AI that reads your batch records, drafts your CAPAs, and never signs one on its own.

AI that ingests scanned paper batch records — MBR, BMR, DHR — extracts every entry, signature and result, and rebuilds them as validated electronic records with full audit trail.

One AI intake for every inbound document: purchase orders, sales orders, Certificates of Analysis, invoices, packing lists. Extracts, matches and posts — no manual re-keying.

Ask V5 is a tenant-scoped assistant that answers questions across your batches, deviations, CAPAs, SOPs and supplier records — with citations to the underlying record.

AI drafts your CAPA and deviation narratives from the source evidence — 5-Why, fishbone, risk statement — leaving the investigator to verify, not to type.

AI APR / PQR software. Assembles annual product review from live batch, deviation, complaint, stability and CAPA data — hours, not months.

AI Continued Process Verification. Live SPC across CPPs and CQAs, automatic OOT and trend detection, action alerts — ICH Q10 Stage 3 without the manual monitoring team.

AI-assisted OOS and stability investigations following FDA Phase I/II — instrument, method, analyst and product-quality checks in one guided workflow, drafted from the evidence.

AI monitors FDA, EMA, MHRA, PMDA, TGA, Health Canada and 40+ regulators for guidance, warning letters, recalls and standards updates relevant to your products.

AI supplier scorecards computed from live V5 data — OTIF, CoA accuracy, receiving-inspection rejection, complaint linkage, price variance — with narrative insight, not just a number.

AI detects cost anomalies across BOMs, routings, yield and purchase price — flags margin erosion before the month-end close, with drill-down to the batch and PO.

AI MRP scenario planning — model demand shifts, supplier disruptions, capacity constraints and shelf-life expiries in one place, with a narrative summary of what to do.

AI formula readiness — checks a new or revised formula for material availability, allergen conflict, regulatory eligibility per market and cost impact before it hits production.

AI label & artwork compliance review — checks proofs against the approved formula, INCI, allergen, warning statements and market requirements before printer signoff.

AI-generated daily operations brief — one page per site covering production, quality, supply, people and risk with linked drill-down. Delivered before shift start.