When Life Sciences organizations choose an ISO 9001:2015-certified partner, they can count on improved quality, reduced risk, increased efficiency, and more.
ISO 9001:2015 is an international standard that specifies requirements for an effective Quality Management System (QMS). A QMS is a set of processes and procedures designed to ensure that products and services achieve a level of quality that satisfies customers.
Business organizations that put effort into obtaining an ISO 9001:2015 certification—and keeping it current—can be trusted to provide:
When it comes to creating and implementing Enterprise Resource Planning (ERP) systems for pharmaceutical companies, biotech firms, and medical device manufacturers, AX for Pharma delivers industry expertise—backed by ISO 9001:2015 certification—as well as one of the most comprehensive and scalable solutions available.
AX for Pharma’s quality management team ensures that our Software Development Life Cycle (SDLC) is compliant with Good Manufacturing Practices (GMP) and other industry-specific regulations. As a result, our Customers will benefit from a Category 4 (Configurable) software per GAMP 5 guidelines, which significantly reduces the implementation and validation costs.
Because AX for Pharma is 100% dedicated to pharmaceutical companies, biotech firms, and medical device companies, we bring industry best practices and enterprise architecture excellence to your Life Sciences organization.
AX for Pharma’s mission is to give Life Sciences organizations the advanced technology they need for tackling the changes and challenges they face every day. As leaders in the discipline of process engineering and improvement, we’ve become a trusted advisor and resource for leading pharma, biotech, and medical device companies in the U.S., Europe, and Australia.
To learn how our comprehensive ERP solution—AX for Pharma 365™—can help your business drive growth, innovation, and efficiency, contact us today. Our configurable system, built on Microsoft Dynamics 365, is easy to implement and validate without the need for time-consuming and costly customizations.