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Interested in Pharmacovigilance Remote Auditing?

Updated: 5 days ago


Definition – PV Remote Audit

  • The conduct of a PV audit without physically being present on-site.

  • The audit may be conducted via telephone/teleconference, videoconference/WebEx.

Reasons for conducting PV Remote Audits

  • Pandemics, natural disasters at the audit location

  • Travel and security issues at the audit location

  • Remote vs. on-site approach selected for low risk parties as assessed during risk assessment of audit universe

  • Narrow audit scope not warranting an on-site visit

  • Obtaining information for risk management universe

How Zigzag can support you

Zigzag can support you by conducting PV Remote Audits. In addition Zigzag can support you with the development of audit questionnaires and assist with the preparations for PV Remote Audits.

Zigzag have experience in conducting PV Remote Audits of:

  • Affiliates / Local Operating Companies

  • Distributors

  • Market Research Agencies

  • Patient Support Programme Providers

  • And more!

Zigzag can also provide you with training on how to tackle this innovative auditing approach from sharing best practices to ensuring you meet regulatory compliance requirements when conducting audits remotely.

Information Sharing

Ejaz Butt, Associate Director of PV at Zigzag presented on the topic of PV Remote Auditing at the RQA West and Wales Regional Forum on 21st April 2016.

The topic raised some interesting discussion and highlighted the need for companies to adapt to handle the increasing demand for PV Remote Audits.

Contact Details

Contact us for more information via email: info@zigzagassociates.com or telephone: +44 (0)1235 854033

The above article was prepared by Zahra Khokher, PV Auditor/QA Manager.

To read this article on LinkedIn please follow the following link:

https://www.linkedin.com/pulse/pharmacovigilance-remote-auditing-zahra-khokher?trk=hp-feed-article-title-publish

#pv #quality #qualityassurance #qa #pharmacovigilance #audit #audi #remoteauditing #zigzag #zigzagassocaites #informationsharing #zahra #zahrakhokher #linkedin

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