ERP for pharma — built to pass audits, not just demos.
Pharma manufacturing has a higher bar than most ERP categories. 21 CFR Part 11. Schedule M. Batch traceability that survives a regulator's inspection. FEFO and shelf-life management without manual workarounds. We've built ERPs that hold up to all of it.
Built for pharma businesses where the regulator is the real customer.
Pharma ERP isn't a SaaS subscription decision. It's an audit-defence decision. The wrong system creates regulatory exposure that takes years to clean up. The right system passes inspections without your QA head losing a weekend.
- Manufacturers running CDSCO / WHO-GMP / EU-GMP audits with ERP audit trails that the inspector picks apart
- Distributors mixing batches at the warehouse without traceability — and discovering it during a recall investigation
- QC teams maintaining BMR/BPR in PDF templates that production updates by hand at end of shift
- Companies still using Tally + Excel for batch tracking, hoping nothing gets recalled
- Owners who tried SAP B1 pharma vertical and bounced off the implementation cost and timeline
- Production planners working from yesterday's data because the ERP doesn't have real-time WIP visibility
Modules built for pharma operations, not adapted from general manufacturing.
Every module below has been deployed in real Indian pharma operations and survived audit scrutiny. Generic ERPs sold to pharma typically need ₹20L+ of customisation to reach this level.
Batch & lot traceability
Every material movement tied to batch and lot. Forward and backward traceability: given a finished batch, trace to every raw material lot; given a raw material lot, find every finished batch it touched.
21 CFR Part 11 audit trails
Immutable audit logs. Electronic signatures with secondary authentication. User action logging. Time-stamped and tamper-evident — meets US-FDA expectations.
BMR / BPR digitisation
Batch manufacturing and batch packing records native in the system. Configurable per product. Approval workflows. No more paper templates floating between QA and production.
FEFO inventory & expiry alerts
First-expiry-first-out at every stock issue. Configurable shelf-life by product. Alerts well before expiry hits operational risk.
Quality control workflows
In-process checks, raw-material release, finished-goods QC, COA generation, deviation handling, OOS investigation tracking — built into operations, not a parallel system.
Recall management
Trace forward from a batch in seconds. Generate recall lists by customer, lot, and channel. Audit the recall response after.
Validation-first. Speed second.
GMP-aligned development
Pharma ERP isn't built with the same shortcuts as regular SaaS. We work to GAMP 5 principles — risk-based validation, design qualification, installation qualification, operational qualification. Test scripts mapped to user requirements. Documentation that supports audit defence.
On-prem when needed
Many of our pharma clients require fully on-prem deployment for compliance and data sovereignty. We support that — our pharma ERP runs on-prem, in your private cloud, or air-gapped if your regulator requires. Same software, your control.
We have built pharma ERPs for these sub-sectors.
Direct answers.
Is your pharma ERP 21 CFR Part 11 compliant?
Yes — immutable audit trails, electronic signatures with secondary authentication, user action logging, time-stamped and tamper-evident records. We provide validation documentation to support FDA, EU-GMP, and CDSCO inspections.
Can the ERP be deployed on-premise?
Yes — many pharma clients require on-prem deployment for compliance, data sovereignty, or audit reasons. We support fully on-prem, hybrid, your private cloud, or air-gapped deployments.
How long does pharma ERP implementation take?
Typically 20–32 weeks for a comprehensive deployment with validation. Smaller scope (e.g. just batch traceability + QC) can be live in 14–18 weeks. Full multi-site rollouts with validation documentation can run 6–9 months.
Do you handle CDSCO and WHO-GMP audit preparation?
Yes — our ERP comes with validation documentation packs, audit trail reports, and electronic signature workflows that auditors expect to see. We have supported clients through CDSCO, WHO-GMP, EU-GMP, and US-FDA inspections.
Will it integrate with our existing systems?
Yes — bi-directional integration with Tally, SAP, Oracle, Bizom, LIMS systems (LabWare, STARLIMS), and weighing-scale/PLC/SCADA on the production floor. Integration scope is part of the discovery phase.
Need pharma ERP that holds up to inspection?
30-minute scoping call. We will tell you honestly whether your current ERP can be patched up or whether a rebuild is the lower-risk path.