Pharma & Life Sciences Manufacturing (GMP)
Every batch, deviation and test result connected: release faster, stay audit-ready.
Batch records, deviations and lab data are scattered; compliance work is slow and manual.
The question it answers
“Which open deviations could delay release of this month's batches?”
What changes: Faster batch release, fewer compliance gaps.
All seven layers
How ForgeOrbis works for pharma.
- 01
Connect
IngestData sources
- ERP
- MES/electronic batch records
- LIMS
- QMS
- Equipment data
- Warehouse
- 02
Understand
ExtractFacts from unstructured data
- Paper/scanned batch records
- Deviation reports
- SOPs
- Audit observations
- 03
Unify
ResolveWhat must be matched
- Materials and lots across ERP and LIMS
- Equipment IDs
- Vendor variants
- 04
Relate
ModelObjects and links (the ontology)
- Product
- Batch
- Material Lot
- Equipment
- Deviation
- CAPA
- Test Result
- SOP
- 05
Decide
AskExample question
“Which open deviations could delay release of this month's batches?”
- 06
Execute
ActApproved actions
- Draft deviation report
- Route for QA review
- Hold lot
- 07
Trust
GovernTrust and compliance
- Data-integrity rules (e.g., 21 CFR Part 11 / EU Annex 11 principles)
- Validated changes
- Full audit
What a pilot measures
Each pilot measures 2 to 3 KPIs you already track, before and after. We publish no benefit numbers until a customer has measured them.
- Batch release cycle time
- Deviation closure time
- Right-first-time %
- Audit findings
Who it is for
- Head of quality
- Site head
Where it stands today
What runs today, and what we are still building.
We would rather tell you up front than discover it in week three. A pilot starts with what runs today.
The platform
- 01ConnectIngestPartly live
- 02UnderstandExtractPartly live
- 03UnifyResolveRoadmap
- 04RelateModelPartly live
- 05DecideAskLive
- 06ExecuteActLive
- 07TrustGovernPartly live
Still to build for pharma
- Enterprise connectorsLayer 1ERP, databases, ticketing, CRM, TMS/WMS, PLM connectors
- Document extractionLayer 2OCR + layout, forms, tables, scanned records, stamps
- Entity resolution (assets/things)Layer 3Vessels, parts, equipment tags, SKUs, sites across systems
- Regulated-data complianceLayer 7Evidence admissibility, financial/health/GMP data rules
Live means shipping in the product today. Partly live means part of the layer ships today and the rest is being built. Roadmap means being built and not available yet. We never show it as available.
Book a pilot
One site, one problem, measured in weeks.
Each pilot measures 2 to 3 KPIs you already track, before and after. We publish no benefit numbers until a customer has measured them.