Ensuring local quality
meets global expectations.
Client type.
Geography.
Lifecycle stage.
Service area.
Summary
Local liaison, translation of SOPs, GVP auditing, and CAPA reporting.
The scope covered local PV management of distributors located in Hungary, Croatia, Slovenia, Poland, the 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 onboard the 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.
Through confidence and experience we quickly had the documentation required from the distributors alongside all translations and analysis.
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 teleconferencing and remote auditing was a faster approach to getting everyone into a “team mindset” to deliver the project and critical to success.
The better way is often the simplest – by collating all the translations and transparently keeping everyone involved we kept the quality of service to the highest of standards expected by our client, and us.
Sharing experience and proactive communication is always smarter way to run projects at a distance.
More Quality Management case studies
View all
