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power-platform 2023

Regulatory Approval Automation

Global Pharmaceutical Company | Health / Pharmaceutical

A compliance-critical workflow system for approving promotional and medical materials.

Regulatory Approval Automation
Regulatory compliance assured (INFARMED/EMA)
Complete version traceability
Approval cycle halved
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The Challenge

Promotional material approval ran on email and shared folders, making it slow, opaque and difficult to audit.

The Solution

A Dataverse-backed approval engine orchestrated by Power Automate, with an immutable audit trail and automatic document watermarking.

📋 Overview

In a heavily regulated sector, a global pharmaceutical company needed every marketing and medical material to pass a rigorous validation process before release. The solution digitised a complex approval flow spanning Medical, Legal, Compliance and Marketing.

🎯 The Challenge

Business context Promotional material approval was managed through email and shared folders. Using an outdated or unapproved version of a document was a critical risk that could result in heavy fines. The process was slow, opaque and hard to audit, which frustrated marketing teams who needed to move quickly.

Technical requirements

  • Sequential and parallel routing: different material types require different approver paths.
  • Immutable audit trail: a record of who approved what and when, that cannot be altered.
  • Brand and legal checks: mandatory checklists at every stage.
  • Records retention: documents kept for statutory periods of five years or more.

💡 The Solution

Strategic approach Microsoft Dataverse as the secure relational store behind the process, with Power Automate running the document state machine. This gives the robustness an audit demands, beyond what SharePoint lists can offer for compliance-critical scenarios.

Technical implementation The Regulatory Approval App handles material upload and metadata.

  • Rules engine: the system determines the required approvers automatically from therapeutic class and media type.
  • Watermarking: DRAFT or APPROVED stamps are applied to PDFs automatically.
  • Adobe PDF Services integration: secure in-app viewing and annotation, with no download to local desktops.

Timeline

  • Phase 1 (regulatory analysis): 3 weeks
  • Phase 2 (core development): 5 weeks
  • Phase 3 (validation and UAT): 4 weeks
  • Phase 4 (deployment): 2 weeks

📈 The Results

Success metrics

  • 🛡️ Risk: zero non-conformities in external audits after implementation.
  • ⚡ Time to market: campaign materials approved in half the time.
  • 🔍 Visibility: marketing can see exactly whose desk a process is sitting on.

Business impact The tool turned Compliance from a blocker into an agile partner, protecting the company legally without throttling commercial activity.

🛠️ Technology Stack

  • Dataverse: robust, secure data platform.
  • Power Automate: orchestration of complex approvals.
  • Power Apps (model-driven): a data- and process-focused interface for auditors.

💬 Client Testimonial

“We sleep a lot better knowing it is impossible for a material to reach the market without every mandatory sign-off. The system has armoured our risk.”

Head of Quality & Compliance Pharmaceutical Company

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Project Details

Client

Global Pharmaceutical Company

Industry

Health / Pharmaceutical

Year

2023

Technologies
Power Automate Power Apps Dataverse Compliance