Drug discovery shouldn't be the only place for AI in life sciences.

Look closer: AI can make your operational teams nimble and efficient.

LLMs excel at writing documents—the bulk of work in Quality and Computer System Validation (CSV). GxPChat connects your teams with specialized AI agents (SOP drafting, Audit, CSV, IT Help Desk, Regulatory Asset Management) via secure MCP servers, strictly adhering to 21 CFR Part 11.

Explore platform architecture, MCP tool schemas, and validation guides on the documentation site at docs.gxpchat.com →

Live Demonstrations & System Previews

GxP Suite Explorer: Enterprise QMS & System of Record

21 CFR Part 11

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Life Sciences QMS & CSV System of Record • 3-Database division of labor (PostgreSQL SoR, Qdrant Vector, Memgraph LPG) with zero-trust EvidenceGate verification and real-time immutable audit trail stream.

Dedicated Page → Direct PNG →

Live Demo: Overview & Validation Session

21 CFR Part 11

End-to-end walkthrough of GxPChat connected to regulated MCP servers.

Dedicated Page → Direct MP4 →

Live Demo: QMS Dashboard & System of Record

QMS Portal

Live walkthrough of the Life Sciences QMS dashboard, agent telemetry, compliance graph explorer, and audit trail system of record.

View Screenshot → Dedicated Page → Direct MOV →

Agent Workflow: Submit IT Ticket

ITSM Agent

Automated IT Help Desk ticketing and access request workflow via secure MCP tools.

View Screenshot → Dedicated Page → Direct MP4 →

Agent Workflow: Add Regulated Asset

Asset Management

Regulated asset registration and validation tracking with audit trail compliance.

View Screenshot → Dedicated Page → Direct MP4 →

Platform Showcase: CSV / CSA Validation Governance

ISPE GAMP 5 & CSA

CSV / CSA Validation Governance Platform

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Continuous algorithmic verification across life sciences computerized systems: V-Model traceability matrix (RTM), automated test script execution status (298 Pass, 154 Fail), GAMP 5 software categorization (Cat 3, 4, 5), and automated Validation Summary Report (VSR) generation.

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Platform Showcase: GxP Backup & Disaster Recovery Console

21 CFR § 11.10(c)

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SOP-IT-018 & SOP-IT-019 Enterprise Governance: Automated AES-256 cloud snapshots with continuous WAL replication, qualified benchtop manual backup protocols, periodic sandbox restoration drills (1.5h achieved RTO / 0.12h achieved RPO), and ALCOA+ enduring data integrity.

View Screenshot → Dedicated Page → Direct PNG →

Contact & Pilot Access

We are actively partnering with innovative biopharma, biotech, and medical device organizations to deploy tailored GxPChat pilot environments.

For custom MCP server integrations, CSV pipeline automation, or live demonstrations:

Documentation: docs.gxpchat.com →

Email: duk@saram.io

Phone: 925 394-6606

Parent Organization: Saram Consulting