Ensuring local Quality
meets Global Expectations

Quality Management & Compliance

Client: Swiss Pharmaceutical company 
Est: 1921  Size: 51-200

Project: Local PV management and quality services to prequalify distributors as LPPV in 11 EU countries.
Summary: Local liaison, translation of SOPs, GVP auditing, and CAPA reporting.

As a trusted European qualified person responsible for pharmacovigilance (EUQPPV) for an existing  global pharmacovigilance project, Arriello was the obvious choice when market expansion required local pharmacovigilance quality assurance support. The scope covered local PV management of distributors located in Hungary, Croatia, Slovenia, Poland, Czech Republic, Slovakia, the Nordics, Baltics and Greece, ensuring they were ready and able to deliver LPPV, literature screening, regulatory intelligence and more.

Challenges

There were two big challenges we needed to solve quickly for our client:

Communication.
Not only were there multiple language barriers to bridge, but each distributor required their standard operating procedures (SOPs) translated.

A co-ordination of communication made all the more difficult as there was also an authority barrier – the distributors were not under any responsibility to follow our recommendations, ultimately their contract was with the client.

Experience.
For the distributors the process of good pharmacovigilance was new. Meaning more time needed for explaining procedures, when little time was left on the clock to prequalify the distributors.

Solution

We needed to collaborate and communicate fast, and the most effective method was a remote teleconferencing schedule. This allowed us to easily explain and onboardthe distributors on the processes and next steps required of them. With both client and distributors in the loop and transparent on the project progress, our next task began – the skill of remote auditing.

Skilled, experienced, and most of all, confident in our abilities to pull everything together remotely, we managed to soon have the documentation required from the distributors rolling in. And almost as fast, our translations and analysis started rolling out.

With communication and experience the weakest link in the chain, each report was individually discussed with our client. The concise summaries and observations were made clear and easy to follow, including our expert guidance on how to implement corrective actions, preventive actions (CAPA).

With proactive support provided by the Arriello team on all solutions such as root cost analysis, sharing practices and how to fill the gaps the success of the project was assured.

Faster. Better. Smarter.

Empowered by Arriello’s faster, better, smarter approach, our client realised their local PV project in record time. We knew the faster thinking of teleconferencing and remote audits, powered by getting everyone into a “team mindset” to deliver the project, was critical to success.

The better way is often the simplest, and by collating all the translations and transparently keeping everyone involved in each step of the CAPA process, we kept the quality of service to the highest of standards expected by our client, and us. Finally, being smarter meant sharing our experience and proactively communicating how to take on board new learnings about auditing along the way.

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