1,247 controls. Audit-ready in hours.

Schedule M was revised by the Drugs and Cosmetics (Amendment) Rules, 2023 (gazette notification December 2023, effective onwards). Three big shifts: (1) Control count expanded from ~340 to 1,247; (2) ALCOA+ data integrity became enforceable, not aspirational; (3) Indian Schedule M now closely aligns with USFDA expectations (21 CFR Parts 210/211, Part 11), reducing the gap between Indian and export-bound compliance. All Indian pharma manufacturing units fall under the revised framework with phased enforcement based on plant tier.

Yes. All 1,247 controls in Schedule M revised 2024 are pre-mapped in TrusTwin's framework library. During pilot deployment, our team maps each control to your plant's specific equipment, SOPs, and batch records. The pilot timeline is 8–12 weeks from kickoff to a first generated, inspector-ready Schedule M audit pack. Indian pharma customers running on Wistwin since 2024 have had 6 of 7 audits close with zero NCRs.

ALCOA+ is the data integrity standard underpinning Schedule M (revised 2024) and 21 CFR Part 11. Attributable (who did it), Legible, Contemporaneous (when it happened), Original (or true copy), Accurate, +Complete, +Consistent, +Enduring (durable storage), +Available. Wistwin enforces ALCOA+ by design: every data point captured is signed (user / system / timestamp), versioned (no destructive edits), audit-logged (every change recorded), and durable (immutable storage, India data residency). Paper records become findings · Wistwin replaces them with system-of-record electronic capture.

AssetTwin imports paper batch records via OCR + structured templates during the 4-6 week ingestion phase. The shift forward then runs digital from the supervisor mobile app, while historical paper records are searchable and audit-evidenced. We don't ask you to retroactively digitize 10 years of paper. We make today digital, and audit-link yesterday. CDSCO inspectors are pragmatic about transition periods · they want to see forward-going compliance, not retroactive perfection.

AviraTwin handles continuous environmental monitoring for Schedule M Annex 2 (sterile manufacturing). Particle count (0.5µm and 5.0µm per ISO 14644 cleanroom classification), HVAC parameters (differential pressure between rooms, temperature, relative humidity), microbial monitoring integration (where in-line samplers exist), VOC / solvent vapour monitoring. Continuous trend analysis · clean-room excursions caught before they breach action limits. Annex 2 is the deepest scrutiny domain · and where most pharma audits surface findings.

When the CDSCO inspector arrives, TrusTwin generates a Schedule M audit pack on demand · every control's PASS/DUE/NCR status, evidence linkage, drill-down to source data, CAPA history. The pack exports as PDF for inspector review or structured XML for regulator submission. Our deployment team includes former CDSCO inspectors who know what's looked for and how to present. Wistwin doesn't promise zero findings · we promise the findings will be defendable.

Yes. Indian Schedule M (revised 2024) aligned ALCOA+ data integrity to 21 CFR Part 11 (USFDA Electronic Records and Signatures). Wistwin's ALCOA+ implementation satisfies both. One framework, two regulator audiences. For USFDA-bound export plants (Hyderabad, Vapi, Baddi cluster), one audit prep generates inspector packs for both CDSCO and USFDA assessors. 21 CFR 210 / 211 mappings are pre-loaded; 483 / Warning Letter risk areas are flagged in the dashboard.

Pilot: 8–12 weeks for a single plant + Schedule M framework live with AssetTwin + TrusTwin + AviraTwin (Annex 2 cleanroom). Multi-plant: 4–6 months for hub-and-spoke architecture across plants. Most pharma customers see their first generated Schedule M audit pack within 60 days of pilot kickoff. We typically time pharma deployments to land 3-6 months ahead of an expected CDSCO audit cycle so the audit pack is mature when the inspector arrives.

Yes · we have multiple Indian pharma customers across Hyderabad and Vapi running on Wistwin since 2024 with Schedule M revised 2024 framework live. Reference customer introductions are arranged during the buying process once we have a mutual NDA in place. Customer authorization for public case-study disclosure is in progress for two named customers, expected Q3 2026.

Pricing is not published. Every Wistwin Schedule M deployment is sized to your plant · site count, asset count, module mix, regulatory scope, and integration requirements. Indian pharma customers typically see rapid payback driven by audit-prep compression, consulting fee reduction, and avoided NCRs alone. Talk to our team for a tailored quote.