Pharmaceutical & Life Science Industry
Quality and Compliance That Hold Up to an Audit
Batch and lot traceability, GMP-aligned quality workflows, and audit-ready records, configured natively on Microsoft Dynamics 365 F&O around your specific production and regulatory requirements — not a rigid template stretched to fit.
BUILT ON DYNAMICS 365 F&O
Configured to your quality system, not the other way around
Pharmaceutical manufacturers can’t fit their quality and validation requirements into a generic manufacturing product. CEM configures D365 F&O natively to meet your specific GMP, batch record, and traceability requirements, rather than layering a rigid third-party product on top.
Native D365 F&O, not a bolt-on
No third-party layer to license, patch, or outgrow — your solution stays inside Microsoft's core platform and roadmap.
Built Around Your Process
Batch records, deviation management, and quality workflows structured to match your existing SOPs, not a generic template.
Scales as You Do
Add product lines, sites, or regulatory markets without re-platforming or re-validating from scratch.
The Four Pillars of Pharmaceutical Manufacturing success
Full Batch & Lot Genealogy
Trace every batch from raw material through finished product and distribution — the traceability a recall or audit demands.
GMP Aligned Quality Workflows
Deviation management, CAPA, and in-process quality checks configured to match your existing quality management system.
Audit-ready Electronic Records
Electronic batch records and documentation structured for inspection readiness, not assembled under deadline pressure.
Expiration & Storage Condition Control
Track expiration dates and storage requirements automatically across inventory, so nothing ships or gets used out of spec.
The Four Pillars of Pharmaceutical Manufacturing success​
Trace every batch from raw material through finished product and distribution — the traceability a recall or audit demands.
Deviation management, CAPA, and in-process quality checks configured to match your existing quality management system.
Electronic batch records and documentation structured for inspection readiness, not assembled under deadline pressure.
Track expiration dates and storage requirements automatically across inventory, so nothing ships or gets used out of spec.
KEY BENEFITS
Batch & Lot Traceability
Full forward and backward genealogy from raw material and supplier lot through finished product and shipment.
Electronic Batch Records
Structured, audit-ready batch documentation configured around your existing SOPs and quality processes.
Expiration & Storage Tracking
Automated tracking of expiration dates and required storage conditions across every lot and location.
Quality & Deviation Management
Document non-conformances, deviations, and corrective actions to the standard your quality system and regulators expect.
Copilot-Enabled Reporting
Microsoft Copilot and AI are built directly into D365, giving CEOs real-time visibility into production, costs, risks, and performance to make faster, smarter business decisions.
Multi-site, Multi-market Consolidation
Roll up production, quality, and financial data across every facility and regulatory market in one view.
Trusted by Pharmaceutical & Life Science Manufacturers
Frequently asked questions
Yes. Deviation management, corrective and preventive action (CAPA) workflows, and in-process quality checks are configured within D365 F&O to align with your existing GMP quality management system, rather than requiring a separate quality module.
Every batch is tracked with full forward and backward genealogy — from raw material and supplier lot through finished product and distribution — supporting recall response and regulatory audits.
Yes. Electronic batch records are structured within the platform to match your existing standard operating procedures, supporting inspection readiness rather than requiring records to be assembled manually under deadline pressure.
Yes. Expiration dates and required storage conditions are tracked across every lot and location, reducing the risk of out-of-spec product being shipped or used.
Timelines depend on company size, number of sites, and regulatory complexity. CEM has completed 350+ Dynamics 365 implementations across manufacturing and construction in 19 countries; your specific timeline is scoped during a discovery call.
Ready to bring quality and traceability into one system?
See how CEM configures Dynamics 365 F&O around your quality system and regulatory requirements.
