Pharma & Life Sciences · Batch record automation
Every batch release waits on a reviewer checking values that were already captured somewhere else
Banao builds electronic batch record systems for pharmaceutical manufacturers — pulling values from instruments, PLCs, and LIMS directly into the record, flagging deviations the moment they occur, and generating a closed record a QA reviewer can sign on the day the batch completes.
Every system is built with computer-system validation in mind from the first data model: documented requirements, versioned logic, a full audit trail on every field write, and human authorisation at each step the regulation expects a person.
The first call is free · 45 minutes · no obligation
What we build
What a Banao eBR deployment includes
A batch record system is not a form — it is an integration across instruments, process controls, and quality systems. We own all three.
Instrument and PLC data pull
Temperature logs, pH readings, weight checks, and critical-process parameters pulled from instruments and PLCs directly into the record field — no manual transcription, no transcription error.
Real-time deviation flagging
Out-of-specification readings and missing step completions surface in the batch record the moment they happen, not during end-of-batch review when the options for correction are narrowest.
Review-by-exception close
The system pre-populates every field it can verify from an electronic source. Reviewers see only the items that need a human decision — not a hundred-page record to check line by line.
21 CFR Part 11 and Annex 11 audit trail
Every field write, override, and sign-off is logged with user identity, timestamp, and reason for change — in a format that answers a regulatory inspector's first three questions before the second page.
LIMS and MES integration
Batch records pull from and push to your LIMS and MES. The record does not exist in a silo; it closes the data loop back into your quality and operations systems.
Legacy instrument digitization
For instruments with no digital output, Banao adds a digitization layer — paper scan with structured extraction, or a lightweight serial interface — so instrument age does not block automation.
Dogfooding
We run operational AI before you do
Banao operates a ~300-person engineering company on its own AI products. InterviewGod screens every engineering hire. Vikaas runs our demand-generation pipeline. We do not ship a system to a client before we have lived on an equivalent one ourselves.
That matters for batch record automation specifically: a system that has to survive our own operations review — and our own quality bar — is already hardened before it reaches a validated pharmaceutical process.
Screens every Banao engineering hire end to end.
Runs Banao's own demand-gen pipeline daily.
The honest version
When batch record automation doesn't pay back
Not every manufacturing site gets a return on a full eBR system. We will say so before you fund it:
- Very low batch volume: if you run a handful of batches per month with a stable team and a process rarely under audit pressure, the validation overhead can outweigh the manual-record cost. A risk-based assessment tells you where the line is.
- No digital signal from instruments: if your instruments have no electronic output and no scannable output, week one is instrument interface engineering, not software. We price that upfront, not as a change request.
- Underlying process not ready: an eBR system does not substitute for a validated process. If your SOPs and process controls are not in order, the eBR records the gaps more accurately — which is not a benefit during an inspection.
How we start
How we start — see the automation map before you commit to a build
We walk your existing batch manufacturing record field by field before writing a line of code.
- 01
AI Discovery Sprint
2 weeks · fixed price
We map each field in your master batch record: which can be pulled from existing instrument or PLC outputs, which need a digitization step, and which stay manual by design or by regulation. You get a prioritised automation map, a validation-burden estimate per field group, and a go/no-go — yours to keep either way. If you proceed, the Sprint cost is credited against the build.
- 02
Build
Instrument interfaces and data pipelines first, then the eBR application. We build audit-trail and versioning into the data model from day one, and integrate with your LIMS, MES, and quality systems. Validation documents are part of scope, not an add-on.
- 03
Production
Deployment with user-acceptance testing, change management for batch team operators and QA reviewers, and go-live support through the first batches. The system is documented, trained on, and signed off before you close the first batch in production.
FAQ
Frequently asked questions
Does an eBR system need to be validated under GxP?
Yes — any system that creates, modifies, or authorises data that GMP regulations require is in scope for computer-system validation. Banao builds the system to that standard from the start: documented requirements, risk assessment, test protocols, and a signed validation package as a deliverable, not an afterthought.
What happens to our existing paper batch records during cutover?
They stay in place. The eBR system goes live batch-by-batch, starting with one or two product families where the instrument interface is cleanest. You run paper and electronic in parallel until QA signs off the new system — then the paper master goes to archive.
Can you integrate with our specific LIMS or MES?
We have built interfaces for a range of LIMS, MES, and process control systems. If yours is not on our standard list, the Discovery Sprint includes an interface feasibility read. Custom interfaces are part of the build deliverable, not a separate change request.
How do you handle instruments with no digital output?
Two paths: a structured paper-scan and extraction layer for instruments that print only, or a lightweight serial or USB interface retrofit for instruments that have an output but no existing integration. The Discovery Sprint maps which applies to each instrument in your process.
How long does a batch record system take to go live?
It depends on instrument count, product complexity, and how close your LIMS and MES already are to the eBR interfaces. A single-product, well-instrumented line can reach production in three to four months. A multi-product site with legacy instruments takes longer. The Discovery Sprint produces a timeline grounded in your actual process, not a brochure estimate.
Get started
Bring your most complex batch record to the first call
In 45 minutes we will tell you which fields can be automated from your existing instruments, where the validation cost sits, and whether an eBR system earns its keep on your site.
Book a Discovery Sprint