Cegeka Pharma & Life Sciences is an industry-specific solution for pharmaceutical, life sciences, and medical device companies built on Microsoft Dynamics 365 Supply Chain Management. Developed for highly regulated environments, the solution helps organizations meet industry standards, government regulations, and global regulatory requirements, including those from the FDA and EMA.
The solution provides capabilities for regulatory compliance, inventory and material management, lot traceability, production control, and quality management. It enables companies to monitor inventory levels, establish material requirements for production, control material usage, and support procurement and replenishment processes.
Full lot traceability supports monitoring the lifecycle of batches and materials from raw material receipt through delivery of finished products. Production management capabilities help manufacturers manage formulation and pre-formulation activities, execute production-related tasks via mobile devices, and support compliance with cGMP requirements.
Quality management functionality includes quality control testing, result tracking, corrective actions, configurable approval workflows, electronic signatures compliant with 21 CFR Part 11, and a fully embedded audit trail. The solution also supports a risk-based validation approach aligned with GAMP5, 21 CFR Part 820, EudraLex Volume 4 Annex 11, and Annex 15.
By combining Microsoft Dynamics 365 Supply Chain Management with industry-specific functionality, Cegeka Pharma & Life Sciences addresses the operational, quality, traceability, and compliance requirements of pharmaceutical, life sciences, and medical device organizations.
