Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company
More than ever before, Life Science quality professionals are feeling the pressure of increasing regulations and the rapid pace of business and industry-driven change. In previous posts, we’ve discussed these challenges, as well as the imperatives for the next generation of quality solutions that will help meet them. Next-generation enterprise quality management systems (QMS) must drive real product quality, link closely with business objectives, enable global harmonization, support enterprise quality, and enable an organization’s culture of quality. That’s a tall order for most quality systems that are deployed within Life Sciences organizations today.
Fortunately, there is a solution for next-generation QMS success. Pilgrim Quality Solutions, in its webinar, “Make the Move: Solutions for Next-Generation QMS”, examined the imperatives for next generation QMS, and provided success stories of Life Sciences organizations that have deployed next-generation quality strategies. We also walked through the journey to next-generation QMS and examined how Life Sciences organizations can move toward achieving this goal.
Beginning the Journey
For many organizations, the journey to next-generation QMS begins with a decision to move along the path to harmonization. Harmonization drives a common language and a common understanding around data and processes throughout the organization. This common language enables the organization to arrive at a single source of quality truth that’s aligned with business strategy.
Harmonization is different than standardization, where everything is exactly the same. Harmonization takes into account regional and local needs, and considers that which is unique to a process or product. When a process, whether a Corrective Action (formerly known as a CAPA), a Complaint, or a Change Request (to name only a few QMS components) is harmonized, at its heart lies a consistent and measurable DNA strand. It means that wherever the process is, the core of the process is common. Harmonized processes should reflect industry best practices such as ISO or GMP for compliance.
“At the heart of a harmonized process is a common DNA strand that is consistent and measurable across the organization.”
Common Language and Common Understanding
Another benefit of harmonization is the resultant common language. In this age of big data, structuring your global QMS information is imperative. Properly structured data sets are a must so that data can be turned into actionable information through its transformation. When properly structured quality data may be transformed into KPIs, metrics, and measures that can be used consistently at a business unit, division, or site level, you’ve achieved a common language. During the webinar, Angel Iglesias, Quality Manager and Global CAPA Steward for Boston Scientific, expressed that harmonization was one of the largest drivers and benefits of their global, next-generation CAPA process improvements. You can hear Angel’s comments on the benefits of harmonization below:
A Single Source of Quality Truth
One critical destination on the journey to global, enterprise-wide, next-generation quality management is arriving at a single source of quality truth for the organization. When this is achieved, everyone works from the same definitions and from a common set of data. This, in turn, drives consistency and organizational agility. It also improves the organization’s vision, because a single source of quality truth allows the Quality team to see and understand what is happening around the globe and how it measures up against business objectives.
Solutions for Next Generation QMS
Pilgrim has solutions to enable your journey toward harmonization, to help you arrive at a single source of quality truth, and to provide your organization with capabilities for next-generation QMS success. Pilgrim SmartSolve® starts with best-practice quality processes that reduce organizational risk, increase efficiency, improve organizational agility, and reduce cycle times by keeping tasks on track. With SmartSolve, compliance is built in so the focus can be on quality.
In addition to best-practice processes, SmartSolve provides organizations with a hierarchical data structure that provides the ability to look at your information, your KPIs, and metrics at all levels in the organization. It also allows for the rules-based configuration of your processes, ensuring a harmonized process that does not lose sight of regional or country-specific requirements.
SmartSolve also provides appropriate reporting for the role of each user. This includes end-user things-to-do dashboards, searches and detail reports, management reports, metrics, and KPIs, as well as executive dashboards, trending, and predictive analytics. Management dashboards and metrics provide the link to corporate strategy and objectives that enable executives to understand the impact of quality.
The Benefits of Next Generation QMS
There are many benefits to making the move to next-generation QMS, but the real goal is the achievement of customer expectations. These are achieved through the identification, diagnosis, and ultimately, the prediction and prevention of quality problems across the organization’s value chain. Product and operational excellence improve customer satisfaction by ensuring that products meet customer requirements and are available when and where they’re needed. Next-generation QMS, or EQMS 4.0 as it is being referred to, is also a key step to positioning companies for Quality 4.0 initiatives, well described by LNS Research. Next-generation QMS and EQMS 4.0, and their increased focus on quality will drive top-line revenue, reduce cost, and therefore improve the bottom line.
Make the Move
Learn what it takes to move beyond compliance and make an impact on product quality and patient safety.