Annual Product Quality Review demo
The whole product year on one screen: 24 attributes trended across every batch, each trend call with its test and the batches behind it, and the APR/PQR written with a citation behind every number. 1:14
What the demo shows
A GMP APR/PQR solution for quality teams that builds each product's annual review with sources.
The morning after a product's review period closes, four collectors pull the year from ERP, MES, LIMS, the QMS and the regulatory system. The trend and capability analyst draws the year as small multiples (24 attributes, from release tests to complaint rates and stability) and makes a call on each (stable, shift, out of trend, cluster, improving) with the statistical test and the batches behind it. The reconciliation checker counts every number in two systems, and the review writer fills the 14-chapter APR/PQR. The product quality lead agrees with or challenges each call, decides the findings and signs; the QP and Head of Quality sign after.
Transcript
- Annual Product Quality Review builds each product's APR and PQR for pharma quality teams.
- By hand, pulling one product's year together takes one to three months.
- Corvina 20mg year has closed.
- 186 batches load and 24 sparklines draw, one per attribute.
- Dissolution is flagged as a trend.
- A downward shift from February, capability 1.08 against 1.33.
- Each call shows its test and its batches.
- The first low batch is the first made with the new cellulose.
- The contract-made tablets on the original cellulose show no shift.
- Priya opens the finding in Chapter 4 and raises the corrective action.
- Drafted the morning after the period closes With every number cited Built on Botminds Agents, data, screens And governance on one platform
Transcribed from the film’s narration. Captions are on the player.