First
The formula is retyped
Quantities, mesh sizes, RPMs and equipment identifiers get copied by hand from the approved master into a blank record. Batch after batch. Strength after strength.
AI batch record software
Pharma batch records, drafted by AI.
Signed by your QA.
PharmaSynapse prepares the blank batch manufacturing record in your own format, from the master formula you have already approved. It stops at the signature line. Your QA carries it across.
- In one paragraph
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PharmaSynapse is an AI authoring layer for GMP batch documentation. It drafts an issuance-ready batch manufacturing record from an approved master formula, before the batch is run. A qualified person reviews and signs. The software never signs, and it never creates a record.
- 21 CFR Part 11
- 21 CFR 211.188
- EU GMP Annex 11
- EU GMP Chapter 4
- ALCOA+
- GAMP 5
The step nobody automated
A master formula is approved once, then retyped forever.
The tablet batch record on our desk runs to seventy-three pages. Two for dispensing, fourteen for granulation, twenty-four for compression, twenty-two for coating. Almost none of it is new information. It is the approved master, retyped.
Then
Small drifts appear
A decimal. A stale equipment identifier. Last revision's in-process limit. Nothing dramatic, which is exactly the kind of thing an audit finds.
So
Review turns into proofreading
Because any line could have drifted, QA checks all of them. The effort goes into the transcription instead of the science.
21 CFR 211.188 requires the batch record to be an accurate reproduction of the appropriate master production and control record. That reproduction step is the one still being done by hand.
Where this sits
The blank record, not the executed one.
Batch documentation software almost always starts once manufacturing begins. Execution on the floor, in-process capture, deviation handling, review, release. PharmaSynapse works on the step before any of that.
We do not execute batches, capture in-process values, or release them. If you already run an MES, this hands off to it. If you do not, and plenty of manufacturers between twenty and five hundred people do not, nothing here assumes one.
What comes out
A document your reviewer already knows how to read.
Not a chat transcript. Not a PDF export of a table. A batch record in your own format, watermarked Draft, with every value traceable back to the master it came from.
State is stamped in the file
The watermark, the header banner and the footer travel with the document. A printed page cannot be mistaken for an approved record.
Every value names its source
The master formula reference and its revision print on the record, so any figure traces back in one step.
Signature blocks stay empty
Nothing is pre-signed and nothing is auto-approved. It becomes a record when a qualified person signs it.
What it does not do yet, said inside the product
The boundary
A draft is not a record.
The distinction is the whole product. One is machine output you can throw away without consequence. The other is a controlled GMP document with a person's name bound to it.
Nothing crosses that gate on its own. There is no configuration that lets it, and there is no plan to build one.
Who built this
Twelve years writing these records. Ten years building systems that read them.
"I spent twelve years preparing and reviewing these documents. The software I wanted did not exist, so we built the one that stops exactly where a person has to take over."
Kinjal Patel · Co-founder and CEO
- 12 years pharmaceutical QA
- QMS and validation
- Qualification and vendor management
- IPQC
- Oral solids and injectables
"Most of the engineering went into what the system refuses to do. Every one of those refusals was the harder build."
Mitesh Patel · Co-founder and CTO
- 10 years AI engineering
- Retrieval-augmented generation
- Document AI
- Healthcare AI
- Regulated-data environments
- Deterministic architectures
Before you take this to your QA head
Three questions we always get
Q1
Can AI write a batch manufacturing record?
It can write the draft, and that is the accurate way to put it. PharmaSynapse composes an issuance-ready record from your approved master formula and your master data. At that point it is machine output, not a record. It becomes a record when a qualified person reviews it and signs, and nothing in the system will do that step.
Q2
Does the AI sign the record?
No, and the architecture does not allow it. Every review, approval and submission needs a person to re-authenticate, and the submission carries that person's authorship e-signature. There is no automatic approval path and no configuration that creates one.
Q3
Is AI allowed in GMP documentation?
A draft Annex 22 to EU GMP covering artificial intelligence has been published for consultation and is not yet in force. It separates systems that support a decision from systems that make one, and it expects a qualified person to stay accountable for the output. PharmaSynapse is built for the first category. It drafts. A person decides.
Early access
We are letting a small number of manufacturers in early.
PharmaSynapse is not generally available. We are working with a short list of commercial manufacturers to prove the draft against real master formulae before this goes wider. Tell us where you sit and one of us will come back to you.