Regulated industries, life sciences in particular, have experienced significant changes in the regulatory environment in the past decade. The standards themselves haven’t really changed very much at all- whether it’s ISO 9001 which is focused on quality management, ISO 13485 which is focused on medical device quality management, or the technical standards such as ISO 27001. What has changed over the past 10 years is that the businesses responsible for implementing and maintaining the above standards are increasingly aware that not everyone can apply the same priority to all of the controls. The result is an increased focus on risk-based methodologies.
Each organization must decide and justify the systems and standards that they are implementing based on the value- or potential value- to the business. One of those decisions today includes the purchase and implementation of an electronic quality management system (eQMS). Ten years ago, if a business decided to invest in an eQMS, they would have had to maintain the staff and infrastructure to implement and manage the system.
Thanks to the advent of cloud-based infrastructure and software-as-a-service (SaaS), businesses now rely on solution providers and vendors to host and maintain their eQMS software. The technology is accessible from any location and any device, making it easier for organizations that have multiple sites and/or remote workers to utilize the system. And some software has even made it easy to implement and use.
Now that businesses are no longer required to have staff and resources available on-site to manage the ‘nuts and bolts’ or IT requirements associated with an eQMS, they can focus on their core competencies and metrics such as service level agreements (SLAs).
With the barriers to this technology lowered or even eliminated, life sciences companies of all sizes and maturity have access to enterprise-grade eQMS systems. Each business must still evaluate their motivation and desired business outcomes when deciding if and when they will pursue an ISO certification or strengthening their quality management system with an eQMS.
Often times, a life sciences business decides to pursue ISO certification for superficial reasons- either a customer has asked for it or perhaps a member of the leadership team was ‘sold’ a bill of goods at a trade event or conference recently. According to Ryan Coleman, ISO expert and consultant at DaySpring Technology, “The goal of an eQMS or an ISO standard is to improve the quality management, efficiency, and effectiveness of your business, and it is critical that business leaders do not lose sight of that.”
To learn more about the role of an eQMS in pursuing ISO certification, watch the video below featuring ISO Consultant, Ryan Coleman of DaySpring Technology.