How the Right ERP System can Make GMP Compliance Simple

Massimo Crudeli

Jul 11, 2023 9:00:00 AM

Enterprise Resource Planning (ERP) systems can help life sciences organizations comply with Good Manufacturing Practices (GMP)

Good Manufacturing Practices (GMP) are guidelines that govern the manufacturing of a wide range of products intended for human consumption and use, including medical drugs and devices. For life sciences organizations, agencies like the FDA enforce these regulations to ensure the quality and safety of manufactured products.

A powerful and comprehensive Enterprise Resource Planning (ERP) system can help pharmaceutical companies, biotech firms, and medical device manufacturers comply with GMP guidelines across all aspects of the manufacturing process, from raw materials to finished products. Here are some examples of how life sciences organizations can more easily follow and enforce GMP guidelines with the right ERP system in place:

Real-time data An ERP system can help Life Sciences organizations track and manage all the data related to materials, equipment, procedures, and processes. With all data housed in a central repository and updated in near real-time, Life Sciences companies can more easily do things like prevent untested materials from contaminating their products.
Audit trails Regulatory bodies often ask life sciences organizations for documentation of data access, data changes, and inventory transactions. An ERP system can rapidly create detailed reports that satisfy such inquiries.
Process control An ERP system can help streamline operations and eliminate human errors. Control over storage conditions, for example, significantly reduces the risk of misplacing temperature-sensitive material that can quickly deteriorate, and embedded dispensing capabilities eliminate the need for costly interfaces and reduce the risk of duplicated data.
Quality control and assurance The best way to assure quality is to identify and address issues as quickly as possible. With an ERP system that offers advanced analytics tools and automatic alerts, life sciences organizations can be more proactive about quality.

STAEDEAN's configurable Life Sciences Management ERP solution, built on Microsoft Dynamics 365, is easy to implement and validate and has been proven effective with leading pharmaceutical companies, biotech firms, and medical device manufacturers in the U.S., Europe, and Australia.

Massimo Crudeli

Share