Sector 02 of 06 · Pharma

Schedule M 2024 ready, every batch.

Audit-ready, not just digital.

GMP pharma plants under the revised Schedule M 2024 documentation rules. Contractor induction trail tied to every gate event. BRSR-ready training records for the workforce disclosure. Hazard-zone access enforcement at MAH units. Zentry produces the cleanroom-grade evidence chain Schedule M assessors now demand.

SCHEDULE M · BATCH 14GMP audit
100%
CONTRACTORS INDUCTED · BATCH 14
✓ 124 · all certified
✓ Current for batch
✓ 18 entries signed
2 workers · within 7 days
EXPORT SCHEDULE M PACK
Schedule M 2024 · CDSCO-ready
Audit cadenceSchedule M 2024 surveillance · customer audits
Key buyersEHS Head, Compliance Head, Plant Head
Compliance hooksSchedule M 2024, MSIHC, §41B, IS 14489
RecommendedSitewide+ bundle, Hybrid Edge
Why Pharma chooses Zentry

Schedule M 2024 ready, every batch.

Schedule M revised 2024 changed the bar for pharma GMP plants in India. The induction trail is no longer optional. Every contractor on the cleanroom floor must have a current, documented, signed induction certificate tied to a verifiable gate event. The CDSCO assessor wants to see the chain: gate-in, induction-current, training-current, zone-authorised, exit. Paper sign-off sheets in the EHS cabin no longer pass.

Zentry builds that chain end-to-end. Pass captures every entry to the plant. Induct enforces the 3-minute kiosk induction with on-screen exam and signed certificate. Learn maintains the role-based training records the auditor cross-references. Gate verifies certificate validity at every cleanroom door. The whole stack is air-gappable for data-sovereignty-sensitive plants and meets the BRSR workforce disclosure for listed manufacturers.

What the Schedule M assessor sees:

  • Per-batch contractor induction trail, every worker tied to a signed certificate.
  • Per-zone access logs, every cleanroom entry tied to a current training record.
  • Hazard-zone disclosure log for MAH units, signed by every entrant.
  • BRSR workforce training disclosure exported in the filing-ready pack.
  • Visitor log including all prior audit visits and external GMP assessors.

From a paper sign-off sheet to a gate-anchored, signed, auditable chain.

The wedge

The modules Pharma plants start with.

The 2 to 3 Zentry modules that open the conversation in your sector. Most Pharma plants begin here, expand later.

Compliance hooks

Statutes that drive Pharma buying decisions.

Schedule M 2024

Pharma GMP contractor induction trail. Per-batch, per-contractor, per-zone evidence chain for the revised 2024 GMP audit.

MSIHC 1989

Chemical contractor hazard-zone induction with signed acknowledgment for pharma plants with MAH classification.

Factories Act §41B

MAH-unit contractor and visitor induction trail. Inspector-ready exports per period.

IS 14489 (OSH Audit Code)

Plant safety induction evidence aligned with the OSH audit code.

SEBI BRSR

Workforce training disclosure for listed pharma manufacturers, BRSR Principle 3 and 5.

Who buys for Pharma

The heads behind the Pharma buying decision.

EHS HeadSafety / HSE Manager

Pain: Schedule M 2024 pressure. Per-batch induction trail demand. MSIHC for the MAH unit. No way to prove anything to the assessor.

Zentry answer: 3-minute kiosk induction enforced at every gate. Certificate validity verified at every cleanroom door. Per-batch trail ready in seconds.

Compliance HeadRegulatory / GRC

Pain: CDSCO Schedule M, MSIHC, §41B, IS 14489, BRSR each have different evidence asks. Compiling one pack used to take a week.

Zentry answer: One export per regulation. Per-period, per-zone, per-contractor, per-batch. Ready in minutes.

Plant HeadGM Operations / VP Plant

Pain: Safety incident traceability is paper-based. Insurance posture suffers.

Zentry answer: Per-worker, per-zone, per-shift trail. Incident forensics become clean. Insurance posture improves.

