Schedule M 2024 CDSCO surveillance closed in 90 minutes.
Integrated pharma plant, Hyderabad · Hyderabad-Vizag
A 2,800-worker integrated pharma plant in Hyderabad serving regulated US and EU markets faced the Schedule M revised 2024 documentation upgrade. Whiteboard inductions and paper sign-off sheets would no longer pass CDSCO surveillance. Post-Zentry Sitewide+, every contractor entering the cleanroom carries a live, gate-verifiable GMP induction certificate. The next surveillance closed in 90 minutes with zero documentation findings.
| BATCH 2024-184 | Cleanroom 3A | Validated |
| CONTRACTORS | Induction current | 2,160 / 2,160 |
| STAFF GMP | Training current | 640 / 640 |
| CDSCO PACK | Last 12 months | Ready |
| CLRA FORMS | All agencies | Generated |
| BRSR | Live metrics | Yes |
| WORKSHEET | Project P&L live | ₹14.2 Cr |
What the plant was facing.
The Schedule M revision in 2024 changed the documentation bar for Indian pharma GMP plants. The contractor induction trail became a hard requirement: every worker on the cleanroom floor needed a current, signed, gate-verifiable induction certificate. The plant's existing process was a whiteboard induction in the security cabin and a paper sign-off sheet retained by the contractor agency. CDSCO surveillance inspectors had started asking for the per-batch induction trail. The plant's compliance position was exposed.
The plant ran six separate systems: visitor book, ZKTeco biometric, paper vehicle register, whiteboard induction, an external LMS subscription for staff training, and project P&L spreadsheets. Quarterly BRSR data collection was a six-week scramble. The Group CFO had asked for consolidated project P&L across plants but the Hyderabad plant could not produce it without manual reconciliation.
How Zentry was deployed.
Zentry Sitewide+ deployed across all six modules. On-Premise tier was chosen to satisfy the US regulator's data residency clause and the internal GMP infrastructure standards. The existing ZKTeco biometric stayed in place. Induct kiosks were installed at every gate, configured with the plant's specific GMP induction modules. Learn ingested the plant's existing training matrix. Worksheet integrated with the plant's Tally project ledger.
The Zentry modules in this deployment.
Pass™
Visitor management at the kiosk.
Explore Pass →Gate™
Access + contractor attendance, Forms XIII to XXIII.
Explore Gate →Drive™
Vehicle, parking, ANPR + GST e-Way Bill match.
Explore Drive →Induct™
3-minute safety induction at the kiosk.
Explore Induct →Learn™
Role-based industrial LMS + BRSR records.
Explore Learn →Worksheet™
Project P&L + gate-anchored hours.
Explore Worksheet →What Zentry Sitewide+ produced for the plant:
Per-batch contractor induction certificate validated at the gate. Cleanroom access blocked if certificate has expired or is missing. CDSCO inspectors verify the chain from gate event back to induction kiosk session.
DPDPA-compliant visitor management with explicit consent and India-resident storage. CDSCO inspector check-in via kiosk.
CLRA Forms XIII to XXIII auto-generated. Per-agency, per-period.
Role-based GMP training records for staff. SEBI BRSR training metrics live, no annual scramble.
Project P&L tied to gate-anchored hours. Group CFO sees consolidated project margin live.
Inbound API and raw material vehicle traceability matched to e-Way Bill.
The metrics that moved.
What happened at the next audit.
The first CDSCO surveillance audit post-Zentry closed in 90 minutes with zero documentation findings. The State Drug Controller inspection that followed closed in 60 minutes. USFDA preparation tracks ahead of schedule for the next FDA cycle. The Group CFO sees consolidated project P&L across plants for the first time, live.
"Schedule M 2024 raised the bar. We were exposed. Six systems, six narratives, no way to demonstrate the induction trail to CDSCO. Zentry Sitewide+ on On-Premise gave us the GMP-grade chain we needed. The first surveillance closed in 90 minutes. The CDSCO inspector commented that the induction-to-gate trace was the cleanest he had seen at an Indian pharma plant."All case studies →
Request a reference call.
We can connect you with a Plant Head or EHS Head at a similar plant under NDA. Hear the story from the customer, not the salesperson.
Common questions on this deployment.
Why was On-Premise the chosen deployment tier?
Two reasons. The US regulator (USFDA) requires data residency at the plant for the regulated GMP infrastructure. The plant's internal IT posture for GMP-relevant systems is also air-gapped. On-Premise satisfies both. Cloud was not in scope for this plant.
How does Zentry handle per-batch GMP induction at the cleanroom entry?
Induct kiosk runs the GMP induction module specific to that batch's API or formulation. The worker takes the on-screen exam, passes, gets the certificate. The certificate is tagged to the worker, the batch, the cleanroom zone, and the validity window. At the cleanroom entry gate, the certificate is validated live. Access blocked if expired or missing.
Is this a real customer or a composite?
Composite story drawn from real Zentry deployments at integrated pharma plants in Hyderabad and Visakhapatnam. Industry, geography and metrics are representative. Named references are available under NDA during qualification.
Did the deployment disrupt the existing GMP qualification posture?
No. The Implementation team worked with the plant's QA function to ensure the platform itself qualified under the plant's GMP infrastructure validation requirements. The validation package was produced as part of the deployment.
How long did the full Sitewide+ deployment take?
12 weeks from contract signature. On-Premise tier adds 2 to 3 weeks for air-gapped commissioning versus a Cloud baseline. The validation package added another 2 weeks to the timeline but was scheduled in parallel.
Has the plant seen TCO benefit from consolidating six vendor stacks?
Yes. AMC spend dropped 42%. The bigger benefit was operational: audit prep time dropped 76%, BRSR data collection moved from a six-week scramble to a live dashboard, project P&L is now consolidated live for the Group CFO.
Can other pharma plants reference this deployment?
Yes, under NDA during qualification. The reference plant typically hosts a 30-minute call with the prospect's Plant Compliance Head and QA Head, and a separate technical call for the GMP infrastructure team.
Does Zentry handle the upcoming Schedule M phase-2 deadlines?
Yes. The platform was architected for the revised 2024 framework. Phase-2 deadlines and any subsequent CDSCO clarifications are tracked by the Care team and pushed as platform updates within the validation envelope.
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.