Cegeka's Pharma & Life Sciences solution now available on Microsoft AppSource

Cegeka Pharma & Life Sciences is a comprehensive solution designed specifically for the pharmaceutical and life sciences industries on Microsoft Dynamics 365. The solution addresses the unique needs of these highly regulated sectors with features designed to ensure compliance, improve efficiency, and enhance quality control. 

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. 

"Cegeka Pharma & Life Sciences sets a new standard in the industry," said Stijn Geeroms, Global Director Business Solutions at Cegeka. "Our advanced solution leverages the agile capabilities of Microsoft Dynamics 365 to help our clients accelerate growth, enhance operational efficiency, and drive innovation while achieving regulatory compliance. Our goal is to empower pharmaceutical and life sciences companies to succeed in a highly competitive and regulated landscape." 

“Microsoft welcomes Cegeka Pharma & Life Sciences to AppSource, where global customers find thousands of line-of-business partner solutions that work with the Microsoft products they already use,” said Giovanni Mezgec, Vice President, Modern Work + Business Applications Field & Partner Marketing, Microsoft Corp. “AppSource and trusted partners like Cegeka help customers do more with less by increasing efficiency, buying confidently, and spending smarter.”