Originally published in April 2016

I attended the EXL GCP Proactive Compliance Conference in Philadelphia (March 2016) and there were many discussions on Clinical CAPA. I took part in some conversations, listened to some conversations and had the privilege of leading a Clinical CAPA roundtable conversation.

It is amazing to me we have been talking about this for years now in the industry and we do not seem to have moved much. Here are some of the common complaints:

  • We are using an Excel spreadsheet to record our incidents and CAPAs, we have not found anything user friendly
  • We are using the GMP system and we have adapted it as much as we could to our needs but it is frustrating and not easy
  • We have tried to use the GMP system, we struggled with it for many years and now we have gone back to using an Excel spreadsheet
  • Corporate is making use the GMP system so we make do

In my previous life, we had this issue and decided to approach it strategically. As a team, we started thinking of this system as a way to be proactive in our quality efforts. It sounds a little ironic considering CAPAs tend to be “used” once we have had issues but we focused on the “preventive” part. To be good corporate citizens and to complement our clinical operations group, we wanted to develop a simple system to identify and categorize incidents.

So, we developed a system with three main components (our three wishes) and put much effort into what we called the entry level, the operational incident:

  • We wanted a tool that would be useful to the Clinical Manager (CM) to track operational incidents (OI). This was a spreadsheet (well, yes, we had to start somewhere!) where the CM listed all the relevant incidents and categorized them. Instead of having each incident stored in her emails, the spreadsheet became a central tool. This has several clear advantages: centrally located, easy to access (have you had the pleasure of trying to retrieve emails from someone who has left the company and you do not know how they filed their information?), easy to transfer in the changing of the guards, etc. Let’s focus on the centrally located feature though. It means the CM can easily see if the incident type has already occurred and provide her with the opportunity to see if it is repeated. We all want to know if this is an isolated incident or potentially a systemic issue to be addressed swiftly as a quality incident.
  • The second component is the Quality Incident (QI). This was clearly defined and once again, we had a central tool.
  • This leaves the third component where we could have a clinical CAPA (cCAPA) based on different definitions (clearly a cCAPA, escalation from OI and/or QI).

Tip:  Here are two key aspects to ensuring we all understood:

1. Clear definitions – As a multifunctional team, we agreed on the definitions.

2. Alignment – We did training and ensured clear communication channels so the key individuals were clear on the concepts, how to use the tools and most importantly, on how to escalate issues in a timely manner.

Now, may I make another wish? If we could just have a user-friendly automated quality management system instead of spreadsheets…let me get back to you on this…

Skillpad helps clients in Pharmaceuticals, Biotechnology & other regulated industries to reduce costs, increase profitability and improve efficiencies. 

If you are interested in learning more about CAPA in pharma and biotech, check out Skillpad's e-Lesson: "CAPA for Nonconformities", written by our experienced Compliance Team using current real-world scenarios: 

Nathalie Bourgouin, PMP – Vice-President Compliance, Skillpad Canada Inc. is a leader in project management and a subject matter expert with an extensive background in risk-based quality assurance processes and training in manufacturing and clinical trials areas.

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