JW Pharmaceutical: Turning scattered quality data into a Product Quality Review
Reproducing the work of a QA specialist, from finding source data to preparing a structured PQR document.
The work behind the project.
For JW Pharmaceutical, preparing a Product Quality Review (PQR) meant bringing together information from business systems, quality records, spreadsheets, and laboratory documents. Coxwave worked on automating that process by reproducing how the QA team actually prepared the document.
The information needed for a single review lived across SAP, ERP, EQMS, individual Excel files, and experimental records. Finding a value was only the first step. The author also had to understand its context and place it in the right section.
Some sections followed a fixed structure. Others depended on the specialist’s interpretation and writing practices. A useful solution needed to reproduce both, with verification appropriate to quality documentation.
From knowledge to execution.
Documented work procedures and question-and-answer sessions with the QA team established how the work should be done. The target document became a reusable template, while the team’s explanations informed how information was selected, interpreted, and written.
- 01
Find and extract the source information
The workflow brings together relevant information from enterprise systems, quality records, spreadsheets, and laboratory documents.
- 02
Map evidence into the document
The required PQR structure is converted into a template. Extracted information is mapped to the appropriate fields and sections.
- 03
Reproduce the specialist’s writing
Qualitative sections follow the approach explained by the QA team, extending the work beyond copying values into a form.
- 04
Apply verification policies
Control Plane provides verification and evaluation policies for work that requires high accuracy. Document preparation and the checks around it are treated as parts of the same process.
Clear boundaries. Informed decisions.
The project applies multiple verification and evaluation policies through Control Plane to support the high accuracy required for quality documentation.
Project scope and outcome.
The project brought source discovery, extraction, templating, and document writing into one automation effort. The emphasis was on reproducing the QA team’s process while applying checks suited to the accuracy the work requires.
