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 O

The below article was written for this blog by QA Manager, Zahra Khokher and our Associate Director of PV, Ejaz Butt. SOP Writing, Gap Analysis & Inspection Readines Background In the pharmaceutical industry, it is very important that a MAH has documented procedures in place in accordance with the regulatory requirements. This is a critical requirement in pharmacovigilance (PV) where patient safety is at risk if compliant procedures are not in place. From adverse event case m