Zometric Continuous Process Verification & APQR Reviews & Product Details

Zometric Continuous Process Verification & APQR is built for regulated pharmaceutical manufacturing, automating the two most resource-intensive compliance activities in the plant. The Annual Product Quality Review stops being a months-long sprint and becomes a living document the inspector can open today. Compliance becomes the byproduct of doing the work, not a separate deliverable. What changes versus the traditional APQR process: * Data collection: manual consolidation from paper and spreadsheets, arriving months after the campaign, is replaced by automated real-time streaming from instruments, MES and Zometric Edge. The data is in the dashboard before the batch is released * Analysis: offline statistical studies with limited visibility are replaced by live control charts and capability statistics. CPV becomes a state you observe, not a study you run once a quarter * Reporting: the static, hard-to-verify annual PDF becomes a dynamic living document that updates as the process runs, always traceable to the underlying records * Storage: high-cost paper archives kept for years are replaced by searchable digital storage. Retrieval that took weeks now takes seconds, with full lineage to the source measurement Compliance architecture: * 21 CFR Part 11 electronic signatures on every action * Complete user-action audit trail per record * Anytime inspection readiness: when the inspector arrives, you do not prepare, you open the dashboard. Every record, every signature, every trend is one click away Built for the standards your regulators already require: US FDA 21 CFR Part 11, ICH Q10, US FDA cGMP, ISO 13485 and 21 CFR 820, extending coverage to medical device quality systems. Analysis runs on the same validated Statistical AI engine behind the Zometric platform, including ICH Q1E compliant stability studies. Deployed at pharmaceutical manufacturers including Brawn Laboratories, Extrovis and Sekhmet Pharmaventures group companies. Browser-based, deployable cloud, hybrid or on-premise. Free pilot configurable in 2 to 3 weeks with your real data.