In accordance with GVP Module I, the MAH is responsible for performing risk-based audits of the quality system at regular intervals including audit of the PV system. The methods and conduct of these audits are outlined in GVP Module IV.
In general, 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. 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, otherwise known as; an online audit, desktop audit, virtual audit or web-based audit. These can be conducted remotely via telephone, teleconference, videoconference or other analogous tools (e.g. WebEx, Lync, DropBox, Skype etc). When remote audits are routinely performed by an MAH – these will need to be documented, together with the risk criteria and rationale – as part of the MAH’s Audit Programme.
Examples where remote audits may be an acceptable option include: audits of parties who perform non-critical low-risk processes, for routinely required repeat audits where previous (on-site) audit identified 0 critical or major findings, for auditees with no major changes since last audit (organisational structure, regulatory framework, facilities, processes, delegated activities). 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 which 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 provide 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 close out meeting until all evidence has been reviewed
During the 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
In conclusion remote-audits may not be appropriate for all sites, and are not a replacement where on-site audits are expected (e.g. for previously identified high risk 3rd parties). But, provided the auditor has the vital collaboration of the auditees – remote audits can be used as a useful tool for ensuring low-risk 3rd parties are audited as part of the MAH’s obligation to maintain QPPV oversight and PV compliance of the overall PV System.
If you would like to chat to us about conducting a remote or on-site audit of your pharmacovigilance systems then complete your details below and we will get back to you. Alternately, you can call us on 00353 52 61 76 706.