Since clinical trials are extraordinarily expensive and addendum to ICH GCP E6 R2 recommends to “encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting”, as well as to use risk-based approach when planning the activities in clinical trials, industry must move forward and utilize efficient procedures in any possible area. One of the ways to optimize is through shared audits.
A shared audit is an audit, conducted by several companies at one time through an independent auditing company.
- Shared audit means shared costs.
- Shared audit saves effort and time – you don’t have to send your QA person, break working processes and try to fit in another audit.
- As an addition to the previous one, a shared audit saves money on travel costs.
- You can share an audit with any regulatory similar company – for example, works perfectly for the EU and the USA. It doesn’t even have to be only two companies – the number of participants is limited by you. By adding more participants, you save more money on the cost of the whole process.
- Shared audits are no different from standard audits from a regulatory point of view, so there are no problems with further processing of its results. Remember the quote from the ICH in the first paragraph? Share audits are a perfect fit.
- You can share not only an existing vendor audit but also a new vendor qualification.
And here’s a piece of experience:
Last year we had our first shared audit.
In our case, it was two of our clients, both EU based, so regulatory similar. Before the actual audit started, both clients agreed on a contractor – independent auditing company, and an audit plan, based on their needs and requirements. As a vendor and the audit subject, Flex Databases received and used two audit plans: with similar content but separated to provide to every participant of the process. The audit took three full days, the process went smoothly, and the same way dozens of previous audits went.
After the audit, we’ve received two reports, that were reviewed by participating companies in accordance with their own requirements. And we’ll boast a little here – we got only a few corrections and comments. After we’ve implemented corrective and preventive actions, the process for us was complete.
If you want to know more about our experience with shared audits from a vendor perspective – send us a message to firstname.lastname@example.org.
If you’re looking for a new eClinical solutions vendor – here we are, audit and questions ready. Request a demo via the button on top of the page or drop us an email to email@example.com.