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Is everyone on board with quality management systems?

By Jill Healy

I recently attended the Inspection Readiness Summit in Philadelphia, PA this past week.  The room was full with top level QA representatives from biotech/pharmaceutical companies and then there were only two CROs in attendance, Trial Runners being one.  The Summit was amazing as we discussed risk mitigation strategies, work processes and inspection readiness preparations.  We, the key attendees in the room, are the designers of these processes and fully understand the expectations.  But we were missing just one thing: everybody else!

Quality-300x300.pngWhen it comes to quality, it’s not a process that can be created and mitigated without everyone’s buy in.  This includes IRBs, sites, specialized vendors and regulatory departments.  We all want to perform quality work, that’s the easy part, the hard part is everyone having the same definition of quality.

I am proud of the quality culture that Trial Runners is driving with - We have some pretty incredible metrics and work flow charts to represent it!  But Trial Runners, as a CRO, is only one piece of the clinical research pie.  What this room full of the best and brightest in the industry did not discuss is how we get this quality culture, that is represented in one company, to become a quality revolution in the industry. 

Change takes time and there will be battles won and lost, but leave nobody behind is our first rule when it comes to increasing our quality standards.  There should be more tools regarding quality that are readily available and free for all clinical research professionals to use that can be adapted to fit any organization’s size and budget.

Let’s learn the quality language together so that are all on the same page: 

QMS = Quality Management System

This means your organization has to have a documented plan to oversee quality.  If you don’t have a plan for the QMS – drop me a line, I would love to give you our tool that we use, free of charge.  It’s easy to follow and adaptable for any organization.

 Let the revolution take over!

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Filed under: Quality Assurance, Quality, Quality Management System