Right first time.
Released faster.
Audit-ready always.
Replace paper batch records with step-by-step electronic records on the shop floor. Capture weights and checks from connected instruments, handle deviations properly, and let AI review every record so QA can release by exception.
Swipe the corridor to walk every zone
Seven zones. One batch record that tells the truth.
Walk the plant the way an operator does. Each zone has its own wall tablet, its own checks and its own sign-offs, and all of it lands in a single electronic batch record that QA can trust.
Master Recipes
Author master batch records once, route them through review and approval, and release only the effective version to the shop floor.
Superseded
Superseded
Effective
In review
MBR-PCM-500 · change control CC-0418 · approved by QA head
Batch Execution
Operators follow the approved recipe step by step on a tablet in each room.
150.030 kg
Within tolerance · ± 0.5%
Line Clearance
Run room and line clearance as checklists on the tablet at the door.
- Previous product removed
- Punches and dies changed
- Status labels replaced
- QA verified · 08:12
Equipment Logs
Equipment usage, cleaning, calibration and status logs kept electronically and linked to batches.
- RMG-01Clean · in use
- FBD-02Available
- BAL-11Calibration overdue
- COT-01Awaiting cleaning
Deviation Desk
When a value is out of limit or a time is exceeded, the deviation is raised from the batch step itself, with the context already attached.
Granulation drying time exceeded by 6 min
AI Batch Reviewer
The AI Batch Reviewer reads the complete batch record and highlights what needs a human: missing entries, missing second-person verifications, out-of-limit values, open deviations and unusual patterns.
412
entries checked
2
verifications sent back
0
out-of-limit values
Highlights only. QA makes every decision.
QA Release
QA opens a batch record that has already been checked, sees only what needs attention, and releases with an electronic signature.
Batch 2611 · Released
Reviewed by exception and e-signed by the QA head in 1 day. Paper review used to take 6.
On paper
The batch is written down after it happens.
- Weights are read off the balance and written by hand, then checked by a second person who may not have seen the reading.
- Missing signatures and blank fields are found days later, at QA review, when the operator has moved on.
- Deviations are written up after the shift, from memory, with the context scattered across logbooks.
- QA reads every page of every record, and release waits a week.
Electronic batch record
The batch is recorded as it happens, and checked before QA sees it.
- Weights come straight from connected balances with tolerance checked against the master recipe.
- Steps will not move forward until mandatory fields and second-person verifications are complete.
- Deviations are raised from the step at the moment a limit is crossed, with the context attached.
- The AI Batch Reviewer checks every entry so QA reviews only the exceptions and releases in a day.
AI reads every entry. QA makes every decision.
Before a record reaches the QA desk, the AI Batch Reviewer checks it against the effective master: completeness, verifications, limits, deviations and correction patterns. QA gets a short list of what needs a human.
- Sent back · completed 11:04
Step 31 · Sifting
Second-person verification missing
- Sent back · completed 11:09
Step 48 · IPC 10:30
Verifier signature missing on weight check
- No action
All in-process values
Hardness, weight, thickness, friability within limits
- Closed with justification
DEV-2026-0381
Drying time +6 min · impact assessed
- No unusual pattern
Corrections
3 corrections, each with reason and signature
- Awaiting QA head
Decision
Ready for QA review by exception
The AI never approves or releases a batch.
Release stays with authorised QA personnel, signed electronically with name, time and meaning.
Every highlight is explainable
Each flag points to the exact step, field, value and rule it was checked against, so the reviewer can confirm it in one click.
How the review worksBuilt on ALCOA, so the record holds up in an audit.
Every entry in a batch record carries who made it, when, where and why it changed. Nothing is overwritten and nothing is deleted.
Attributable
Every entry is tied to a unique user. No shared logins on the shop floor.
Legible
Structured values with units. No handwriting to interpret years later.
Contemporaneous
Entries are timestamped by the server when they are made, not when they are typed up.
Original
Balance and machine readings are stored as captured, with the source instrument.
Accurate
Values are checked against limits as they are entered, and corrections need a reason.
Designed for 21 CFR Part 11 and EU Annex 11
Validation for regulated use is carried out with your team, under your quality system.
One batch record discipline, six kinds of plant.
Pharmaceutical formulations
Tablets, capsules, liquids and injectables, with in-process checks captured on schedule and release by exception.
Ayurvedic manufacturers
Classical and proprietary preparations, multi-stage processing of herbs, and records aligned with your GMP schedule.
Nutraceutical plants
Vitamin, protein and herbal supplement batches, with label claims tied to the master recipe.
Cosmetic manufacturers
Creams, lotions and serums, with phase-wise mixing, temperatures and hold times recorded by step.
Contract manufacturers
Separate masters and records per client, with a signed batch dossier you can share on release.
API intermediate plants
Reaction stages, charging, temperature and yield records, with deviations raised from the step.
Start with one product on one line.
A first production line typically goes live in six to ten weeks. Then you add products, lines and sites on the same workspace.
- Weeks 1-201
Map and convert
We study your current BMR, SOPs and room layout, and convert your first master records into structured recipes.
- Weeks 3-402
Configure and connect
Rooms, equipment, roles and signatures are set up, and balances and scanners are connected on the floor.
- Weeks 5-603
Validate together
We provide validation documentation and support while your QA executes the protocols under your quality system.
- Weeks 7+04
Run and expand
The first batches run electronically with our team on the floor, then more products and lines follow.
What QA heads ask us first.
Does the AI release batches?
No. Only authorised QA people review and release batches. The AI Batch Reviewer checks every entry and highlights gaps, out-of-limit values and open deviations so QA can decide faster.
Is it 21 CFR Part 11 and EU Annex 11 ready?
It is designed around what those rules expect: complete audit trails, unique user access, electronic signatures with meaning, and controlled records. Validation for regulated use is done together with your team under your quality system.
Does it connect to balances and machines?
Yes. Weighing balances connect directly so weights are captured without transcription. Machines with OPC UA or similar interfaces can send parameters into the batch record, and barcode scanners work out of the box.
Can we start with one product line?
Yes, and most plants do. Start with one product on one line, prove it with your QA, then add products, lines and sites on the same workspace.
Does it support Ayurvedic and nutraceutical plants?
Yes. Master recipes handle herbal extracts, multi-stage formulations, classical preparations and label claims, and the same batch record, deviation and release flow applies under your GMP schedule.
How long does implementation take?
A first production line typically goes live in six to ten weeks, covering master record conversion, balance connection, user training and validation support. Timelines depend on the number of products and your validation approach.
Your next batch could leave the cleanroom like 2611.
Tell us about your products and lines. We will walk your QA and production heads through one of your own batch records, step by step.
- Record
- Your plant · first production line
- Meaning
- Approved for a live walkthrough
- Signed by
- You, in under two minutes