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AGENTIC PROCESS, PRIMITIVE 02

RPA Agent

Autonomous workflow automation that embeds compliance logic into every GxP process, from deviation reporting to CAPA closure, with 70-80% workload reduction

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Detect
Analyze
Execute
Close
RPA Agent
Just now
Major

Quality event detected, initiating automated deviation workflow

Conversational interface | Multi-platform (Teams, Web, Mobile) | Voice-enabled

Detectβ€ΊEvent Detection
Johnson & JohnsonAstraZenecaNestlΓ©SCA PharmaRhythm PharmaAVEVAVeevaIBMHylandGalvani BioelectronicsOmniscient NeurotechnologymeshMDVeloxisAllovirBattelleFulcrum TherapeuticsNovartisIdorsiaKnipperOrganaBioRomarkWindtree TherapeuticsClene NanomedicineBio-Rad
1

Observe: Conversational Event Capture

Users describe quality events via chat or voice on Teams, Web, or mobile. RPA Agent auto-populates deviation forms using role-aware templates linked to SOPs and master data.

Capturing quality events conversationally

Natural language understanding for deviation reporting, change controls, and logbook entries across multiple platforms.

β€œ

60% faster deviation and CAPA resolution. Zero manual process documentation errors. The RPA Agent handles compliance while we focus on quality.

2

Reason: Intelligent Workflow Orchestration

Agents determine impact level (GMP-critical or routine), identify linked SOPs, impacted assets, and approvers. Routes requests through predefined workflows including quality, validation, and regulatory stakeholders.

Automating deviation & CAPA workflow

AI-driven lifecycle management of quality events with role-based governance, multi-level approvals, and automatic documentation.

β€œ

The parallel processing capability is remarkable. What used to require 5 people now runs autonomously.

3

Act: Autonomous Process Execution

Executes tasks across enterprise systems (SAP, Veeva, ServiceNow) with self-documenting capabilities including timestamps, screenshots, and e-signatures at every step.

Executing across enterprise systems

Seamless connectivity to QMS, EMS, MES, and EDMS with real-time data synchronization and API-driven extensibility.

β€œ

90% time saved on process documentation. Near-instant audit trail access transformed our compliance operations.

Intelligent By
Core Design

Advanced cognitive capabilities with deep regulatory knowledge for autonomous compliance.

Chat Interface
Report a temperature excursion in Building A, Room 302
I'll create a deviation record. Severity: Major. Initiating CAPA workflow...
Quality event DEV-2024-047 created

Conversational Intelligence

Chat or voice-based interaction for initiating quality events with natural language understanding across Teams, Web, and Mobile.

Audit Trail
10:42:03
Record created
10:42:05
User verified
10:42:08
Signature captured
10:42:12
Audit trail sealed
21 CFR Part 11
Electronic signatures
Audit trail
Access controls
Data integrity

Compliance-First Design

Built-in 21 CFR Part 11 and Annex 11 compliance with automatic audit trail generation, role-based access control, and digital signatures.

Workflow Pipeline
Form Auto-Fill
Route Approval
E-Signature
Submit to QMS
Processing Time
2.4s
avg per form
847
Forms today
100%
Accuracy

Real-Time Process Automation

Auto-populates forms, routes workflows, captures signatures, and submits to enterprise systems in real-time with zero manual intervention.

Enterprise Systems
Connected
SAP
Live
Veeva
Live
Service​Now
Live
Werum
Live
Labware
Live
PI
Live
API Endpoints24 active

Enterprise Integration

Seamless connectivity to SAP, Veeva, ServiceNow, Werum, Labware, and PI with API-driven architecture.

Key Performance
Metrics

70-80%
Workload Reduction
Compliance automation
60%
Faster CAPA
Resolution in days, not weeks
Zero
Manual Errors
Full audit trail generation