Remote & Desktop Auditing.
Expert audit solutions at a distance.

What are Remote & Desktop Auditing?

Remote & Desktop Auditing are not the same thing but offer alternatives to in-person and on-site audits and the preparation for them. The use of Remote Auditing has accelerated by necessity from the impact of COVID-19, and the European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) agreed on a series of measures to mitigate the impact of disruptions caused by COVID-19 on the conduct of inspections of manufacturing facilities or other sites relevant for medicinal products in the European Union.

Having proven the worth and process, Remote Auditing has therefore become a mainstream option with potential benefits in the right circumstances.

Remote Audits.

With the right adjustments, remote audits can provide a virtual replication of in-person audits, but all processes and procedures must be reviewed as not all can be adapted to a remote model. Because of the physical site aspects of manufacturing and storage, GMP and GDP remote audits are less common, but certain provisions still exist.

If adaption and transition allow a remote audit to remain compliant, and feasible, then there can be significant benefits such as:

  • Improved efficiency and cost savings from eliminating travel.
  • Elimination of site security requirements, printing, etc.
  • Scheduling flexibility.
  • Wider geographical reach.
  • Faster learning.
  • Less admin through the use of technology.

Desktop Audits.

These are typically a subsection of remote audits, but can be standalone, where required documentation is verified remotely by an auditor. This can be with hard copies but is much more likely to be done with electronic media.

Click here for more information from the EMA on GCP Remote Auditing.

Click here for more information from the EMA on GVP Remote Auditing.

Click here for more information from the ECA on GMP Remote Auditing.

Click here for more information from the European Commission, HMA, and EMA on GMP/GDP Remote Compliance.

Why choose Aegisana for Remote & Desktop Auditing?

A smooth process.

Aegisana’s Compliance team is fully experienced with Remote & Desktop Auditing and can work with you to determine if your existing processes and procedures would be suitable and compliant for this procedure.

The key points to consider are:

  • Review and modify existing procedures to align with the remote audit framework, ensuring compliance with pharmacovigilance standards.
  • Assess scheduled audits to determine their suitability for remote adaptation.
  • Thoroughly review and update internal policies concerning document sharing through video calls and other communication channels.
  • Promptly communicate any modifications to auditees to facilitate their preparation for the audit.
  • Establish consensus on technology platforms for audit sessions and the exchange of relevant documents.

Success through planning.

Thorough preparation is essential for successful remote audits, which requires a clear project plan with well defined and communicated steps. We work with you to identify all the audit milestones, timelines, and methods of communication to make the process as easy and efficient as possible.

Our objective is to provide you with peace of mind and confidence that comes from knowing your processes are being handled by an expert team providing a meticulous and detailed service grounded in effective communication, reliability, and trust.

Through the establishment of a successful and robust strategic compliance partnership, we aim to offer comprehensive support across all our service areas, providing expert solutions throughout the entire life cycle of your human and animal products.

All of our services adhere to the regulations and principles of the EMA’s guidelines on compliance.