Catalyst Electronic Batch Manufacturing Record
A paperless BMR platform that captures data directly from machines, instruments and ERP'sfully compliant with FDA 21 CFR Part 11.
Paperless Batch Manufacturing, End to End
Catalyst eBMR is an innovative, easy-to-adopt and user-friendly electronic batch manufacturing record software built for the pharmaceutical, biotech and medical device industries. It replaces paper batch records with a validated, audit-ready digital workflow.
One of the biggest challenges in going paperless is migrating existing records. With Catalyst eBMR, that transition is seamless — an inbuilt BMR designer and paper-to-electronic migration tool lets you recreate approved paper BMRs digitally, without re-engineering your process.
The platform integrates with your existing ERP, machines, PLCs and instruments to create a truly paperless shop floor. It also connects natively with the rest of the Catalyst suite — QMS, eLogBook, Calibration & Maintenance and APQR — helping you build a future-ready, Pharma 4.0 manufacturing facility.
What Makes Catalyst eBMR Different
Purpose-built functionality that has easy implementation, smooth integration, reduces operator error and keeps every batch inspection-ready.
Key Features
- • Paper-to-Electronic BMR Migration Tool - Convert approved paper batch records into validated electronic templates using the inbuilt designer. No coding & no process re-validation surprises.
- • Complete eBMR with E-Signed PDF Output - Generate the full batch record automatically, including a final, electronically signed and tamper-evident PDF for review, release and archival.
- • FDA 21 CFR Part 11 Compliant by Design - Role-based access control, electronic signatures, secure time-stamped audit trails and full data integrity aligned to ALCOA+ principles.
- • Rules & Formulas Creator - Automate yields, reconciliation, in-process checks and acceptance criteria so calculations are consistent, traceable and free from manual error.
- • Alerts & Warnings on Data Entry - Real-time validation flags out-of-specification entries, missing fields and out-of-sequence steps before they compromise the batch.
- • Real-Time Device & ERP Integration - Acquire data directly from machines, weigh scales, sensors and instruments, and exchange master and batch data with your ERP for a paperless shop floor.
Catalyst eBMR enables organisations to move from traditional paper batch manufacturing records to a fully automated, secure and compliant digital system. Its intuitive design shortens the learning curve, so teams are trained faster while global regulatory expectations — including FDA 21 CFR Part 11, EU GMP Annex 11 and ALCOA+ data integrity — are consistently met.
Complete eBMR with e-signed PDF output.
Automatic batch numbering.
Parallel Operations by Multiple Depts.
Easily create new eBMRs.
Native integration with ERP, PLC/SCADA, Machines and instruments
Formulas and Rules editor
Frequently Asked Questions (FAQ's)
What is an Electronic Batch Manufacturing Record (eBMR)?
An Electronic Batch Manufacturing Record is the digital equivalent of a paper BMR. It guides operators through each manufacturing step, captures critical process parameters and in-process results, enforces specifications automatically, and produces a complete, electronically signed batch record for review and release.
Is Catalyst eBMR compliant with FDA 21 CFR Part 11?
Yes. Catalyst eBMR is designed for FDA 21 CFR Part 11 and EU GMP Annex 11 compliance, with role-based access control, electronic signatures, secure time-stamped audit trails and ALCOA+ aligned data integrity controls.
Can we migrate our existing paper BMRs into Catalyst eBMR?
Absolutely. The inbuilt BMR designer and paper-to-electronic migration tool let you convert approved paper batch records into electronic templates quickly, so you can go live without disrupting validated manufacturing processes.
Does Catalyst eBMR integrate with ERP, machines and instruments?
Yes. Catalyst eBMR integrates with ERP systems for master and batch data, and connects directly to machines, PLCs, weigh scales, sensors and laboratory instruments for automatic, error-free data acquisition.
How does eBMR improve data integrity?
Every entry is validated in real time against predefined rules and specifications. Out-of-range values trigger alerts, all changes are captured in an immutable audit trail, and records are e-signed — eliminating transcription errors, illegible entries and missing signatures.
Ready to Go Paperless with Your Batch Records?
See how Catalyst eBMR converts your existing paper BMRs into compliant, fully digital batch execution — and how it fits into your wider Pharma 4.0 roadmap.
Schedule a Free Demo