In Pharma, a Batch Tracking Gap Isn't a Process Issue. It's a Regulatory Risk.

Complete batch genealogy — forward and backward traceability from raw material receipt to patient sale — integrated QC workflows, automated compliance documentation, and regulatory reports that are always audit-ready, not compiled in panic.

100%
Batch Traceability
0
Compliance Findings
60%
Less Expired Write-Offs
The Problem

Does This Sound Familiar?

Every one of these is a solvable process and technology problem — not a “we need more staff” problem. These are the challenges our healthcare & pharma clients face before working with us:

01

Batch Traceability Gaps During Regulatory Audits — Your Worst Nightmare

A regulatory inspector asks: 'Show me the complete batch genealogy for Batch #PH-2026-0782 — from which supplier lots of raw material were used, to which customers received the finished product.' Your team spends 4 hours searching through paper records, ERP screens, and QC logs. One missing link in the chain and you have a Form 483 observation — or worse, a warning letter. Batch traceability isn't a feature. It's your license to operate.

02

Expired and Near-Expiry Stock Discovered During Audits — Not Prevented Proactively

Every quarter, your warehouse 'discovers' stock worth ₹5-10 Lakhs that expired last month — products that could have been sold at a discount or redistributed if identified 90 days before expiry. Your ERP tracks batch numbers but doesn't proactively alert on approaching expiry. By the time someone notices, the stock is scrap.

03

Quality Control Documentation Is Manual, Time-Consuming, and Error-Prone

QC test results are recorded on paper forms, transcribed into Excel, reviewed by a QC manager, and filed. When an auditor asks for the QC records of Batch #X from 18 months ago, someone spends 2 hours searching through filing cabinets. Test result trends that could indicate a process drift go unnoticed because data sits on paper, not in an analytics system.

04

Regulatory Filings Are Compiled in Panic Mode Before Every Deadline

Drug license renewals, Schedule M compliance documentation, FDA/MHRA submission data — each requires pulling data from 5 different systems, formatting it manually, and praying nothing is missing. The person who knows how to do this is on leave during filing week. Again.

The Solution

We implement ERP systems specifically configured for regulated manufacturing — where every batch is tracked from raw material receipt through production to customer delivery, QC test results are captured digitally and linked to batches, expiry alerts fire 90/60/30 days before expiration, and regulatory reports are generated from live data — not compiled from paper records.

Healthcare & Pharma solution

What We Deliver for Healthcare & Pharma

Detailed breakdown of what you get, how we do it, and what the result looks like.

01

Complete Batch Genealogy — Forward & Backward Traceability

Trace any finished product back to its raw material lots, and forward to every customer who received it — in seconds

We configure your ERP (BC or ERPNext) with end-to-end batch tracking. Every raw material receipt is assigned a batch/lot number. During production, material consumption is recorded against specific batches. Finished goods are assigned batch numbers that link back to all input batches. Sales orders record which customer received which batch. The result: complete forward and backward traceability — available in seconds during any audit.

What You Get

Raw material batch tracking: every receipt is assigned a batch number with expiry date, supplier details, and QC status
In-process batch tracking: WIP batches track which input material lots were consumed — with automatic lot selection (FEFO/FIFO)
Finished goods batch genealogy: one click → see every raw material batch that went into this finished batch
Forward traceability: one click → see every customer who received product from this batch → initiate recall if needed
Electronic batch records (EBR): complete production batch history — materials consumed, equipment used, operators, QC results, deviations

Real Scenario

A pharma manufacturer received a supplier alert about a potential impurity in a specific raw material lot. Using their ERP's batch genealogy, they identified every finished goods batch that used that raw material lot, every customer who received those batches, and every distributor who further sold them — within 8 minutes. They initiated a targeted recall before any patient was affected. The regulator commended their traceability system during a subsequent inspection.

02

Automated Expiry Management & FIFO/FEFO Enforcement

Never lose stock to unnoticed expiry again — proactive alerts and system-enforced picking logic

We configure expiry date tracking on every batch with automated alerts at configurable thresholds (e.g., 90, 60, 30 days before expiry). Warehouse picking is enforced as FEFO (First Expiry, First Out) — the system won't allow picking a batch with 12 months of shelf life when a batch with 6 months is available. Near-expiry stock is automatically flagged for discount, redistribution, or destruction as per your SOP.

