Why a Harmonized Quality Management System Should Be a Key Focus for Your Life Sciences Firm
Increased regulatory scrutiny and fast-paced release cycles work together to make pursuing quality difficult for life sciences companies. The dual pressures of ensuring quality in existing products as well as during the research and development stage often lead to high overheads as firms strive to keep up with the resulting demands. Many organizations address these problems as separate issues, but this approach can result in disparate systems that are inefficient and unwieldy. In order to cope with the challenges of remaining competitive in a crowded market, life sciences companies should unify their quality processes into one harmonized system.
Changing How Firms View a Quality Management System
One of the largest obstacles to an effective quality management system stems from perspective. More often than not, quality is viewed as a department rather than a company-wide ideal. In a survey conducted by LNS Research, more than 50% of executives said that employees without quality-specific duties often failed to take into account the impact of their decisions upon operational and manufacturing standards.1,” April 2, 2013, http://blog.lnsresearch.com/bid/176069/3-Reasons-Why-Closed-Loop-Quality-Management-Strategies-Fail-DATA] Because of this dispersed view of quality management, companies tend to use disparate systems and strategies that add inefficiencies and bottlenecks to the enterprise.
Rather than viewing quality management as the responsibility of a select few, life sciences firms need to adopt a company-wide culture that emphasizes it. Embracing a quality culture leads to reduced costs, lowered compliance risks and better performance overall.2 Even more important, this shift in thinking must begin at the executive level. Not only does support from the top encourage all employees to consider the effect they have upon quality in the long-term, it also minimizes the adoption of disparate management strategies. Instead of using a system that supports quality in only one department, the company can focus on incorporating technologies that improve quality across multiple areas through communication and collaboration.
The Benefits of Using a Harmonized Quality Management System
Despite the pervasiveness of a digital culture that favors electronic applications, many quality management systems remain paper-based. The reliance of quality strategies upon these obsolete methods only fuels further inefficiency due to lack of centralization and the existence of multiple data sources. If collaboration and communication form cornerstones to a successful quality management system, then the tools a company adopts must support those aims. A paper binder containing quality management procedures may work at the local level, but it fails to live up to the requirements of today’s life sciences organizations, many of which are large enough to have branches located across the globe. How can all of a firm’s employees buy into a holistic view of quality culture when access to the components of that system remains limited?3
Moving away from paper-based processes is only the first step in adopting a harmonized quality management system. There are a vast array of digital tools that support quality, ranging from electronic laboratory notebooks to chemical inventory systems, so many options abound for organizations seeking to make the transition. But before a company adopts tools for specific tasks in the quality chain, they need to make sure a harmonized strategy is already in place. Otherwise, firms run the risk of adopting redundant technologies that overlap or duplicate processes rather than streamline them.
Establishing a harmonized strategy may sound daunting, especially for large life sciences organizations with departments used to following their own unique quality procedures. But rather than viewing this shift as a radical change, it should instead be treated as a foundation from which all departmental quality systems stem. A unified quality management system is a single concept that governs all quality systems at every step of the way, from discovery to final product testing.
If your company is interested in learning how a unified management strategy forms the backbone of any quality strategy, please contact us today to request a research spotlight or to learn more about the BIOVIA Total Quality Solution.
- “3 Reasons Why Closed Loop Quality Management Strategies Fail [DATA ↩
- “What Gets Measured Also Gets Measured,” January 10, 2013, http://www.qualitydigest.com/inside/quality-insider-column/what-gets-measured-also-gets-managed.html ↩
- “Electronic Quality Management Systems Are Worth the Money,” July 7, 2009, http://www.qualitydigest.com/inside/quality-insider-article/electronic-quality-management-systems-are-worth-money.html ↩