed reference DDR (Vancomycin scenario)
  • The evidence checklist (10 items to gather before authorizing)
  • The 483 observation reference language
$0 Email delivery · No card required
Download the Record Structure →
See the Completed Version · Step 02 of 03 Most Common
CF05 · The Complete Case File
The completed reference DDR plus everything you need to build defensible records before your next inspection.

Everything in the free template, plus:

  • The complete reference DDR for Metoprolol Tartrate Tablets 50 mg — Change Control CC-2024-0156 — fully authorized, ready as a model
  • Full alternative-causes evaluation (the field most files don't have)
  • The evidence checklist — 10 items to gather before authorizing any deviation root cause conclusion
  • The exact 483 observation language an investigator drafts when this gap appears
  • Cited regulatory framework: 21 CFR 211.100 · ICH Q9 · ICH Q10 · 21 CFR 211.180(e)
If this does not match what your investigator would expect, request a refund. No questions, no friction.
$149 One-time · Delivered immediately
Unlock the Completed Record — $149
If This Isn't Isolated · Step 03 of 03 Save $1,193
The Full Inspection Set — All 10 Case Files
If your facility has gaps in more than one decision class — batch release, OOS, change control, CAPA, data integrity, and six others — the bundle covers the full inspection surface.

Everything in CF02, plus:

  • CF01 Process Validation Conclusion — when validation reports are signed but the conclusion logic isn't recorded
  • CF02 Deviation Root Cause — when 'operator error' is concluded without documented elimination of systemic causes
  • CF03 OOS Investigation Closure — when laboratory error is concluded without documented elimination of assignable cause
  • CF04 Deviation Risk Assessment — when no-impact is concluded without documented risk evaluation
  • CF06 CAPA Effectiveness — when effectiveness is concluded without documented evidence
  • CF07 Data Integrity Determination — when audit trail anomalies are explained but not documented
  • CF08 Supplier Qualification — when approval rationale cannot be reconstructed
  • CF09 Stability OOT Disposition — when no-impact lacks defensible basis
  • CF10 Complaint Investigation — when no-action determination cannot be defended
$297 All 10 · vs. $1,490 individually
Get the Full Inspection Set →
Why now

FDA inspections occur on a 2-year cycle. Authorization records take longer than that to build well. Building under inspection pressure is not the same as having one in the file when the investigator arrives.

The 483
"Failure to document the scientific and risk-based rationale used to justify the risk categorization of the change, including the specific evidence supporting the determination that revalidation, requalification, or regulatory notification was not required. The change control record establishes that the change was approved but does not reconstruct the reasoning that justified the risk classification."
21 CFR 211.100. The observation that this case file is built to prevent.
Common Questions

What buyers ask before they purchase.

Is this a template I can use immediately?
Yes. Both the free template and the $149 case file include a blank DDR you can complete with your facility's data and produce as a controlled record. The $149 case file adds the completed reference example, evidence checklist, and 483 reference language.
What format is the file?
Web page formatted for print-to-PDF. Document control header, numbered sections, monospace citations — designed to look like a controlled record. Print directly from the browser, save as PDF, attach to your QMS.
Does this replace my QMS deviation workflow?
No. ComplianceWorxs sits above your existing QMS. Your QMS captures the deviation, the investigation, and the CAPA closure. The Decision Defense Record captures the authorization logic behind the root cause conclusion — the part most QMS workflows do not capture, which is the gap an investigator cites.
Is this scenario-specific or general?
CF05 is specific to change control risk determination under 21 CFR 211.100. The reference example is quality systems specific. The five-field structure applies to any change control risk determination in an FDA-regulated facility.
What happens after I purchase?
You receive immediate access to the complete case file. No account required. Delivery is instant via email and direct browser access.
Refund policy?
If the $149 case file does not match what your investigator would expect, request a refund. No questions, no friction. The bundle does not carry a refund — it is priced at 80% off individual pricing as a commitment offer for buyers who recognize the pattern across multiple decision classes.
Free Template · Email Delivery

Send me the blank DDR template.

Email delivery, no card required. The blank seven-section authorization record structure, ready to apply to your facility's data.

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Decision Time

Free template, complete case file, or full inspection set. Pick the level that matches your exposure.

Free Template Case File · $149 Bundle · $297

Used by Quality and Validation leaders preparing for FDA and EMA inspections.
21 CFR 211.100 · ICH Q9 · ICH Q10 · 21 CFR 211.180(e)