Generate APQRs from evidence, not copy-paste.
Coreworks helps pharma quality teams compile APQR reports from batch records, deviations, CAPAs, complaints, stability, QC, change controls, and other source evidence — with traceable narratives and human approval.
APQRs are too important to be built by chasing spreadsheets.
APQR preparation often means pulling data from quality systems, lab systems, batch records, complaints, CAPAs, stability studies, and spreadsheets — then manually writing the narrative, building charts, and checking evidence.
Coreworks helps QA teams create review-ready APQR drafts where every trend, table, and conclusion links back to source evidence.
What Coreworks builds
APQR / PQR reports
Generate structured annual product quality review drafts using your format.
Trend sections
Create batch, QC, deviation, CAPA, complaint, OOS/OOT, stability, and change-control trend summaries.
Evidence appendices
Attach source-linked evidence for charts, tables, exceptions, and recommendations.
Review-ready narratives
Draft quality conclusions, recurring themes, CAPA effectiveness summaries, and recommended actions.
From quality records to review-ready APQR
- 01Select product, site, and review period.
- 02Coreworks pulls source data and controlled exports.
- 03Agents build trend tables, charts, and narrative sections.
- 04Missing or inconsistent evidence is flagged.
- 05QA reviews every section with source links.
- 06Final report and evidence appendix export for approval and retention.
Works across your source systems
Example prompts
- “Build the 2026 APQR for Product X from batch, QC, deviation, CAPA, complaint, and stability data.”
- “Identify recurring deviation themes and draft the CAPA effectiveness section.”
- “Show all OOT trends and explain whether specification or process changes are recommended.”
- “Create an inspection-ready evidence appendix for this APQR.”
- “Compare this year's APQR to last year and identify recurring risks.”
AI drafts. Quality approves. Every claim is traceable.
Coreworks is designed for quality workflows where human review, source traceability, versioning, auditability, and evidence control matter.
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