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Batch Records — Chemical Pharma ERP

Run electronic batch manufacturing records with full audit trails and e-signatures — paperless, compliant, review-by-exception.

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The batch record, done right and paperless

In pharma and chemicals, the batch record is the legal proof that a batch was made correctly. Paper records are slow to complete, error-prone, and a nightmare to review — and a single missing signature or entry can hold a batch from release.

This module replaces paper with electronic batch records: every step, weighing, check and signature captured in sequence, with a complete audit trail and e-signatures. Deviations are flagged as they happen, so QA reviews by exception instead of re-reading every page.

It connects directly to the rest of your Chemical Pharma ERP, and can be extended with AI or mobile apps for field teams.

What the module handles

The electronic batch record, end to end

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Electronic batch records
Execute the master batch record step by step, electronically.
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E-signatures
Capture role-based electronic signatures at each control point.
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Full audit trail
Record who did what and when, immutably.
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Deviation flagging
Flag out-of-limit steps and deviations in real time.
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Review by exception
Let QA review only the exceptions, not every entry.
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Master batch records
Version and control master records and templates.
Our Process

How it works

From master record to a released, exception-reviewed batch.

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1
Issue MBR
Release the master batch record.
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2
Execute steps
Record each step and check.
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3
Sign off
Capture e-signatures at controls.
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4
Flag deviations
Surface out-of-limit steps.
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5
QA review
Review exceptions only.
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6
Release
Approve and release the batch.

What it changes for your business

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Faster batch release
Review-by-exception and complete records cut release time dramatically.
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Fewer record errors
Guided electronic entry removes missing signatures and gaps.
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Always audit-ready
Immutable audit trails and e-signatures satisfy inspectors.
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Less paper, less risk
Paperless records remove transcription and archival risk.

Who it is for

Regulated manufacturers that must prove every batch:

Pharma formulation plantsAPI & bulk-drug makersSpecialty chemical producersNutraceutical manufacturers

Batch Records — frequently asked questions

Does it support electronic batch records with e-signatures?

Yes. The master batch record is executed electronically step by step, with role-based e-signatures at control points and a complete, immutable audit trail.

Can QA review by exception?

It can. Deviations and out-of-limit steps are flagged in real time, so QA reviews only the exceptions rather than re-reading the entire record, which greatly speeds release.

Is it 21 CFR Part 11 aligned?

The audit trails, e-signatures and controlled records are built to support 21 CFR Part 11 expectations, and work alongside the Regulatory Compliance module.

Does it reduce batch release time?

Yes. Guided electronic entry plus review-by-exception removes the delays of paper completion and full manual review, so compliant batches release faster.

See Batch Records in your Chemical Pharma ERP

See Batch Records take your batch manufacturing paperless and compliant — book a demo mapped to your MBRs.

Request a Demo →