Stability and batch documentation, prepared on site
| Lot | Test | 6 months | 12 months | Page |
|---|---|---|---|---|
| Lot A-0412 | Assay | 99.1% | 98.6% | p. 4 |
| Lot A-0413 | Assay | 99.0% | Not tested | p. 4 |
| Lot A-0414 | Impurity B | 0.08% | 0.11% | p. 9 |
- CHALLENGE
Quality teams rebuilt stability summaries and comparison tables by hand from protocols, exports and batch records.
- WHAT WE BUILT
Matrix connected to approved protocols and study exports, preparing comparison tables and report drafts with every value linked to its source.
- RESULTS5 days → 1 hourTo prepare a stability summary100%Of values linked to their source page0Unpublished data sent outside the organization
