Does it meet spec, and can you prove it — years later, to a regulator?
A full quality lab and quality-management system inside the ERP: define what to measure, bundle it into inspection checklists, decide when inspections are mandatory, run them with approvals and justified overrides, issue a tamper-evident certificate, score suppliers automatically, block a failed batch from release, and run the regulator's paperwork with an audit trail built for inspections.
Any parameter, its own limits
Control and spec limits, rule detection
What it does
- Any quality parameter defined once — numeric with limits, yes/no, pick-list, date, free text, or a formula computed from other results — with exact decimal maths, because 99.50% versus 99.49% is pass versus fail.
- Inspections triggered automatically: every incoming lot, the first lot from a new supplier, every Nth lot, or a random percentage — scoped by item, supplier, warehouse or attribute — blocking the goods receipt until the inspection passes.
- Tamper-evident Certificates of Analysis: numbered per financial year, watermarked, digitally fingerprinted, with a version chain — reissue only with a stated reason, the old version watermarked Superseded, and a one-click check that re-verifies the whole chain for an auditor.
- A quarantined batch cannot be released while its latest approved inspection shows a critical parameter out of spec — and the refusal names the parameters.
- Suppliers scored automatically into Preferred, Standard, Probation or Blocked from acceptance rate, criticality-weighted compliance and delivery, with month-by-month history.
- Statistics without a stats package: control charts with 3-sigma limits and the standard run rules, process capability and its trend, and an automatic anomaly scan every six hours for supplier degradation, parameter drift and rejection spikes.
Also built in
- Ledger posting of quality costs into the books.
- Inspections at the level of an individual serialised unit.
- Quality gates that block a promotion or a release.
- Coverage-gap, cross-batch and routing-heat-map analytics.
- Asynchronous bulk certificate generation for large shipments.
Electronic signatures on every regulator-visible closure, capturing time, network address and device, following FDA 21 CFR Part 11 and named alongside EU GMP. Sample sizes from the ANSI Z1.4 / ISO 2859-1 tables with severity recommended from the last ten lots. Stability studies scheduled per ICH.
FSSAI and HACCP control points on routing steps, supplier-specific expectations pre-filled per Indian supplier, and DPCO-aware release.
Talk to us about quality.
Bring the hardest thing you have had to prove — the lot that failed, the return nobody could place, the audit that cost you a week. That is the demo.