There’s no doubt that the world becomes more interconnected and technology-centered as each day passes. Driverless cars have taken to the road in pilot projects in several countries; modes of communication are instant and global, whether they’re under 140 characters or above; and medical treatments are being tailored to fit personal genomics.
As available products and services become more technologically complex, one might be forgiven for assuming that all the required processes and technology to get them to the marketplace are similarly advanced. In many cases this is indeed true, but many people might be surprised to learn how prevalent manual and localized processes are for managing product quality across industries.
Unfortunately, the gap between quality needs and actual EQMS investment is nothing new. In 2008 Nora Dyer, Global Head of Clinical Development Operations at Novartis, suggested that a lack of understanding among key decision makers is the biggest hurdle to adopting an automated solution. “Adoption of e-solutions is hindered when important stakeholders do not clearly understand and support the overall business rationale,” said Dyer, “and don’t drive towards the change. Therefore, an effective communication strategy using multiple channels to reach the end-user is essential for a successful implementation.” 1
Most quality professionals see the need for an EQMS system. But the main challenge today, as in 2008, seems to be focused on executives and the budgets required to implement an EQMS system. As the data from 2008 and the more current data from LNS indicates, companies’ budgets are still being spent on what are perceived to be higher, more immediate priorities. Yet, improperly prioritizing EQMS can cost a pharmaceutical company millions of dollars each year, as well as cause them to lose market share to competitors who have already successfully invested in an EQMS system.
Build a business case for an EQMS investment. Leverage benchmark data on operational and financial performance improvements experienced by organizations with EQMS versus those without EQMS. Use performance data on metrics such as OEE, percent of products in compliance, on-time deliveries, and rate of new product introductions to quantify an ROI and build a business case.
Evaluate EQMS solutions providers. Take a comparative approach to researching the EQMS solutions vendor market and develop a future vision matching ideal requirements. Evaluate each vendor with a live demo. Consider vendors able to serve current ideal requirements, but also those investing in emerging technology trends such as big data analytics.
Implement EQMS functionalities and prove value. Some organizations may find it optimal to deploy entire EQMS suites of functionality, while others may have budget for only specific functionalities and choose to implement modularly. After making a solution selection, deploy EQMS functionalities as business needs permit.
There are many aspects of these EQMS steps on your journey. They interrelate and overlap, each with its own importance in reaching your final goal of an implemented EQMS with desired scope, functionality, and timing that delivers the expected ROI, and hopefully keeps the implementation going, through a broadened rollout in location, functionality, or both.