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.

  1. 01

    Connect

    Ingest

    Data sources

    • ERP
    • MES/electronic batch records
    • LIMS
    • QMS
    • Equipment data
    • Warehouse
  2. 02

    Understand

    Extract

    Facts from unstructured data

    • Paper/scanned batch records
    • Deviation reports
    • SOPs
    • Audit observations
  3. 03

    Unify

    Resolve

    What must be matched

    • Materials and lots across ERP and LIMS
    • Equipment IDs
    • Vendor variants
  4. 04

    Relate

    Model

    Objects and links (the ontology)

    • Product
    • Batch
    • Material Lot
    • Equipment
    • Deviation
    • CAPA
    • Test Result
    • SOP
  5. 05

    Decide

    Ask

    Example question

    “Which open deviations could delay release of this month's batches?”

  6. 06

    Execute

    Act

    Approved actions

    • Draft deviation report
    • Route for QA review
    • Hold lot
    With approval and e-signature
  7. 07

    Trust

    Govern

    Trust 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.