As a supplement company, Ortho Molecular is subject to strict FDA regulations which include oversight of its change management practices. Changing a supplement formulation, manufacturing process or even product language requires appropriate controls to ensure consumer safety is maintained.
Previously, those change requests were handled through a manual, paper process. Ortho Molecular contracted Omni Resources to automate that workflow.
After several process analysis sessions, Omni’s team could see that Ortho Molecular’s existing workflow software wouldn’t provide the sophistication and complexity required. Omni introduced the K2 workflow framework because it could support the robust information architecture necessary for the project.
The new K2-based workflow is highly secure, enabling Ortho Molecular to demonstrate strict change management practices in compliance with FDA regulations. Using the new system, Ortho Molecular expects to manage hundreds of change requests at any given time, each of which may require different approval stages.
Build-in flexibility provides the framework to create non-standard change requests. Plus, the K2 workflow solution will deliver full archiving capabilities, allowing the company to generate an audit trail for any tasks managed through the system.
The K2 application will also help increase productivity by creating transparency into project bottlenecks and allowing work to be shared more efficiently among employees. What’s more, K2 certified developers at Omni are coaching Ortho Molecular’s K2-based workflow applications. Plans for the future project iterations will include electronic signature capabilities along with the creation of several workflows to handle all of the action items required for a given change request.
With the project entering final testing, the expected impact is a significant reduction in the time required to initiate and process a change request, as the system will minimize miscommunications and rework. Meanwhile, thanks to Omni’s mentoring, the Ortho Molecular staff is well positioned to maintain and enhance the system after it’s been implemented.