Every batch starts from one approved master.
Author master batch records once, route them through review and approval, and release only the effective version to the shop floor. Every change is controlled, every version is traceable, and no operator ever executes a draft.
Captured in the record
- Material codes, grades and quantities per batch size
- Process parameters with units and limits
- Hold times and sampling points
- Mandatory second-person verification steps
- Required equipment classes per stage
- Signature meaning for every approval
MBR-PCM-500 · Paracetamol 500 mg tablets
Version 7 · Effective- Batch size3,00,000 tablets
- Bill of materials14 materials · locked
- Process steps62 steps · 9 stages
- In-process limitsHardness 6-9 kp · Weight 600 mg ± 5%
- Change controlCC-0418 · closed
- Version 6Superseded
How it flows
- 1
Author
Production builds the recipe from a template or a previous version.
- 2
Review
QA and technical reviewers comment and sign the review.
- 3
Approve
The QA head approves and sets the effective date.
- 4
Issue
Batches are issued only from the effective version.
What your team works with every day.
Structured recipe builder
Build stages, steps, materials, parameters, limits, holds and signatures as structured data, not as a scanned document. Each field knows its unit, range and who may record it.
Version control
Draft, in review, approved, effective, superseded. Only the effective version can be issued, and a new version never changes batches already in progress.
Approval routing
Route each version to the reviewers your SOP requires. Approvals are captured as electronic signatures with name, date, time and meaning.
Change control link
Every new version references its change control record, so an auditor can trace why the hardness limit changed and who agreed to it.
Side-by-side compare
Compare any two versions field by field. Reviewers see exactly what changed instead of reading forty pages again.
Locked once effective
Effective masters are read-only. Corrections go through a new version, never through an edit to the live record.
About Master Recipes
Can we import our existing paper masters?
Yes. Our team converts your current masters into structured recipes during onboarding, and your QA reviews and approves each one before it goes live.
What happens to running batches when a new version becomes effective?
Running batches stay on the version they were issued from. Only new batches pick up the new version.
Can one recipe support several batch sizes?
Yes. Quantities scale from the approved formula, and you can lock specific batch sizes if your registration requires it.
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