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Industries / Pharmaceuticals

ERP, Software and AI Built for GMP Batch Tracking

A pharmaceutical batch moves through manufacturing, in-process QC, QA review and release, with documentation expected at every step. TCB Infotech tracks that batch record digitally, keeps it audit-ready, and connects it to the ERP you already run.

50+ ERP and software projects. Zero failed projects since 2021.

Batch #PH-2291
Amoxicillin 500mg Capsules
Manufacturing
Complete
In-Process QC
Complete
QA Review
In Review
Released
Pending
Illustrative batch record view
4
Release stages tracked, from manufacturing to release
100%
Scoped to your process before work starts
Zero
Failed projects since 2021
Full
Batch traceability from raw material to release
Why It Matters

A batch record is only as good as the tracking behind it

Paper logs and spreadsheets scattered across manufacturing, QC and QA slow release and complicate audits. Tracking the batch digitally, in one connected system, changes both.

GMP Production Reality

Every batch tracked through manufacturing, QC, QA and release

A batch record moves through manufacturing, in-process QC, QA review and release, and each step needs its own documentation. We build the system that tracks that movement as it happens, instead of reconstructing it after the fact.

  • Batch status visible at every stage.
  • In-process QC results tied to the batch record.
  • QA review and release recorded, not re-typed.
Manufacturing floor with batch data tracked digitally for GMP release
One System, Not Three

ERP, custom software and AI working off the same batch data

The batch record system connects to the ERP you already run, so material issue and consumption stay in sync, while AI flags batches heading toward a hold or a stability deadline before a person has to notice manually.

  • Batch data connected to your existing ERP.
  • AI flags exceptions for a person to review.
  • One team builds and supports all three layers.
Plant head reviewing batch and release status on a tablet
How It Works

From your current batch process to a running system

1
Map
We walk your production floor and map how batch records move today, from raw material issue to release.
2
Scope
We agree the ERP integration, software and AI pieces that fit your GMP process, with a fixed timeline.
3
Build
Batch record tracking, QC and QA workflows are built and tested against your actual batch data.
4
Launch
The system goes live on the floor and is watched closely through the first production cycles.
5
Support
The same team stays available for support and changes as your GMP process evolves.
What We Handle

Everything a GMP batch record needs to stay audit-ready

📋

GMP Batch Record Management

Batch records tracked from manufacturing start through release, replacing scattered logsheets with one connected record.

🧪

In-Process QC Tracking

In-process QC checks and results tied directly to the batch they belong to, visible as they happen.

✅

QA Review & Release Workflow

QA review and release decisions recorded against the batch record, with a clear approval trail.

📦

Raw Material & Packing Material Traceability

Raw material and packing material lots traced against every batch they were consumed in.

⌛

Stability & Expiry Tracking

Stability schedules and expiry dates tracked by batch, with upcoming deadlines flagged early.

📄

Audit-Ready Documentation

Batch documentation compiled as work happens, so an audit-ready record is a normal output, not a scramble.

What Changes

What GMP batch tracking changes for a pharmaceutical manufacturer

Aligned
Batch tracking matched to your actual GMP process
Traceable
Raw material to release traceability on every batch
Connected
Batch data connected to your existing ERP
Documented
Audit-ready records built into daily work
Visible
Release status visible across manufacturing, QC and QA
Zero
Failed projects since 2021
Why Us

Why pharmaceutical manufacturers run batch tracking through TCB Infotech

1
We build around your GMP process, not a template
The batch record system reflects how your manufacturing, QC and QA teams actually work, not a generic module you have to adapt to.
2
ERP, software and AI from one team
Integration, batch record software and AI exception flags are scoped and delivered together, not by separate vendors.
3
Direct access, no relay
You work directly with the engineers building your batch record system, on your own floor and data.
4
Support after go-live
The team that builds the system stays available for support and changes as your process or product mix evolves.
5
One contract for combined engagements
A project touching ERP integration, batch record software and AI at once is scoped as a single engagement.
6
Proven delivery
50+ ERP and software projects, with zero failed projects since 2021.
FAQ

Pharmaceuticals, Answered

What does TCB Infotech do for pharmaceutical manufacturers?
We connect your ERP, build the custom software your batch record and release process needs, and add AI where it removes manual tracking work, scoped around GMP manufacturing, in-process QC, QA review and release.
Does this replace our existing ERP?
No. The system connects to your existing ERP and accounting setup rather than replacing it. We build the batch record, QC and release tracking your GMP process needs and link that data back to the ERP you already run.
How does the system support GMP compliance and traceability?
The system tracks batch records from manufacturing through in-process QC, QA review and release, and keeps raw material and packing material traceability and documentation audit-ready. It supports the tracking and documentation a GMP process requires. It does not replace your quality team's or a regulator's judgment.
How long does a pharmaceutical engagement usually take?
Most engagements move from process mapping to a working pilot within a few months. Scope and timeline are confirmed after we walk your production floor and batch record process with you.
What support do we get after go-live?
The same team that builds the system stays available for support and changes as your GMP process, product mix or documentation needs evolve.
Can ERP integration, custom software and AI be combined into one engagement?
Yes. Most pharmaceutical engagements combine ERP integration, a piece of custom software for batch record or release tracking, and AI where it removes manual documentation work, scoped as one project.

Get GMP Batch Tracking Built Around Your Process

Batch, QC and release data spread across paper and spreadsheets slows release and complicates audits. Book a free consultation and walk us through your batch record process.

Book a Free Consultation →

No commitment. See a scope before you decide.

Industries / Pharmaceuticals Features

How We Build GMP Batch Tracking

From raw material issue to a released batch. Here is how batch records, QC and QA review, and ERP-connected traceability come together.

Core Process

Batch tracking, QC and QA review, and ERP connection, in that order

Batch Record Tracking

Every batch tracked from manufacturing to release

A batch record is opened at manufacturing start and carried through in-process QC, QA review and release, with each step logged against the same batch number instead of a separate paper trail.

  • One batch record from start to release.
  • Manufacturing, QC and QA steps time-stamped.
  • No re-entry between departments.
Quality team reviewing an in-process QC record
QC and QA Workflow

In-process QC and QA review built into the same record

In-process QC results feed straight into the batch record, and QA review and release run as a workflow against that record, so a batch cannot move to the next stage without the required sign-off being logged.

  • QC results linked to the batch, not a separate sheet.
  • Release workflow requires QA sign-off.
  • Holds and deviations recorded against the batch.
QA reviewing a batch record before release
Connected to Your ERP

Batch and material data linked back to your existing ERP

Raw material and packing material consumption recorded against a batch stays in sync with the ERP you already run, so stock and batch traceability do not have to be reconciled by hand.

  • Material consumption synced with your ERP.
  • Traceability data available on both systems.
  • No manual reconciliation between the two.
Checking batch documentation against ERP records
What We Handle

Everything a GMP batch record needs to stay audit-ready

📋

GMP Batch Record Management

One batch record carried from manufacturing start through release, with every step time-stamped and attributed.

🧪

In-Process QC Tracking

In-process QC checks, results and retest data all tied to the batch record they belong to.

✅

QA Review & Release Workflow

A release workflow that requires QA sign-off before a batch can move forward, with holds and deviations logged.

📦

Raw Material & Packing Material Traceability

Every raw material and packing material lot traced against the batches it was consumed in, both ways.

⌛

Stability & Expiry Tracking

Stability study schedules and product expiry dates tracked by batch, with upcoming deadlines flagged in advance.

📄

Audit-Ready Documentation

Batch documentation compiled from the same record used for daily work, ready to hand to an auditor without a separate compilation exercise.