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Pharma Labelling & GS1 Compliance Applications

Three integrated applications enable end-to-end labelling governance with SOP management, GS1 barcode validation, and AI-driven compliance-built with GxP audit trails and 21 CFR Part 11 compliance.

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Our Pharma Labelling & GS1 Compliance Applications

Labelling SOP & Procedure Management

Replace fragmented Word documents with a governed, version-controlled, GxP-auditable SOP platform – centralizing labelling procedures across all sites, teams, and functions organization-wide.

Barcode GS1 Compliance Validator

Scan and validate every barcode against GS1 requirements before batch dispatch – with GTIN, SSCC, GLN, and Digital Link verification across all pack levels, and structured exception reporting on every failure.

Capabilities

Regulatory Data Standards

Barcode GS1 Validator and Regulatory AI Agents both enforce GS1 and regulatory requirements and EMA ePI Implementation. Guide compliance rules built into validation logic.

AI Agents

Regulatory AI Agents are purpose-built pharma AI agents – classification, label analysis, and compliance gap detection deployed on Azure AI Services with pharma regulatory domain context.

Azure AI Services

Underlying AI platform for Regulatory AI Agents – Azure-native, GxP-compatible, and integrated with the broader Azure Health Data Services and FHIR ePI architecture.

Azure Native Development

All three applications are built on Azure – Azure App Services, Azure AI Services, and Azure Health Data Services – within Deevita’s Microsoft partnership framework for regulated health tech.

Pharma Labelling Compliance Built for Regulated Environments

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Benefits

  • All labelling SOPs in one governed platform – version-controlled and GxP-auditable
  • Role-based access across all sites and teams – one source of truth, no fragmented documents
  • 21 CFR Part 11 built-in – audit trail on every SOP change, review, and approval
  • Approval workflows are enforced before any change goes live – no unauthorised updates in a regulated environment

Why Deevita

  • Regulated environment expertise – GxP and 21 CFR Part 11 built in from day one, not retrofitted
  • Pharma domain depth – AI built with regulatory context, not a generic LLM on labels
  • Azure-native – scalable, secure, and compatible with your existing Microsoft infrastructure
  • Real World Implementation – all two applications proven in a pharma -regulated environment at a global pharma manufacturer
  • Integrated programme – SOP management, barcode validation, and AI compliance intelligence built to work together, not as separate tools

Our Pharma Labelling & GS1 Compliance Solutions

Digital Label SOP Platform

Centralized, version-controlled, GxP-auditable SOP library – with approval workflows, role-based access, and full audit trail

Regulatory AI Agents

AI-powered label classification, compliance gap detection, and label change analysis – with Human-in-the-Loop governance and 21 CFR Part 11 audit trail on every action

Pharma Labelling & GS1 Compliance Applicable Use Cases

Standardizing Labelling Procedures Across Global Manufacturing Sites

Life Sciences – Pharma Manufacturer

Change
Problem

A pharma manufacturer across multiple sites manages labelling SOPs in Word documents on site-specific shared drives – no version control, no approval workflows, no way to confirm which version is active at any site. A GxP inspection raised this as an observation requiring remediation.

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Solution

Deevita deploys the Digital Label SOP Platform – centralizing all labelling SOPs in a governed environment with version control, approval workflows, role-based access, and a GxP-compliant audit trail. Every site accesses the current approved version. Inspection-ready at any time.

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Impact
  • All labelling SOPs centralized – active version confirmed and accessible at every site
  • Approval workflows replace email chains – every change tracked and approved before activation
  • GxP audit trail delivered inspection-ready – complete version history available without manual assembly
  • GxP inspection observation closed – remediation evidenced and documented within the platform
Preventing GS1 Barcode Non-Conformances Before Batch Dispatch

Life Sciences – Global Pharma Manufacturer

Change
Problem

A pharma manufacturer discovered GS1 non-conformances in a dispatched batch – incorrect application identifiers and missing GTIN check digits not caught during production. Recall and remediation cost significantly more than prevention.

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Solution

Deploy the Barcode GS1 Validator for batch-level validation before every dispatch – checking GTINs, application identifiers, and EU FMD serialisation elements, with structured exception reports and remediation guidance on every failure.

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Impact
  • Every batch is validated before dispatch – non-conformances are caught before leaving the facility
  • Structured exception reports with reason codes and remediation guidance – every failure actionable, not just logged
  • Recall risk is eliminated at the point of dispatch – not discovered after delivery
Label Management Solution

Life Sciences – Global Pharma Manufacturer

Change
Problem

A global pharma manufacturer managing a large multi-market label portfolio faces significant manual regulatory effort extracting, structuring, and validating label data across legacy formats – with no audit trail on AI-assisted actions and no governed process for AI use in a regulated context. Regulatory teams need AI assistance that reduces effort without sacrificing compliance governance.

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Solution

Deevita architects an AI-assisted label management solution combining intelligent label data extraction, structured output generation, and a Human-in-the-Loop governance layer – with a 21 CFR Part 11-aware audit trail on every AI action, delivered in a pharma-regulated production environment.

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Impact
  • AI-assisted label extraction significantly reduces manual regulatory effort – structured output generated from existing label formats across all markets
  • Human-in-the-Loop governance is enforced at every step – no AI output enters a regulated workflow without human review and approval
  • 21 CFR Part 11-aware audit trail on every AI action – full traceability across extraction, classification, and validation built into the architecture
  • Regulatory teams focus on review and decision – not manual data extraction and formatting
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