Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions
LNS Research recently hosted a webinar highlighting steps to help Life Sciences firms address quality challenges. The webinar presented three quality-related initiatives that have delivered measurable business results. Each concept is outlined below, followed by the infographic that summarizes the findings from LNS’ research.
Culture of Quality and Compliance
Companies paving the way for operational excellence focus on embodying a culture of quality. This includes leveraging their Enterprise Quality Management Software (EQMS) to improve visibility into their processes, empower decision-making, encourage product and process improvements, and facilitate collaboration throughout the organization to reduce CAPAs, complaints, and nonconformances.
Effective Closed-loop Processes
It is important to close the loop on quality processes to gain insight into the entire quality management value chain. As you can see below, only 22% of Life Sciences organizations surveyed have effective closed-loop processes. Aim to become part of this segment by implementing an EQMS that electronically integrates key components of your quality management system. With an EQMS, you can access your current, controlled documents from anywhere in your quality system; you can feed multiple types of defects into a streamlined CAPA process; and, you can drive training requirements from document changes, even alerting you when an employee certification has expired.
Tight Integration between MOM and EQMS
Your car needs both gasoline and oil for the engine to run, but the two would never mix together. You keep them separate, keep the lines clean, and keep your engine running smoothly, yet your car needs both to function. Similarly, EQMS and Manufacturing Operations Management (MOM) each have a separate role to play, but should work together to keep your operations running smoothly and remain compliant with industry regulations. MOM documents in-process manufacturing information while your EQMS documents and controls downstream quality processes. By more tightly integrating these two, you can help drive your company toward a culture of quality, while further closing the loop on quality processes.
Companies must ensure quality not only in the manufacturing environment, but across the drug or device lifecycle. We’ve discussed in the past that this takes three main things: an effective culture driven by strong leadership, the move toward closed-loop processes, and the use of next-generation technology.
Mike Roberts, LNS Research, New Data: Life Sciences Needs Tighter Quality-Manufacturing Integration
Download the e-book on this topic to learn:
- Why quality management and manufacturing traceability are becoming the top two challenges in the Life Sciences industry today.
- Why momentum is growing for both EQMS and MOM software.
- Industry benchmark KPI data for Products in Compliance, New Product Introductions, Overall Equipment Effectiveness, and On-Time Complete Shipments.
A Roadmap for Addressing Quality and Manufacturing Challenges in Life Sciences