This is my final topic in a series of blogs on helping you get the funding you need to implement a 21st century PLM solution — one that will let your medical device company move faster than your competition. The first blog laid the groundwork. My second blog highlighted how you need to focus on quality. The third blog discussed how to make your CEO and CFO look good.

In this blog, I’ll discuss the last strategy – take an all-inclusive approach.

According to Jan Welch, the head of coordinating medical device facility inspections at the Office of Regulatory Affairs once said that a culture that fosters quality in all areas provides the following benefits:

  • Enhanced process stability drives productivity and performance
  • Cross-functional skills and collaboration correlate to enhanced performance and productivity
  • Prevention reduces compliance risks and costs
  • Resources are streamlined, focused, and utilized to capacity.

Yet, how do you foster a culture of quality? I believe it is by taking an all-inclusive approach which includes all processes, all data, all connected, all related to the product – and useable by everyone!

Your goal is to solve the whole problem – not just a piece of it. This approach includes all of the following processes:

  • Design control
  • Device master record (DMR) management
  • Product structure & configuration management
  • Document control
  • Change management
  • Training management
  • CAPA, compliant, calibration
  • Process metrics, trends and analysis

Your goal is also to provide all the product information needed to create a quality product. This approach also includes:

  • Requirements and marketing info
  • Design history file (DHF)
  • Functional specs
  • Labels
  • Manufacturing process instructions
  • Quality information
  • Regulatory submissions
  • Device history record (DHR)
  • Calibration information
  • Validation and verification information

And all of this should be available to everyone – no special training required. It should be available from the corner office to the manufacturing floor and be easy to use with simple web access that runs on any mobile device.

Does all of this sound impossible? Sure it does – if you are using old solutions with old technologies. Yet, it isn’t impossible with an all-inclusive, electronic system that helps RA/QA executives enable quality, compliance and operational excellence.

Enable a case for quality — 3 key strategies summarized:

  • Focus on quality
  • Make your CEO and CFO look good
  • Take an all-inclusive approach

If you would like to explore how you can develop your own case for quality strategy and how QuadRite’s solution can help you, contact me at Or call our corporate offices at 408-337-0876.

To start from the series beginning, click here. To learn more about RitePro and how it will help you achieve operations excellence, click here.

Photo credit: Bigstock

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