veeva-qms

Proactively avoid risks with Internal AI Agent for Guided Compliance
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App Type:

Others

App Name:

Veeva QMS

Whatfix Product:

Web

Overview

Goal: Proactively avoid risks with Internal AI Agent for Guided Compliance

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The Problem

Pre state: Quality and Compliance teams identify contamination or other issues (e.g., incomplete sterilization logs, missing attachments) in supplier shipments, leading to external supplier inspections. QA specialists lack contextual guidance at the point of need, resulting in variability in how inspections are conducted and recorded. Documentation errors or skipped steps create inconsistency across suppliers, adding rework and delays.

Business implications: Delays in getting resolutions, affecting time-to-market for new drugs and devices. Increased likelihood of GxP compliance gaps, with higher audit readiness challenges.

Business Process

Quality Management

The Whatfix Solutions

SOP compliance: Whatfix Guidance Agent understands users’ context and offers a guided DAP flow for compliant inspection creation.

Process intelligence: Uses on-screen context, like contamination or incomplete sterilization logs, to infer a compliance gap and activate a compliance within the internal AI agent.

Automation: Triggers initiate an action, instigating a business change, followed by a guided flow to create a quality deviation.

Personas Impacted

Quality Assurance (QA) specialist

Value on Investment

Value Proposition

Whatfix empowers organizations to significantly reduce the time required to complete GxP records, leading to an increased right-first-time submission rate. By eliminating data entry errors, Whatfix ensures accuracy and compliance, ultimately streamlining critical processes and enhancing overall operational efficiency.

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