After supporting more than a hundred eQMS implementations in my role as head of Operations here at ZenQMS, I have observed that the conversion from a paper-based to electronic quality management system (eQMS) can be either painful and cumbersome or quick and easy. The determining factors seem to be centered on the ‘health’ of the business’ quality processes- especially those related to document management and training.
Today's savvy quality leaders know that securing executive support and buy-in are key factors in successfully selecting and implementing an enterprise quality management system. Convincing skeptical C-suite colleagues of the strategic implications and costs of the current state can be challenging, especially in documenting both hard costs and intangible benefits/risks. It is necessary to speak in terms that they understand and appreciate, starting with Return on Investment (ROI).
Pressures are increasingly mounting for life science companies from multiple directions- customers, internal business stakeholders, and regulators. Quality leaders need to keep up with the latest regulatory updates in the life sciences industry and simultaneously scale and automate internal compliance and document control processes.