The importance of a next generation QMS for EU MDR
Kari Miller, product management and regulatory leader, IQVIA, highlights five key characteristics of a next generation quality management system.
Every day, medtech and other life sciences organisations rely on their quality management system (QMS) to drive people and processes to improve product quality, minimise risk, ensure patient safety, and help maintain regulatory compliance. A next generation QMS delivers even greater value by taking an organisation’s quality maturity to the next level, also ensuring your operation is efficient and inspection-ready.
With the EU Medical Devices Regulation (2017/745) (MDR) and IVD Regulation (2017/746) (IVDR) medtech manufacturers are facing an increased focus on the links between regulatory activities and the QMS. The new EU Regulations are much more prescriptive than their Directive counterparts with regard to quality management systems.
Although the need for a quality management system is not new, MDR Article 10.9 and IVDR Article 10.8 now specifically require manufacturers to establish, document, implement, maintain, keep up to date and continually improve a quality management system to ensure compliance with the regulation. The quality system has to cover all parts of the organisation which deals with the quality of processes, procedures and devices.
In seeking to ensure compliance with the regulations medtech manufacturers may consider upgrading their QMS, so here is how a next generation QMS can advance quality maturity and examine the five key characteristics that enable the technology to optimise quality system performance.
Advancing your quality maturity
Quality maturity can positively impact the total cost of quality. Those organisations that are further along on their quality maturity journey benefit from a lower cost of quality.
As organisations increase in maturity, the focus moves to prevention, and the organisation becomes better able to anticipate and manage risk. This can be driven and supported by integrated quality and IT systems. In higher stages of quality maturity, companies become more proactive and can harmonise processes across the business and even beyond to better manage supplier quality and other contracted activities.
At the highest level of maturity, organisations are operating within a true culture of quality, with end-to-end quality processes and the ability for metrics to help sustain and improve overall quality.
The goal of this journey is to achieve higher stages of maturity to gain the benefits of higher product quality, improved compliance, and reductions in overall cost of quality.
Five key characteristics of a next generation QMS
- Built for life sciences – With stringent regulatory requirements, it is critical that your QMS is compliance-ready and closed-looped for accuracy and efficiency. A purpose-built, integrated QMS should help eliminate siloed systems, drive harmonisation, reduce overall cost of quality, and enable informed, data-driven decision making, while maintaining compliance with industry regulations and standards, such as 21 CFR Part 11, MDR/IVDR and ISO 13485.
- Quality intelligence and reporting – Easy access to complete and accurate quality system data is critical for making informed, data-driven decisions. Robust business intelligence (BI) combined with standard reports should provide instant feedback into quality trends, enabling your teams to make the right decisions at the right time. Personalised dashboards facilitate easy manipulation of data and adjust views to be relevant for the viewer’s role.
- Cloud – A highly secure, reliable, and efficient cloud environment will protect quality system data in an industry-compliant environment. The cloud should scale as the business grows in order to accommodate changing business needs.
- End-to-end eQMS deployment and optimisation – To optimise your next generation QMS deployment, the solution provider needs deep life science expertise for your journey to process harmonisation and proactive quality.
- Intuitive and modern user interface - Having a consumer-grade user interface improves user adoption and allows for the inclusion of myriad users across the organisation. The simplification of tasks improves user acceptance, utilisation, and inclusion. An intuitive user interface can assist in shortening cycle times, reducing errors, and minimising training needs.