In our previous post, we outlined some of the key challenges global biologics provider MedImmune—any many companies like it—had to overcome, and why it sought out an electronic system to manage its Environmental Health & Safety (EH&S) processes. In this installment, we’ll outline how the company came to choose TrackWise for management of these processes. The Solution: MedImmune’s EH&S team analyzed the company’s EH&S management information system (MIS) needs for the present and also looked at the expected growth for the decade ahead. The company’s initial plan was to then evaluate commercial off-the-shelf software systems in light of these requirements. However, the team decided to first investigate a parallel ongoing IT initiative to maximize existing investments in enterprise-wide software systems, including SAP and TrackWise®, Sparta Systems’ enterprise quality management system (EQMS).
The team determined that nearly all of MedImmune’s EH&S requirements could be satisfied within these existing systems. TrackWise is a flexible, configurable workflow management tool with multiple applications across the enterprise, which MedImmune had previously deployed to manage and track various quality management processes. MedImmune realized that the mechanisms for processes such as investigating and diagnosing root causes and implementing corrective/preventive actions (CAPAs) were identical, and therefore determined that EH&S requirements could be achieved through TrackWise.
According to Ron Clot, associate EH&S director at MedImmune, one of the most compelling factors driving the decision to use TrackWise for EH&S is that the core functionality is entirely configurable as opposed to having the vendor custom-code software to requirements – a very costly and time-consuming approach.
“With configuration using TrackWise, I can go through a menu and tick off what I want done,” Clot says. “I can make changes locally, and can change the workflows in an incredibly short time as the systems evolve. We achieved an initial seven EH&S workflows implementation within six months.”
Leveraging best-of-breed technology to deliver centralized and consolidated tracking, workflow management and regulatory reporting for all critical business processes, TrackWise also facilitates comprehensive audit management, including for audits relative to Good Clinical Practices (GCP), Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
“Our ability to take advantage of the audit trail TrackWise leaves behind is another key decision driver for us,” Clot says. “Many commercial off-the-shelf systems out there do not meet our standards.”
In the final installment, we’ll explore the distinct benefits MedImmune has received from its implementation of an enterprise quality management solution for EH&S.