Schedule M 2026, CPCB and IATF compliance — automated, audit-ready, and always inspection-day ready.
The revised Schedule M kicks in for Indian pharma MSMEs in 2026 — and a failed audit can mean a suspended licence and ₹10–50L in exposure, not to mention lost contracts. PARAM-COMPLY replaces the binders, WhatsApp photos and spreadsheet checklists with a single digital system: auto-generated, audit-ready reports; 21 CFR Part 11-aligned electronic records with full audit trails; automated cold-chain logging; digital checklists with evidence capture; and closed-loop NCR/CAPA tracking. It gives you MasterControl-grade documentation discipline at roughly a quarter of the price, deployed by engineers who actually walk your floor.
| Capability | MasterControl | PARAM-COMPLY |
|---|---|---|
| Platform cost | ₹15L + steep annual licences | From ₹3.5L ✓ |
| Schedule M 2026 templates | Generic, US-FDA-centric | India Schedule M-native ✓ |
| 21 CFR Part 11 e-records | Yes | Yes — aligned ✓ |
| NCR/CAPA closed loop | Yes | Yes, included ✓ |
| Cold-chain logging | Third-party add-on | Built in ✓ |
| Implementation & support | Offshore, ticket-based | On-site Indian engineers ✓ |
Book a free compliance audit — our engineers map your gaps against Schedule M, CPCB and IATF, then show you the exact path to inspection-ready.