Cegeka Pharma & Life Sciences

Cegeka Pharma & Life Sciences is an extended solution specifically developed for the pharmaceutical, life sciences and medical device industry on top of Microsoft Dynamics 365 Supply Chain Management. The purpose of the solution is to meet the specific requirements of the highly regulated industry while endorsing the most advanced technology powered by Microsoft.

The benefits of Cegeka Pharma & Life Sciences include, but are not limited to:

• Regulatory compliance > The solution is designed according to the unique needs of the pharmaceutical and life sciences sector. It enables organizations to enhance their business model to meet industry standards, government regulations and global regulatory requirements promulgated by international agencies such as the US Food and Drug Administration (FDA) and European Medicines Agency (EMA). The approach and methodology developed by Cegeka also help companies streamline Computer System Validation (CSV) activities in compliance with GAMP5 risk-based approach for GxP computerized systems, 21 CFR Part 11, 21 CFR Part 820 and EudraLex Volume 4 Annex 11 and Annex 15.
• Inventory and material management > The capabilities of the solution enable pharmaceutical companies to reduce the waste of material, efficiently monitor the inventory management process and observe inventory levels. The organization can establish material requirements for production, control material usage and set specific goals for procurement and replenishment.
• Lot traceability > Full traceability is available in the ERP system to efficiently monitor the lifecycle of each lot/batch and each individual container/drum/package/box/etc. of material from vendor receipt of raw materials through delivery of manufactured products to the customer. This makes it easier to recall defective or unsafe products, and helps the company pinpoint where problems occur in a manufacturing or sourcing process.
• Production control > The solution helps pharmaceutical manufacturers automate manufacturing formulation and pre-formulation management, execute production related activities via mobile device and achieve compliance with cGMP (current Good Manufacturing Practices) standards.
• Quality control > The adoption of the solution enables organizations to improve their production standards and manufacture high-quality products. The system accommodates regular quality control tests, result tracking and implementation of corrective actions without the need for a separate Laboratory Information Management System (LIMS). The quality management functionalities provided by the platform include configurable approval workflows, an electronic signature framework that complies with 21 CFR Part 11 and a fully embedded audit trail.