Safety and quality records, ready for the inspector
A private AI workspace, built for your company and carrying your brand. It drafts deviations, CAPA and change control from your batch records and SOPs, and holds each one for QA approval.
- In review
DEV-0412
Deviation: granulation temperature
Batch B-2291 · QA review
- Draft ready
CAPA-118
CAPA from OOS investigation
Drafted from BMR and SOP
- Waiting
MOC-037
Change of solvent supplier
HAZOP node 4 revalidation
- Approved
PESO-09
Storage licence renewal pack
Approved by plant head
Batch records and deviations
- 1Batch record and SOPs read
- 2Deviation drafted with the evidence
- 3Investigation and CAPA proposed
- 4QA review
- QA head approves release
Nothing is released without QA approval.
From batch record to licence renewal, audit-ready
Batch records and deviations
Draft deviation reports, investigations and CAPA from batch records and SOPs, for QA approval.
HAZOP and MOC documentation
Draft MOC records, track HAZOP actions and flag revalidation triggers after a process change.
Regulatory dossiers and licence renewals
Assemble PESO licence packs, consents to operate and CDSCO submissions before they fall due.
SOP and change control
Keep SOPs current and show every document a change affects, so nothing is updated in one place only.
COA and customer documentation
Link certificates of analysis, SDS and customer declarations to the batch and shipment they belong to.
Written for QA, process safety and the inspector
The workspace follows your SOPs and your QA release chain. Drafts cite the batch record, SOP or P&ID they came from, and each change is attributed to a named account.
- BMR / BPR
- Deviation
- OOS / OOT
- CAPA
- Change control
- QA release
- SOP
- HAZOP node
- MOC
- PSSR
- P&ID
- SDS
- Consent to operate
- Audit-ready
Granulation temperature excursion
- Event descriptionBMR B-2291, step 14Drafted
- Process parameter limitsSOP-PR-022 §5Cited
- Impact on product qualityStability dataQA check
- Root cause and CAPAInvestigationOpen
Approvals
- ProductionApproved
- QAQA reviewerReviewing
- QHQA headNext
- 01Draft prepared from BMR and SOP
- 02Production approved
- 03Waiting on QA reviewer
Built to support the evidence you need for Schedule M and 21 CFR Part 11
GMP and process safety obligations stay with your team. The workspace keeps who did what, when and from which source, in line with the data integrity your auditors look for.
On record for every item
- The source document, page or clause behind every line
- Who prepared it, who approved it and when
- Role-based access: people see what their role allows
- Named accounts only, each person signs in as themselves
Pharma and GMP
- Revised Schedule M
- CDSCO
- WHO-GMP
- 21 CFR Part 11
- EU Annex 11
- ALCOA+
- ICH Q9 / Q10
Process safety
- PESO
- OISD standards
- MSIHC Rules
- Factories Act
Environment and chemicals
- CPCB / SPCB consents
- REACH
- ISO 14001
- ISO 45001
Listed as the frameworks this work runs under. Inference does not certify compliance; your teams and auditors do.
One workflow first, then the next
There is no signup form. Every workspace starts with a conversation and the one workflow that hurts most.
01 · Discovery
Discovery conversation
We talk through how the work moves today, who does it and where it gets stuck, then agree on the one workflow worth starting with. Implementation is quoted after this conversation.
02 · Build
Your workspace, built with your people
We set up a private workspace in your name, import the files that matter and shape the workflow with the people who do the work. Facts are reviewed before the workspace relies on them.
03 · Running
Running with approvals
The workflow runs on real work. A named person approves every consequential step, and every action is logged: who asked, what was prepared, who approved it.
04 · Expand
Next workflow
Once the first workflow is part of the week, we scope the next one. Each builds on the same documents, approvals and audit trail.
After setup: one fixed monthly fee and one invoice, covering hosting, fixes, security and upkeep. New workflows and integrations are scoped separately.
Works with the quality and plant systems you already run
No rip-and-replace. We connect the systems your first workflow needs, scoped during discovery, and the workspace is not tied to one AI provider.