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Regulatory Compliance and Data Management in Dynamics 365: What Life Sciences Teams Need to Get Right

  • Carina Gregersen
  • Dec 1
  • 3 min read
Illustration of a person working on a laptop with charts, graphs, and data icons above them, representing compliance and clean data management in Dynamics 365.

Why Compliance in Dynamics 365 Is a Life Science Priority

In 2024, global regulatory fines topped $19.3 billion. While those penalties weren’t all tied to Microsoft Dynamics 365, the lesson is clear — if your ERP data isn’t secured and managed in line with industry rules, you’re exposed.


For Life Science companies, compliance isn’t just about avoiding penalties. It’s about protecting product integrity, ensuring patient safety, and maintaining the trust of regulators, partners, and customers.


And because your ERP — in this case, Dynamics 365 Finance & Supply Chain — is where your critical financial, operational, and quality data lives, your compliance strategy starts there.


The challenge? Microsoft gives you powerful security tools, but they don’t configure themselves. If you’re in pharma, biotech, or medical devices, you need a compliance framework that’s purpose-built for your industry, not just the platform.


Key Regulations Impacting Your ERP Data

Life Science businesses face both broad data protection laws and industry-specific compliance requirements. A few that commonly shape Dynamics 365 setups:


Data Protection

  • GDPR – European regulation protecting personal data privacy

  • CCPA – California law similar to GDPR, focused on consumer data

  • ISO/IEC 27001 – Global standard for information security management systems


Financial Integrity

  • SOX (Sarbanes-Oxley Act) – U.S. law requiring internal controls, reporting accuracy, and regular audits

  • PCI DSS – Standards for protecting payment card data


Healthcare-Specific

  • HIPAA – U.S. law safeguarding patient health information

  • HITECH – Promotes secure adoption of electronic health records


Public Sector Compliance

  • FedRAMP – Federal cloud security standards

  • CJIS – FBI policy for criminal justice information security


The takeaway? You can’t just “turn on” Dynamics 365 and assume you’re covered — your setup must be mapped against the regulations that apply to you.


The Compliance Features You Need to Configure (Not Just Turn On)

Microsoft Dynamics 365 offers a suite of security and compliance tools, but many require active configuration — and in some cases, supplemental solutions — to meet life sciences standards.


Role-Based Security

  • Assign access by job function (duties, privileges, permissions)

  • Review regularly to avoid “access creep” and segregation-of-duties (SoD) conflicts


Authentication & Access Controls

  • Integrate with Microsoft Entra (Azure AD)

  • Enforce Multi-Factor Authentication for sensitive transactions


Audit Logging & Monitoring

  • Enable database logging for sensitive changes

  • Use enhanced logging solutions if you need deeper traceability


Data Protection Policies

  • Configure encryption for data at rest and in transit

  • Apply Data Loss Prevention (DLP) rules to prevent unauthorized exports

  • Implement retention policies that match your regulatory timelines


Sensitive Data Controls

  • Define what’s “sensitive” in your context — lab results, batch records, patient identifiers — and control who sees it

  • Mask or anonymize when needed for training or limited access


Building a Compliance Framework That Actually Works

We recommend a seven-step approach for Life Science organizations:


  1. Risk Assessment – Identify the most sensitive data in your ERP and where it’s at risk.

  2. Map Regulations to Features – Link each compliance requirement to a specific Dynamics 365 capability or add-on.

  3. Design Security Architecture – Define roles, permissions, and segregation-of-duties rules.

  4. Configure Controls – Set up logging, DLP, encryption, and retention policies.

  5. Monitor Continuously – Use dashboards and alerts to catch issues early.

  6. Test & Validate – Simulate audits, breaches, and data requests to ensure readiness.

  7. Document & Train – Keep clear records and educate your team on compliance best practices.


Measuring, Monitoring, and Improving Compliance Over Time

Compliance isn’t a “set it and forget it” project. You need clear metrics and a loop for continuous improvement.


KPIs to Track:

  • User access review completion rate

  • Audit log coverage for critical data entities

  • Number of SoD conflicts detected

  • Policy violation count and resolution time

  • Compliance training completion rate


Best Practices for Ongoing Readiness:

  • Schedule quarterly internal audits and annual third-party reviews

  • Monitor Microsoft’s Dynamics 365 release notes for features that affect compliance

  • Keep a documented change control process with compliance checks baked in


The Bottom Line

For Life Science companies, Dynamics 365 compliance is about more than avoiding fines — it’s about ensuring every batch, every shipment, and every patient record meets the highest standards of accuracy, security, and traceability.


Maggnumite for Life Science helps regulated manufacturers configure Dynamics 365 so compliance and data integrity are built in — not bolted on.

That means:

  • Faster, more accurate audits

  • Reduced risk of SoD conflicts

  • Confidence that your ERP is aligned with both industry rules and company policies


📅 Contact info@maggnumite.com to see how we can make your Dynamics 365 environment a compliance asset, not a liability.

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