Ludus Ready Training · Episode 05

Using Dry Run

Press play — with sound

Training · Episode 05

Using Dry Run

Document in, findings out. The last read is still yours.

Step one

Get the document in

Paste from the QMS

Upload PDF or DOCX

Photograph a page

STB-RPT-2024-041 · Rev 1

text layer · what the review actually reads

Step two

The type picks the pack

Step three

Five checks, five separate answers

01 Conclusions supported by data FLAG

02 Independent review FLAG

03 Version control & effective date NO FINDING

04 Internal consistency FLAG

05 Contemporaneous records REVIEW

Step four

Every finding lands on words in the document

Document · section 3

Table 1 presents results through the 12-month interval. Assay declined from 100.8 to 97.4 percent of label claim. No out-of-specification (OOS) results were observed at any interval.

FLAGInternal consistency

Figure 1 plots assay near 94.7 percent at 18 months, under the 95.0 percent lower limit. Table 1 stops at 12 months, so the text reads clean.

Source · EU GMP Ch. 4 §4.3

Step five

Not enough to tell is an answer

FLAG

01 Conclusions vs data

02 Independent review

04 Internal consistency

REVIEW

05 Contemporaneous records

stays open

NO FINDING

03 Version control

The summary line

Counts, not a grade

Document type: Report (auto-detected)

0123

flags

to review

no finding

there is no bar to fill

In Dry Run

This is the work list

Ref Verdict Criterion and evidence Owner Due

05 REVIEW Contemporaneous records — the 18- and 24-month results appear only in Figure 1, so there is not enough here to tell when they were recorded.

your columns, not ours

Per criterion only. No score, no grade, nothing that clears a document.

Read the guide Open criteria See the demo

1 / 8

Reduced-motion is on, so the episode won't auto-play — use the arrows to step through.

Hit play with sound. Narration is AI-generated. The walkthrough follows the live sample review in the demo; the handoff step follows Export / QMS handoff map. · All Training