Making the Move from Paper to Electronic Quality Management

When and how to implement an electronic quality management solution are persistent questions for small and medium-size life sciences companies. The recent webcast hosted by Pharmaceutical Technology and sponsored by Sparta Systems called, “What Early Stage Companies Need to Know About Quality Management: Lessons Learned from Industry Leaders” provided insight to help companies planning to move from paper to electronic processes . Tim Mohn of Sparta Systems started the program by presenting the “big picture” on the topic of QMS, including triggers for adoption and key benefits. Tim’s poll of the audience showed over 76% are still using at least some paper-based processes, and that the biggest obstacles to implementing a QMS for over 55% of respondents are proving ROI and getting employee resources to support the project. In the panel discussion that followed, quality management professionals, Jinna Penachio from Alkermes and Roland Smith from Shire HGT were interviewed by John Lyons of Maxiom Group. Jinna and Roland spoke based on their experiences implementing QMS to support deviations, CAPAs, investigations, change control, training management and other key processes.

The panelists offered practical advice on how to address the ROI and resource obstacles faced by the audience. Other topics of discussion included the key business drivers for implementation, how they got approval for the investment in QMS and the key lessons learned along the way, particularly as related to engaging key stakeholders.