What Is A Pharmacovigilance Audit?An audit is a systematic, disciplined, independent and documented process for obtaining evidence and evaluating the evidence objectively to determine the extent to which the audit criteria are fulfilled, contributing to the improvement of risk management, control and governance processes.
Can Remote Audits Really Reduce Costs?Many MAHs have multiple third parties and local sites responsible for providing safety data that feeds into the global safety database for their product. Performing on-site PV Audits of all these stakeholders can be logistically difficult (e.g. in high risk geographical areas) and financially prohibitive for small MAHs. So, how do MAHs fulfil their legal and regulatory obligations to audit and to maintain QPPV oversight of all stakeholders spread across the globe? One answer may lie in the performance of a remote audit. They are otherwise known as;
- an online audit,
- desktop audit,
- virtual audit,
- or web-based audit.
- audits of parties who perform non-critical low-risk processes,
- for routinely required repeat audits where previous (on-site) audit identified no critical or major findings,
- for auditees with no major changes since the last audit (organisational structure, regulatory framework, facilities, processes, delegated activities).
What Are The Negatives Associated with Remote Audits?There are, of course, negatives to not being on-site when performing an audit. Remote audits are (e.g.) not suitable for facility audits, as a walk-through of the site identifies issues that would be missed in a remote audit. It is also more difficult to follow up issues identified during a remote audit and reliance on communication tools (e.g. wifi) is paramount and can be problematic.
Points To Remember When Preparing a Remote Audit:
- The audit flow should be the same as an on-site audit
- Facilities “tour” should be agreed in advance (e.g. photos, plans, live feed)
- An Opening and Closing meeting should be included in the Agenda
- Request documents for review to be provided in advance (e.g. into a Dropbox) of remote audit Attendance form to be completed for those in attendance at the remote site
- Test the webinar/communication tool in advance (including screen-sharing)!
- Back-up arrangements to be defined and tested
- Allow some time during the remote audit to review evidence – this may necessitate delaying the closeout meeting until all evidence has been reviewed
What Should You Do During A Remote Audit?
- Make sure that information is correctly conveyed – in both directions
- Be clear on when document requests are expected (e.g. immediate or within 24 hours)
- Make sure that the QMS covers the performance of Remote Audits