How to conduct remote audits successfully?

2021-06-02 11:42

PhaMe professionals performing remote audits

At Biocodex Nordics Pharmaceutical and Medical Services, PhaMe, we have been doing more pharmacovigilance audits remotely in recent years, especially since the Covid-19 outbreak. As a result, we have developed an efficient process for performing remote audits.

 

Remote audits in a pharmaceutical company

At Biocodex, we need to regularly audit a great number of suppliers worldwide, which can involve more time travelling than working on site. Whether in-person or online, the process is basically the same: reviewing all the relevant processes, personnel and documentation through a pre-audit questionnaire and interviews.

However, the decision to conduct an audit remotely is based on risk. Remote audits (through Teams) can be safer for some countries and are clearly more time-efficient and environmentally friendly. We will do more digitally in the future.

 

No better time to go digital!

Online audits are increasingly enabling auditors to avoid travel. “There’s no better time to go digital!” says Susanna Heinonen, Head of Pharmacoviligance.

Our certified auditors master different GxP areas. Our expertise encompasses, for example, pharmacovigilance, GMP, GDP and registration audits, mock audits in preparation for official audits as well as internal audits – anywhere in the world.

 

Interested in remote audits or other PhaMe services?

Please do not hesitate to contact Susanna Heinonen for more information.

Susanna Heinonen
Head of Pharmacovigilance (PV)
s.heinonen@biocodex.fi
+358 50 572 7896