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The Record Behind the Decision / Unit 1
Lesson 2 · Evidence · Week 2
What would establish performance?
What evidence would establish that the required check occurred, and what would you decide while it is still missing?
Start with the question
A verification line is blank. New evidence arrives that is consistent with the check having happened, and none that records it. What would establish performance, and what would you decide while it is still missing?
By the end of this lesson you should be able to:
- State what an evidence packet establishes and what it does not.
- Tell an independent record from a recollection or from presence.
- Qualify a conclusion while evidence is incomplete, and name what must stay open.
- Explain what an authorizing person can and cannot authorize on an unestablished check.
Read
Read the article this lesson is built on (about 7 minutes): What Establishes That the Check Happened?
Watch
Transcript
Last lesson, a blank verification line told you about the record. It did not tell you whether the check happened.
This lesson puts you inside a synthetic case. You will make three decisions. New evidence arrives after the first.
Start with the first packet. The operator dispensed an excipient and initialed the step. The line for the second person is blank. The supervisor says the operator did the work correctly, and proposes retraining.
Before you answer, separate three things. What does the packet establish? What does it not establish? And what would you need to see next?
Then the second packet arrives. A balance printout shows the weight and the lot. A badge log places a colleague, KP, in the room. The operator recalls KP looking at the label.
Notice what each item can carry. A printout and a badge log are records, of a weighing and of presence. Neither records the check. A recollection, taken by the supervisor who proposed closing the item, is not independent. Being present is consistent with a check. It is not a record of one.
So the question changes. It is no longer only what happened. It is what the record can support, and what must stay open.
The third decision is the authorizing person's. Who can authorize what, on which conclusion, while the check is still not established?
Make each judgment before you read ours. Then compare your reasoning with the worked explanation, including what remains uncertain.
Work the case
This is a synthetic case. It uses no real batch, product or person. You will examine evidence, make a judgment, receive more evidence, and reconsider. The first judgment is free; the rest of the case is part of the Season One pass. We record usage events (which option was chosen and whether the case was completed) for analytics; no free text is collected.
Read the case without the exercise
The Missing Verification Entry
A batch record for a solid oral dosage form requires an independent verification of the material identification before dispensing. At step 14, an operator dispenses an excipient lot and initials the entry. The line for the second person who verifies the material identification is blank.
During in-process batch record review at the end of the shift, before the dispensed material is charged to the next process step, Quality finds the blank line. The supervisor, who proposed the closure, recommends treating it as a documentation error and retraining the operator on good documentation practices.
In US CGMP, 21 CFR 211.101(c)–(d) calls for a second person to examine each container of component dispensed (including that the containers are properly identified) and to verify each component added, and 21 CFR 211.188(b)(11) requires the record to identify the person checking each significant step. 21 CFR 211.192 addresses the investigation of unexplained discrepancies.
Initial evidence packet
- Batch record, step 14: "Dispense microcrystalline cellulose, lot ML-4471, 62.5 kg. Verify material identification against the lot label before dispensing." Dispensed by: operator JR, initialed 08:44. Independent verification by: [blank].
- Batch record, step 13 (balance check): verified by KP, initialed 08:31.
- Supervisor note: "The operator did the work correctly. Verification line missed. Retrain on GDP and close."
Establishes: The operator completed step 14 and initialed it at 08:44. The verification line is blank.
Does not establish: Whether any second person verified the material identification, and whether the lot dispensed was the lot named.
The additional evidence, the two further judgments, the comparison of interpretations and the worked explanation are part of the Season One pass.
Written with AI under ComplianceWorxs governance. Checked by a separate AI reviewer against the cited sections of 21 CFR Part 211 on November 7, 2026. No human GMP expert has reviewed or signed off this content; it is not a regulatory determination.
How access and saved progress work
- After a unit is released
- It stays open to you. Work through it at your own pace, in any order within the units released so far.
- Your access period
- 12 months from the day you enroll, for one person.
- Saved progress
- Your place in each case exercise is saved to your pass. Open your access link on any device to continue where you left off. Without a pass, progress is saved only in that one browser.
If a decision like this is open for you
These already exist on this site. You do not need them to continue the lessons.
See a complete worked decision laid out as evidence, judgment, risk and authorization.
Free← Was the work performed?Unit 2 opens on November 30