Deployment

Recommended for Pharma.

Most Indian pharma GMP plants choose Hybrid Edge: contractor PII and induction evidence stays at the plant, while the multi-plant compliance console works over internet for the Group EHS or Compliance Head. Fully air-gapped On-Premise available for plants with stricter data-sovereignty requirements.

Cloud

Fastest deploy. India-resident, multi-AZ. Multi-plant console.

  • Runs in the cloud, devices connect via plant network
  • Central console for multi-plant analytics
  • Automatic updates and patching
Best for

Multi-plant operators, auto Tier-1, IT-mature plants

On-Premise

Fully air-gapped. Zero internet. Maximum data sovereignty.

  • Runs entirely offline at the plant
  • All data, all logs, all evidence stays at the plant
  • USB / LAN-only updates
Best for

MAH chemical plants, MSIHC-regulated units, defence-adjacent supply chain

Customer outcome

Anonymised composite story

100% gate-anchoredSchedule M 2024 contractor induction

Pre-Zentry, the pharma GMP plant in Hyderabad tracked contractor induction through paper sign-off sheets in the EHS cabin. The auditor could not verify whether an actual induction happened, or whether the sheet was signed at the end of the shift. Post-Zentry, every contractor on the cleanroom floor carries a valid Induct certificate verified at the Gate event. The Schedule M 2024 surveillance audit closed in 2 days with zero non-conformance on induction evidence. Composite story drawn from real deployments. Industry, geography and metrics are representative.

All case studies
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We'll show you Zentry in the context of your Pharma plant, your audit calendar, your existing stack.

Pharma FAQ

Inspector and customer-auditor questions, plainly answered.

How does Zentry satisfy the Schedule M revised 2024 induction trail requirement?

Induct delivers the 3-minute kiosk induction with on-screen exam at the plant gate. The certificate is QR-coded, signed, and validated at every Gate event before the worker enters the cleanroom. The chain is per-batch, per-contractor, per-zone, exportable as a single PDF for the CDSCO assessor.

Can Zentry run fully air-gapped for our pharma plant?

Yes. The On-Premise tier runs entirely without internet. All worker data, all induction records, all access logs stay at the plant. USB or LAN-only updates. Suitable for the strictest data-sovereignty pharma operations.

How does Zentry handle MAH-classified pharma units?

Induct enforces hazard-zone induction with signed acknowledgment before MAH-zone access. Gate verifies the acknowledgment at every zone entry. Per-shift, per-zone, per-MAH-unit evidence chain for the §41B inspector.

Does Zentry produce BRSR-ready workforce training records?

Yes. Learn exports the workforce training pack matching the SEBI BRSR Principle 3 and 5 disclosure format. Per-period, per-worker-category, per-training-type. CFO sign-off in days, not weeks.

How does Zentry support batch-level traceability for our GMP audit?

Every contractor's induction, training, and access log can be filtered by batch ID. The Schedule M assessor asks 'who was on Batch 14 floor on April 11', the answer comes in one filter.

What languages does the induction kiosk support for our shop floor?

English plus 10 Indian languages: Hindi, Marathi, Tamil, Telugu, Kannada, Malayalam, Bengali, Gujarati, Punjabi, Odia. Workers pick their language at the kiosk.

How do we handle re-induction after process or SOP changes?

Configure re-induction triggers in Induct: after N months, after an incident, on SOP change, on zone reclassification. The system tracks each trigger independently and blocks expired certificates at the Gate.

How long does a Schedule M 2024 ready deployment take?

A single-plant Sitewide+ deployment with Pass, Gate, Induct and Learn goes live in 6 to 8 weeks. The induction content library typically takes 2 weeks to localise to the plant. For multi-plant Groups, the rollout is sequenced plant-by-plant.

How it all connects

One event. Six audit narratives.

Every gate read, every kiosk submission, every certificate validation lands in a single tamper-evident, signed log. From that one event, six modules produce six distinct evidence trails, for six different audits, six different inspectors and six different heads inside the plant.