EQMS Integration and Interfaces: GxP Activities, ERP & LIMS Systems
EQMS - 29 July 2015
Many companies are seeking a level of integration between enterprise software solutions of various types—to the extent that all of these systems will share information in real time. Other companies spend worker-months designing, testing and attempting to validate the sharing of data and files between different systems interchanging data. The question is to what end? Each system has its primary purpose and stated intent for its use, and its own strengths and capabilities that should be leveraged.
In the life sciences industry, the responsibility for the approval of products for distribution (by health care providers) and for use (by patients and consumers) lies with the Quality Unit of each entity, corporate or otherwise. I believe that performance of that responsibility should necessarily involve some human intervention steps to confirm the acceptability of the material.
I am frequently asked by my clients in the life sciences industry as to what (which activities?) should be managed where (in what system?).
The following are my thoughts and recommendations on some specific GxP related activities:
1. Inventory Management, Production Planning and Scheduling, Purchasing and Finance activities and tasks, for example, are best handled in an ERP system:
• Material descriptions should be managed in an ERP system.
• The Approved Supplier List should be managed by the ERP system with approval from Quality.
• Material status changes should occur in the ERP system with ability to change the materials status limited to Quality.
• Material status should not change automatically through an interface between a LIMS, EQMS and the ERP systems.
2. Laboratory operations should be managed in a LIMS system.
• Sampling plans and activities should be managed in LIMS.
• Inspection results should be managed in LIMS.
• Tests results and their comparison to the specification should occur within the LIMS.
• All data and meta-data associated with a result should be managed within the LIMS.
• The CoA should be issued by the LIMS.
• The only interface required to a LIMS is the one that will notify the laboratory that sampling and testing activities are required, based on receiving or manufacturing/packaging activities.
3. All Quality management activities should be managed in an EQMS.
• These activities include Deviations, Investigations, Non-Conformances, CAPAs, Change Controls, Complaints and Audits, Document Control, and Training.
• Automating material status change automatically through an interface between the EQMS and the ERP system is not a priority.
About the Author
Brian Graeff is currently the Head of the Quality Best Practices Unit at SOLABS. He is also the President of “Brian Graeff LLC” an independent consulting company providing Quality Systems and GMP consulting services to the pharmaceutical industry. Brian’s career in the pharmaceutical industry spans over 40 years during which he held various management positions in Quality Assurance, Quality Control and Production with Sterling Drug-Winthrop Laboratories, AstraZeneca and Sunovion. Brian retired from Sunovion Pharmaceuticals Inc. in December 2010, where he served as the VP of Quality Operations. During his career, Brian helped manage many different drug products and API’s with the majority of his experience being with parenteral, respiratory and tablet dosage forms. Brian brings a wealth of experience in pharmaceutical manufacturing, quality management, FDA interactions and CGMP interpretation and implementation to the table. He believes that “Focusing on the Fundamentals” is the key to product quality, compliance and maintaining a company’s license to operate.