Pharma and Life Sciences

FDA 21 CFR Part 11 Compliant Automation

FrameworX delivers validated solutions for pharmaceutical 
manufacturing with complete audit trails and electronic signatures.

Key Capabilities

  •  FDA 21 CFR Part 11 compliance features
  • Electronic signatures and audit trails
  • Clean room environmental monitoring
  • Validated system templates

Common Applications

  • Clean room monitoring
  • Batch manufacturing
  • Equipment validation
  • Laboratory systems
  • Clinical trial data
  • Cold chain monitoring

Worked example

Local AI Ontology Demo — the canonical pharma solution shipping with FrameworX 10.1.5. A wet-granulation Cell A with Mixer M-101 and Reactor R-101, modeled to ISA-88 (Enterprise → Site → Area → ProcessCell → Unit → EquipmentModule) with a live Batch B-001 executing two operations.

The ISA-88 ontology is imported in one click from a small RDF/OWL file; the UNS materializes 8 typed UDTs and 20 tags following the dual-shape pattern (3 /Attr envelopes carrying static ontology metadata on the Enterprise and two Areas + 10 naked UserType instances carrying live equipment data on the Site, ProcessCell, Units, EquipmentModules, Batch, and Operations + 6 runtime helpers + 1 built-in scaffold). Operator displays drill from Plant Overview through the Cell A schematic into individual unit detail; a Local AI chat panel answers plain-language questions grounded in live tag values, alarm state, and the active batch context. A server-side anomaly monitor calls Local AI for a two-sentence narrative whenever the Mixer's anomaly score crosses threshold — the narrative pins to the alarm and the trend chart, so a shift handover three hours later still sees what happened and why.

The two-paradigm pattern

FrameworX combines static ontology metadata (via /Attr envelopes carrying literals with StartValue defined) with live equipment data (via naked UserType instances with dynamic members fed by Devices, Scripts, or simulators). The pharma and life-sciences industries are the canonical use case — ISA-88 batch hierarchy as static ontology metadata, batch-by-batch operational data on naked equipment instances. See Industrial Ontology Integration How-to → Two paradigms for the full pattern.

The pattern generalizes to any batch process: bring your reference ontology (ISA-88, ISA-95, an OEM template, your corporate asset model), import it, layer operational members on top in Designer, and the chat, anomaly narrative, and drill-down displays work against any UDT that exposes the same members.

Use Cases

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