📋 Chemical & Pharma ERP: Batch records
Run electronic batch manufacturing records step by step. Weights come straight from the scale, every step is signed, out-of-limit values open a deviation on the spot, and QA reviews only the exceptions.
Hover or tap a row. On the left, the mistake QA finds on paper. On the right, why it can't happen in an electronic record.
Pick a material and a lot to scan, then add material. The record only accepts a released lot and a weight inside the tolerance.
Material
Lot scanned
The system checks every entry against its limits as it happens. Here's the fluid bed dryer in batch B-2410: one excursion, flagged and turned into a deviation. Demo data.
0 entries checked automatically
Pick any lot, pack or customer. The record shows everything linked to it, which is what you need to scope a recall.
The nine data-integrity principles regulators look for, and how the record meets each one.
Every entry is tied to one named login. No shared accounts.
Typed and structured entries, so nothing is unreadable.
Entries are stamped with server time as the step happens.
The first capture is kept, including readings sent straight from scales and instruments.
Limits, calculations and scale links remove transcription errors.
A batch can't be released while any step, check or signature is open.
Steps run in the order of the master record, with time and date in sequence.
Records are kept in validated storage for the full retention period.
Any batch can be pulled up in seconds for QA, auditors or a recall.
Signatures, captures, corrections and flags arrive as they happen. Nothing is deleted. Demo log.
Corrections keep the old value and the reason. Flags come from the system, not from a person remembering to write them down.
What each one asks of batch records, and where it's handled in the suite.
Nine capabilities, each linked to the related module or service.
Send us one of your paper batch records. We'll show it running as an electronic record in a live demo.
Convert my BMR in a demoSee the Chemical & Pharma ERPSix steps to go paperless.
What changes once batch records run electronically.
QA reviews exceptions instead of reading every page.
No missing signatures, blanks or bad maths.
Audit trails and e-signatures for every entry.
Genealogy shows exactly which packs went where.
From one tablet line to multi-site contract manufacturing.
One integrated system.
Industries and services connected to batch records.
Answers for QA heads, plant managers and IT teams.
It's the batch record kept in software instead of on paper. Operators follow the master record step by step, weights and readings come straight from equipment, each step is signed electronically and every entry is in the audit trail.
Instead of QA reading every page of every batch, the system checks limits as entries are made and shows QA only what went outside them: deviations, corrections, late steps or overrides. Everything else is already proven complete and within limits.
It's built for them: unique logins, e-signatures linked to the record with meaning and time, secure audit trails, access control and validated storage. Compliance also depends on your validation and procedures, which we support with IQ, OQ and PQ documents.
Yes. Revised Schedule M asks for controlled batch manufacturing and packing records for every batch. The system produces them complete, signed and ready for inspection.
Yes. Balances, scales, and machine data from PLCs or SCADA can feed readings straight into the record, so nobody types a weight.
An entry is never overwritten. A correction keeps the original value, the new value, the reason and who made it, and may need a second signature.
As long as your rules need. US rules ask for at least one year after the batch's expiry date, and many companies keep records longer. The retention period is set per record type.
Yes. Genealogy links raw material lots to the batch, packs and the customers who received them, so you can see the exposure in both directions.
As an estimate, 8 to 14 weeks for one plant, including validation. It depends on how many master records you have and how many machines need connecting.
Tell us your products, lines and how you keep batch records today. We reply within 4 business hours and can demo with one of your own records.