Last time, I covered the top 9 deficiency areas that regulatory agencies in the EU and US encounter when inspecting medical device, combination product and drug product manufacturers.  There were many similarities between the gaps found across these three disciplines.

It seems only natural to then share a way of pro-actively attacking these gaps, so here it is….

Around the middle of last year, we were asked by a client to help them prepare for pre-approval inspection for their new medical device.

Like them, you may have developed a medical device or combination product, and particularly if you’re getting ready for pre-approval inspection or routine audit, you may want to know more about the areas that could be investigated.  As with many things in our industry, the FDA take the lead in describing the scope and content of their Quality System Inspection Technique (QSIT for short).

In brief, the QSIT approach describes four areas that investigators can cover during an inspection (they typically cover at least 2 of them);

  • Management & general points
  • Design Controls
  • Production & Process Controls
  • Corrective and Preventive Actions (CAPA)

Our client had heard about the QSIT approach and decided they wanted to use it as the framework for our preparation activities together.

navigating the complexity of QSITNow, we could have dived straight in to the published QSIT guide and tried to use it to assess their systems, documentation and development history.  I’m so glad we didn’t, as we’d probably still be waiting to be rescued.  Instead we built upon an approach shared by one of our associates, to;

  • Ask a structured series of questions in each of the four areas
  • Find the gaps or issues that investigators could uncover
  • Describe the “ideal response”
  • Craft one or more practical solutions to close these gaps and reach the “ideal response”
  • Support their people in implementing these solutions.

Our work together was greatly appreciated, particularly coming up with solutions to issues that we uncovered and helping put them in place as we went along; knowing when to stop digging for issues and when to move our gaze onto filling in the holes. Essentially we ended up with a traceability matrix from QSIT expectations through to the “ideal responses” and the documented evidence of compliance.  Useful for the back-room during an inspection too.

You’ll appreciate that managing the issues, prioritising their resolution and tracking closure is no small task.  You may be relieved to learn that we did it all in a straightforward spreadsheet, even using it to report KPIs to management.  In the time available, we focused upon resolving the most critical issues, then those that were less likely to kill an inspection.

An isolated success?  I don’t think so, as two additional clients have since embraced this way of working with us, in preparing for inspection.