In the wake of COVID-19, deploying remote audit techniques is rising in the Life Sciences industry. With the imposed travel restrictions across the globe, medical devices, biotech, pharmaceuticals, and other life sciences organizations are turning towards virtual or Remote audits. The remote audit is carried out by utilizing video conferencing auditor and auditee and other software/web applications.

Addressing specific client challenges in the audit and further delivering ideal solutions to remain compliant are the two (02) essential Regulatory audit objectives.

Remote Auditing with eQMS

When the remote audit is required for research, product development, and manufacturing facilities, engaging through web-based platforms may create minor technical chaos but on the other hand, moving to remote audit ensures the audit is conducted as per the schedule without fail and eliminates the need to visit vendor manufacturing facilities.

eQMS with a cloud-based infrastructure is the need of the hour and makes remote auditing a cakewalk without compromising on data security of sensitive and confidential information.

Remote Audit Transition and Best Possible Approaches:

  • Build a comprehensive agile plan to analyze the type of audit evidence and audit objectives.
  • Define technical requirements and possible risks, and decode the capabilities and limitations of different remote auditing tools.
  • Use controlled-access software for document sharing to protect the data.
  • Set validity to certain document access via secure VPN and network management.
  • Prepare for mock audits to understand necessary information and communication technology tools and make the interaction or video teleconferencing a smooth ride.
  • Evaluate possible vulnerabilities of the transition and leverage analytical assessments.
  • Choose the right vendor.

Are Remote Audits the Future?

The transformation is a never-ending process, and virtual dependency is the new normal with unforeseen circumstances.

The capabilities of remote audits comprise adaptability, flexibility, and increase in reach. With the customizable technology readily deployable, remote audit enables wider access and improves cost-efficiencies.

With growing online inspection strategies (at least for low-risk processes) in Life Sciences companies, it is beneficial for businesses to embrace remote audits and stay agile. Consult Freyr to know more about the compliance best practices.

 

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