The project kicked off with an initial strategy workstream to define the overall ways of working, to assign roles for all team members, and to onboard the project management team. To begin the implementation phase, Kymanox performed a gap assessment of existing Quality Management System (QMS) processes and documentation to determine what content the new site could leverage from the other global sites in order to minimize implementation costs. Once a full accounting of the available information was completed, Kymanox began developing new or revised documents and training content with some improvements incorporated where feasible.
The key project objectives included:
-Drafting comprehensive documents for the new facility from leveraged materials such as existing policies and procedures and creating them from baseline reference materials available.
-Collaborating with personnel from multiple departments within the client company: Operations, Engineering, Quality Assurance, Quality Control, Logistics & Supply Chain, Manufacturing Sciences, and others.
-Working directly with subject matter experts (SMEs) to draft, review, and approve all documentation and training content.
-Producing cost savings and efficiencies by combining or simplifying documentation and training content where possible.
-Facilitating risk assessments to ensure training was assigned to site QMS procedures based on the perceived risk to patient safety.
-Producing training content to include eLearning/Computer-Based Training (CBT), Instructor-Led Rraining (ILT), assessments, and On-the-Job Training (OJT) modules.
-Tracking and reporting monthly on the deliverables, budget, and any project concerns.
-Finalizing the client’s QMS and phasing out the technical writing component of the project.
-Ensuring all work could stand the test of a regulatory body inspection to allow for commercial success.
Challenge
A Fortune 500 US-based pharmaceutical company needed support in the development of their site’s QMS and associated training programs required for Good Manufacturing Practices (GMP) operational readiness at a new site under construction.
Solution
Kymanox experts assisted the client with building the QMS system and offering continuous support over a multi-year contract.
Results
Kymanox created CAD and prototypes for three device iterations, performed hundreds of technical analyses to support scalable design, built almost 1,000 fully functional molded prototypes, and produced 250 clinical trial devices for three site clinical trial. We performed a risk-based technical assessment of the product. Kymanox also provided support for onboarding a clinical device Contract Manufacturing Organization (CMO) as well as identification of and tech transfer to a commercial CMO. Other deliverables included a turnkey eQMS with a fully electronic document management system, support for submission of two FDA pre-submissions and agency feedback, and completion of an n=150 device injection trial. Within 12 months of project initiation, Kymanox helped this client go from a whiteboard concept to clinical trial with their device. Now, they are on track for regulatory submission within two years of project initiation.