New · pharmaceutical manufacturing
One oral-solids plant, five systems, two years
Two years of a pharmaceutical plant's records, from process order to QP release, and the answer key to what went wrong there.
ERP
AUFK · AFRU · MATDOC · QALS · QAVE · QMEL
LIMS
samples · tests · injections · audit trail
MES
batch records · in-process checks · rooms
eQMS
deviations · OOS · CAPA · QP register
Event logs
OCEL 2.0 · XES · one case per finished batch
- Rows
- 661,497
- Tables
- 65
- Joins
- 25
- Checks
- 133 of 133
- Order to start12.8 d
- Manufacture2.5 d
- Bulk testing to decision4.9 d
- Wait to pack9.3 d
- Packaging0.3 d
- Packaging record review1.5 d
- To QP certification0.2 d
In the answer key
Assay testing went from 1.3 to 3.5 days while two HPLCs were down
83% of batches made with coarse API went past dissolution stage 1, against 12% with fine
One analyst reintegrated 18.2 chromatograms per 100 tests; the next highest 3.7

