Decision Documentation Assessment
Find where the record becomes hard to explain.
Use one completed deviation or investigation to identify what the existing record preserves—and what may need to be reconstructed.
Start the 3-minute assessment →
The Record Behind the Decision
Inspection ReadinessStarts with the Record.
When the decision is questioned, the record should show what was known, what was weighed, and why it was authorized.
Start with the decision in front of you.
Start with the decision you need to defend.
Find where the record becomes difficult to explain, create the reasoning record behind it, inspect a completed example, or see the questions investigators ask.
Inspection Response Record
Preserve the reasoning behind the decision.
Create the reviewer-ready record of the evidence, judgment, alternatives, risk, conditions, and authorization behind one consequential GMP decision.
Create an IRR — $497 →Completed Record
See exactly what gets preserved.
Inspect a completed example showing authorization, evidence, risk and limitations, decision reasoning, and audit history.
See the completed sample →Click any row. See the question an inspector asks and the answer the record gives.
Evidence that matters
Links the decision to the specific records and results reviewed.
Sound judgment
Shows how the evidence was weighed and which alternatives were rejected.
INSPECTION RESPONSE RECORD
IRR-2026-0487DecisionRelease batch B-24019 with continued monitoring. This decision covers batch B-24019 only.
Inspector asksWhat did you rely on?
The record answers
- Batch record B-24019
- Release test results
- CAPA effectiveness review
Each item is cited by record, so the reviewer can open exactly what the decision rested on.
Inspector asksHow did you weigh the evidence, and what else did you consider?
The record answers
- Hold the batch pending more stability data. Rejected. Acceptance criteria were met and the open question is long-term, not release-critical.
- Release with no follow-up. Rejected. Long-term stability data is limited, so monitoring is a condition of release.
Inspector asksWhat didn't you know when you decided?
The record answers
- Risk weighed. Short-term data is within specification. Long-term behavior is not yet established. Residual risk accepted on condition of monitoring.
- Follow-up. Monitoring plan, owner, and review date are recorded with the decision.
Inspector asksWho authorized this, and when?
The record answers
- Decision owner. Dr. Sarah Chen, Head of Quality.
- Timestamp. Captured at the moment of authorization, before release. Recorded, not reconstructed.
Illustrative sample. Names, batch, and record number are fictional.
See the record behind the decisionFictional example · Opens the full record
Transparent limitations
Records known uncertainties and follow-up actions.
Accountable authorization
Names the decision owner with date and time.