Browse. Select. Buy. Every product is an inspection-ready authorization record built for the compliance professional who already knows what the investigator is going to ask. No consultation. No demo. Instant access on purchase.
Products from $27 — $875
Complete Package Best Value · All 10 Files
Complete Authorization Package — 10 Case Files
All 10 Inspection
Case Files.
Case Files.
10 scenarios · 10 authorization records · Complete 21 CFR coverage
Includes
- Process Validation Authorization Record
- Batch Release Exception Authorization
- OOS Investigation Decision Record
- Deviation Root Cause Authorization
- CAPA Effectiveness Closure Record
- Change Control Risk Authorization
- Data Integrity Audit Trail Record
- Supplier Qualification Exception Record
- Stability OOT Determination Record
- Complaint Investigation Disposition Record
$875 $1,490 Save 41%
Get All 10 Case Files → Authorization Bundle 3 Files · Most Common Inspection Scenarios
Authorization Bundle — 3 Case Files
Deviation, CAPA &
Batch Release.
Batch Release.
3 scenarios · 3 authorization records · 21 CFR 211 & 820
Includes
- Deviation Root Cause Authorization Record
- CAPA Effectiveness Closure Record
- Batch Release Exception Authorization
$297 $447 Save 34%
Get the 3-File Bundle → CAPA & Deviations 2 products
CF-04
04
Inspection Case File 21 CFR 211.192
Deviation Management Deviation Root Cause Authorization Record
The authorization record that captures who evaluated the deviation risk, what impact assessment was conducted, and who formally closed it.
$149 Instant access
Buy → CF-06
06
Inspection Case File 21 CFR 820.100
CAPA Effectiveness CAPA Effectiveness Closure Record
The authorization record that proves who determined the CAPA was effective, on what evidence basis, and when the closure was formally authorized.
$149 Instant access
Buy → Batch Release & Stability 2 products
CF-02
02
Inspection Case File 21 CFR 211.192
Batch Release Batch Release Exception Authorization
The authorization record that shows who reviewed the batch exception, what evidence was considered, and why release was approved.
$149 Instant access
Buy → CF-09
09
Inspection Case File 21 CFR 211.166 · ICH Q1E
Stability OOT Stability Out-of-Trend Determination Record
The decision record that captures who authorized the OOT determination, what trending criteria were applied, and why further action was or was not required.
$149 Instant access
Buy → Laboratory Investigations 2 products
CF-03
03
Inspection Case File FDA OOS Guidance 2006
OOS Investigation OOS Investigation Decision Record
The decision record that shows who authorized the OOS conclusion, what data triggered the investigation, and why the result disposition was justified.
$149 Instant access
Buy → CF-07
07
Inspection Case File FDA Data Integrity · EU Annex 11
Data Integrity Data Integrity Audit Trail Record
The inspection record built for the audit trail review — who conducted it, what anomalies were evaluated, and who authorized the data integrity conclusion.
$149 Instant access
Buy → Validation & Change Control 2 products
CF-01
01
Inspection Case File GAMP 5 · 21 CFR 211.68
Process Validation Process Validation Conclusion Record
The inspection record for who authorized the validation protocol execution and what evidence confirmed the process met its predetermined acceptance criteria.
$149 Instant access
Buy → CF-05
05
Inspection Case File 21 CFR 820.70 · EU Annex 11
Change Control Change Control Risk Authorization Record
The inspection record that shows who authorized the regulatory impact assessment and what evidence supported the change classification decision.
$149 Instant access
Buy → Supplier & Complaints 2 products
CF-08
08
Inspection Case File 21 CFR 820.50 · EU GMP Ch. 7
Supplier Qualification Supplier Qualification Exception Record
The authorization record that shows who approved the supplier, what quality evidence was reviewed, and what risk level was formally assigned.
$149 Instant access
Buy → CF-10
10
Inspection Case File 21 CFR 820.198 · MDR
Complaint Investigation Complaint Investigation Disposition Record
The authorization record that shows who concluded the complaint investigation, what product impact was assessed, and whether reportability was formally authorized.
$149 Instant access
Buy → Coming Soon Lower-priced additions
DAM-01
DAM
Decision Governance 21 CFR 211 & 820
Decision Governance Decision Authority Matrix
A decision governance control map across 6 regulatory sections — Deviations, CAPA, Batch Release, Change Control, Validation, and Governance — identifying every decision that requires a formal authorization record, who must authorize it, what evidence is required, and what the inspection failure condition is.
$27 Instant access
Buy → CL-01
CL
Pre-Inspection Checklist Authorization Gap Audit
Pre-Inspection
Authorization Gap Audit Checklist
Structured checklist for identifying which decisions in your quality system lack a formal authorization record before the investigator asks.
$37 Coming soon
Coming Soon GD-01
GD
Response Guide 483 Response Framework
483 Response
483 Authorization Observation Response Guide
The response framework for organizations that received a 483 observation related to decision documentation — what to show, what to build, how to close it.
$97 Coming soon
Coming Soon