Does it Matter if Your ERP Partner Is ISO Certified?

The FDA is pressing for new authorities to help mitigate disruptions and shortages. 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:

• Improved Quality ISO 9001:2015 certification demonstrates that a company has a robust QMS in place.

• Reduced Risk ISO 9001:2015 certification shows that a company has viable systems for identifying and correcting potential problems, thus reducing the risk of defects and errors.

• Increased Efficiency ISO 9001:2015 certification verifies that a company has streamlined processes and eliminated waste, which can lead to cost savings and improved productivity.

• Enhanced Customer Satisfaction Because ISO 9001:2015 certification leads to better quality, companies with the designation generally boast higher customer satisfaction scores and repeat business from several long-term customers.

Make STAEDEAN Your ISO-Certified ERP Partner

When it comes to creating and implementing Enterprise Resource Planning (ERP) systems for pharmaceutical companies, biotech firms, and medical device manufacturers, STAEDEAN delivers industry expertise—backed by ISO 9001:2015 certification—as well as one of the most comprehensive and scalable solutions available.

STAEDEAN'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 STAEDEAN 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.

STAEDEAN'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.

Our configurable system, built on Microsoft Dynamics 365, is easy to implement and validate without the need for time-consuming and costly customizations.

Discover how STAEDEAN's Life Sciences ERP solution can help your business drive growth, innovation, and efficiency.