Life Sciences companies are subject to Good Manufacturing Practices (GMP) guidelines and country-specific regulations, such as those issued by the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) in Europe. As a result, in regulated industries, the vendor selection process is made with a great deal of scrutiny.
Vendor qualification is the process of assessing, approving, and maintaining records of select vendors, contractors, and supplier companies that provide critical materials, parts, services, and/or equipment to an organization. The purpose of the vendor qualification process is to ensure that supplier companies provide products and services in compliance with regulatory requirements. AX for Pharma 365™ builds on Microsoft’s technology to offer life sciences companies improved ways to conduct vendor qualification.
Microsoft Dynamics 365 Finance and Supply Chain Management provides fully configurable questionnaires to facilitate the evaluation of potential vendors. Life sciences companies can use this solution to control, qualify, and monitor suppliers that provide regulated items such as active ingredients.
Users can then review answers provided by suppliers to ensure product quality, capability, consistency, and reliability.
Among its many functionalities, Microsoft Dynamics 365 allows users to define a list of approved vendors for every material and to specify the validity period for each combination. The system controls which vendors can be selected when a specific product is added to a purchase order and even block all the transactions for unapproved or expired vendors.
The AXP365 Advanced Quality Management™ module enhances the standard capability to support the GMP requirements of vendor qualification and offers a vendor status that can be configured and assigned by authorized users to each item-vendor combination. As a result, the system can automatically trigger the proper sampling plan and apply reduced testing policies when quality orders are generated upon material receipt.
Vendors often acquire material from the actual manufacturers, so the vendor qualification process is not enough for life sciences industries.
AX for Pharma 365™ allows the control of manufacturers and to define the list of approved manufacturers for each product. AXP365 Advanced Quality Management™ verifies that the manufacturer selected on the purchase order belongs to the list of approved manufacturers. Life sciences organizations can use AX for Pharma 365™ to block all the transactions for unapproved manufacturers.
Additional configurations allow for the automatic generation of a quality order upon product receipt based on the specific item-manufacturer or item-vendor-manufacturer combination.