The right Enterprise Resource Planning (ERP) system can help life sciences organizations enhance compliance with Good Laboratory Practices (GLP).
Good Laboratory Practice (GLP) is a system of quality management controls, designed to ensure the consistency, reliability, reproducibility, and safety of therapeutics and other products intended for human consumption and use. In the U.S., the Food and Drug Administration (FDA) maintains and enforces GLP guidelines for the nonclinical studies undertaken by Pharmaceutical companies, Biotech firms, and some Medical Device manufacturers.
GLP covers many operational aspects of life sciences organizations, including supply chain management, quality management, and laboratory information management. Tracking biospecimens, calibrating instruments, inventory control, security, and equipment maintenance are just some of the activities governed by GLP.
An Enterprise Resource Planning (ERP) system can be a valuable tool for life sciences organizations that want to ensure—or improve—their compliance with GLP guidance. By creating a reliable source for the most up-to-date data, life sciences organizations can ensure the quality and integrity of their studies, facilitate study reconstruction, and provide overall accountability.
ERP systems remove the risk of human error that comes from the use of manual, outdated data collection and management methods, such as spreadsheets. What’s more, by creating a single source of truth for all lab-related data, study investigators can generate specific reports and derive valuable insights from the data they collect. This capability can benefit current and future studies and deliver a better return on R&D investments.
Without an ERP system, life sciences organizations may find compliance with GLP regulations much more frustrating and difficult, which can lead to fines, penalties, and other sanctions from regulatory agencies.
AX for Pharma is the market leader in ERP solutions for Pharmaceutical companies, Biotech firms, and Medical Device companies. Built for native compatibility with Microsoft Dynamics 365, AX for Pharma’s modules deliver the most comprehensive suite of data management solutions for life sciences organizations.
Our AXP365 Advanced Quality Management™ module, for example, is a powerful solution that streamlines and automates sample management, certificates of analysis/conformance, stability studies, environmental control monitoring, approval workflows, and more.
The LIMS component of AXP365 Advanced Quality Management™ delivers visibility into every aspect of laboratory operations and provides unparalleled accuracy, data analytics, assurance metrics, and rules-based decision support (e.g. batch release).
Through real-time communication and visibility throughout your operations, our integrated digital quality management solution helps ensure product excellence and cost control—plus GLP compliance—at a fraction of the cost you’d expect.
And if you need to connect your GLP activities to other business applications, our Connectivity Studio gives you a convenient, business-focused way to set up and manage integrations.
To learn how AX for Pharma can help your organization better comply with GLP and better manage your nonclinical studies, contact us today. Our configurable solution 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.