Medical Device Product Lifecycle Management
The Life Sciences industry is one of the most regulated industries in the world. For continued business success a Life Sciences manufacturer must be capable of innovative and speedy product development that delivers a quality and regulatory compliant product. To meet both business needs, Life Sciences manufacturers need to combine the Quality Management System (QMS) requirements with those of the New Product Development Process. The integration of regulations into the product development process simplifies the process and speeds up compliance. Life Sciences manufacturers turn to Integware to use their industry QMS/PLM expertise and best industry practices to define and optimize their business needs into a single environment.
Problems without Life Sciences Expertise
For many Life Sciences manufacturers, processes are not well defined, exist only in a
tribal-knowledge based approach, or are still paper based. The tools used are often not
suited for the job. While this may work these approaches come at a cost to the company.
The processes tend to be labor intensive, have a high risk level in regards to securing
continuous product quality and safety, and have high likelihood of development
inefficiencies. Without standardized processes, sustained product quality cannot exist
and it is likely that the organization will be at risk from regulatory findings. Integware
has witnessed good companies first hand be devastated by the FDA due to poor process
design. Even if compliance controls exist, processes may still be poorly designed and
enforced resulting in increased operating cost and decreased revenue
opportunities and not to mention employee stress.
Integware Life Sciences Expertise
Our expert team has an effective blend of automated product lifecycle
management process definition and Life Sciences development expertise.
We will help you develop your product development processes that are
QMS and 21 CFR Part 11 compliant using best practices, adjusted as needed
to any unique needs within your organization.
To do this, Integware will use the results of the QMS assessment (if
performed) as well as any other established process measures to assess the
existing process. Our product lifecycle and QMS experts will then lead your
subject matter expert (SME) team through an on-site workshop event called
a “Kaizen” (a Japanese word for improvement) to help redesign your processes.
The purpose of this activity goes beyond productivity and efficiency. A lean and
well organized process can significantly cut cost, reduce waste and improve top
line revenue. In addition, it can also reduce stress on the workforce by allowing
them to work regular business hours as opposed to significant periods of
overtime to get a product released or a change implemented. Your employees
will spend their time on value-add activities vs. mundane, administrative tasks.
Once the process is designed and agreed to we document the process both
graphically and in a formal Standard Operating Procedure (SOP). You will then
measure the process through agreed to metrics that will be defined in the SOP.