Leveraging prior experience to fast track preparations thumb.

Leveraging prior experience
to fast track preparations.

Client type:

Biopharmaceutical.

Geography:

USA.

Lifecycle stage:

Post-marketing.

Service area:

Quality Management.

Summary.

  • Audit support, gap analysis, documentation preparation and cloud hosting, mock inspection.

  • With less than one month’s notice to prepare, with the added pressure of an unexpectedly delayed agenda which came only a few days before the audit, we successfully empowered the client through activities that identified and avoided gaps, facilitated documentation preparation and ensured guidance throughout the entire process.

Challenges.

Short deadlines are nothing new for Arriello. Last-minute client requests in preparing for audits are always met with our calm reassurance of success. However, enabling a client to be ready for inspection in less than a month is still a challenge. And that’s before overcoming the hurdle of a late announcement of an audit inspection.

A month, a few days, it all simply adds up to testing how fast and efficient you can draw on prior knowledge and re-organize resources (internally and externally) to fully support the client’s needs.

Solution.

With the clock ticking, being proactive and communicating person-to-person are both essential. With this is mind, we quickly reorganized team resources (internally and externally) while getting everyone up-to-speed by holding several face-to-face meetings with the client. Without delay we wanted to walk our client through all the likely issues they might encounter during the inspection – such as a review of the inspection agenda, gap analysis and even guidance for activities beyond the initial scope.

Our prior experience of helping other clients navigate Swiss medic inspections gave a unique intelligence advantage, which we could leverage into an easy-to-use checklist that our client could begin working with immediately.

Avoiding any slowdown or confusion with such a time-pressured project was our priority. For us the answer was the personal approach of phone calls, not e-mails, and keeping everyone connected online for instant access to documents.

With so many possible requests for information, we created an in-depth document library, hosted on our cloud storage system. This was by far the most efficient way to keep the internal team working efficiently and to their full potential.

In the end, with just enough time for a mock inspection and a follow up review to ensure all information given was in compliance, we completed all preparations and the subsequent medic inspection was passed successfully.

Faster. Better. Smarter.

With Arriello’s faster, better, smarter approach, our client was best placed for success within just a month-long inspection timeline.

No one could predict the unexpected events that left only a few days to prepare, but our faster response and turnaround kept the team working efficiently  and effectively. Of course, being quick is only better when everything is planned, pre-checked and the gaps identified and closed (even if that was outside our initial scope). Our knowledge, intelligence and prior experience allowed us to predict our client needs and offer a smarter solution for success.

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