What You Get

Expiry date tracking on every batch: captured at receipt, visible on every transaction, never hidden
FEFO picking enforcement: system directs pickers to the earliest-expiring batch — no manual override without supervisor approval
Automated expiry alerts: 90 days → sales team notified to prioritize, 60 days → discount approval workflow triggered, 30 days → quarantine and destruction workflow
Expiry dashboard: all batches approaching expiry across all warehouses — color-coded by urgency
Write-off reduction analytics: track expiry write-offs by product, warehouse, and root cause — continuously improve

Real Scenario

A pharma distributor was writing off ₹8-12 Lakhs annually in expired stock — discovered only during annual stock counts. We configured automated expiry alerts in their ERP. Now, 90 days before expiry, the sales team gets a notification to prioritize that batch. 60 days: a discount approval workflow is triggered automatically. 30 days: stock is auto-quarantined. Expiry write-offs dropped 60% in the first year — saving ₹5-7 Lakhs.

03

Digital QC Lab — Test Scheduling, Results Recording & Certificate Generation

QC workflows integrated with production — test results captured digitally, certificates auto-generated, trends analyzed

We build digital QC workflows within your ERP. When a production batch is created, QC tests are auto-scheduled based on the product's QC specification. Test results are entered digitally (with e-signatures where required). Certificates of Analysis (CoA) are auto-generated. And QC data is available for trend analysis — identifying process drift before it causes batch failures.

What You Get

QC specification master: define tests, methods, acceptance criteria, and sampling plans per product and per stage (raw material, in-process, finished)
Auto-scheduled QC tests: when a production order is created, QC samples and tests are auto-generated — no manual test request forms
Digital result entry with electronic signatures: test results entered directly into the ERP, reviewed and approved online, audit trail on every change
Auto-generated Certificates of Analysis: CoA with all test results, acceptance criteria, and pass/fail decision — formatted for customers and regulators
QC trend analytics: control charts (X-bar, R-chart), process capability (Cp/Cpk), out-of-specification (OOS) investigation tracking

Real Scenario

A pharma manufacturer's QC lab was recording test results on paper — 200+ tests per day across raw materials, in-process, and finished products. Compiling monthly quality review reports took 5 days. We digitized their QC workflows in ERPNext. Test results are now entered directly into the system, CoAs auto-generate, and the monthly quality review report is produced in 4 hours — with trend charts that caught a dissolution test drift 3 weeks before it would have caused a batch failure.

Why Choose Dhaara Over a Regular ERP Vendor

What Most ERP Vendors Offer
What Dhaara Delivers
Generic ERP without batch genealogy — basic lot tracking, no raw material-to-customer linkage
Complete batch genealogy: raw material receipt → production consumption → finished goods → customer delivery — forward and backward traceable in seconds
Manual QC documentation — paper forms, Excel compilation, filing cabinets
Digital QC workflows: auto-scheduled tests, digital results with e-signatures, auto-generated CoAs, trend analytics
Expiry management by manual warehouse checks — discovered after expiry
Automated expiry alerts at 90/60/30 days with enforced FEFO picking and auto-quarantine workflows
Basic GST filing — generic, not pharma-specific
Pharma-specific compliance: Schedule M documentation, drug license integration, FDA/MHRA submission support
Measurable Outcomes

What Our Clients Typically Achieve

100%

Batch traceability — forward and backward — any batch query resolved in under 10 minutes during a regulatory inspection

60%

Reduction in expired stock write-offs through proactive 90/60/30 day alerts and system-enforced FEFO picking

4 Hours

Monthly quality review report generation — down from 5 days of manual data compilation and chart preparation

0

Audit findings related to traceability gaps or documentation inconsistency after implementation

8 Min
Batch Traceability Query
₹5-7L
Annual Expiry Savings
4 Hrs
Monthly QC Review
Pharmaceutical Manufacturing
API & Bulk Drug Manufacturing
Medical Devices
Hospital Supply Chain
Healthcare Distribution
Ayurvedic & Nutraceutical

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