Pharmaceutical companies all over the world are choosing it for its unique, customised capabilities
Rebecca Gibson |
This article was originally published in the Winter 2018 issue of The Record. Subscribe for FREE here to get the next issue delivered directly to your inbox.
Simple to use, Microsoft Dynamics 365 is an enterprise resource planning (ERP) business solution that integrates core business functions across an organisation to support industry-specific and operational processes. The platform can be hosted by a partner, deployed in the cloud or implemented on-premises and offers flexibility, cost effectiveness and security. It connects with key Microsoft products, such as Outlook, Windows Server and Exchange Server, while the cloud version also integrates with Office 365, Skype for Business, SharePoint, Power BI and PowerApps. It’s easy to see why Dynamics 365 is at the crux of the AX for Pharma pharmaceutical solution.
AX for Pharma Dynamics 365 (D365) is designed to meet the full range of ERP needs of pharmaceutical and life sciences companies who want to manufacture high quality products in the most streamlined, cost-effective and compliant way possible. The solution has integrated systems for laboratory information management and manufacturing execution, as well as functionalities for advanced batch and sub-batch management, batch numbering, shelf-life date tracking and much more. Hence, the commercial off-the-shelf solution makes it easy for companies to manage the processes involved in producing and distributing medications. It also enables them to comply with current Good Manufacturing Practice (GMP) regulations, US Food and Drug Administration requirements and other guidelines.
Weighing and dispensing ingredients precisely is a critical part of the manufacturing process. Consequently, AX for Pharma D365 has a Weighing & Dispensing module, which simplifies tasks while enabling manufacturers to retain a high level of control and visibility throughout the process to ensure traceability and regulatory compliance. Dispensing requests can be linked to production picking lists and lab technicians can use integrated electronic scales and barcode devices to accurately calculate and dispense the right quantity of ingredients. Pharmaceutical manufacturers can also create instructions for lab technicians to refer to during the weighing and dispensing processes to prevent cross-contamination, safely handle products.
Meanwhile, the Basic Pharma (BPH) module plays a crucial role in helping pharmaceutical companies comply with global legislation, which demands that each individual product is tracked as it passes through the supply chain. It supports logistics processes by offering users extensive capabilities for tracking samples, batches and containers; configuring specific storage conditions for each drug product; and for automatically printing labels. In addition, the Advanced Warehouse Management (AWM) module provides warehouse operators with mobile-friendly access to real-time information about inventory and the status, shelf-life and handling instructions for containers.
Quality management and quality control is essential throughout every phase of the pharmaceutical manufacturing process – without it, companies are at risk of producing non-compliant products that may be unsafe for human consumption. Typically, companies have to invest significant time, resources and money to implement add-on solutions to their ERP system to meet GMP guidelines, regional and international regulations, and customer requirements. However, AX for Pharma D365 users have access to all the comprehensive tools they need via the Advanced Quality Management module.
The module provides extended item and sub-batch testing and sampling capabilities, as well as tools to validate and review quality orders. Users can also print GMP-critical Certificates of Analysis/Conformity by item, customer, country, manufacturing site and analysis type to prove that products comply with customers’ requirements.
In addition, the AX for Pharma D365 platform allows pharmaceutical manufacturers to create approved vendor and manufacturer lists, and electronic signatures that comply with US Food and Drug Administration requirements.
Together, all the modules and functionalities within AX for Pharma D365 empower pharmaceutical companies to gain a full overview, and complete control, over their entire manufacturing, warehouse and distribution, and supply chain processes. This streamlines processes, reduces human error and helps companies to develop, manufacture and distribute safer drug products in a faster and more cost effective and compliant way.