Remote audits hold a list of advantages over traditional on-site methods including a reduction in scheduling, expenses and resource flexibility. Discover the
Benefits of
Remote Auditing
BACKGROUND

Process & Benefits
of Remote Auditing

FDAQRC works with clients and auditees to conduct quality activities by an experienced consultant in a timely and efficient manner. In some cases, the timing required for an audit, such as a GCP Investigator Site Audit, GxP Vendor Audit or Mock Inspection does not align with the auditees availability. In those cases, we are able to work with the auditee to perform audit activities remotely.

In these situations, our target is to perform remote audit activities with the same quality standards as an on-site audit with the additional benefit of overall cost reduction and increased flexibility in scheduling.

FDAQRC’s Project Managers and Consultants are experienced and able to support remotely conducted audits and our Quality Management System can also be used for remote GxP audits.

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BENEFITS
  • Overall reduction cost 
    • On-site audits typically require travel time and expenses which on average cost over $3000 USD per audit
  • More options of GxP consultants without additional travel costs
    • FDAQRC has 400+ global GxP consultants which can be fully utilized without travel costs when audits are conducted remotely
  • Flexibility in scheduling
  • Remote auditing provides the ability to conduct audits in situations where auditing on-site is a challenge
      • Geographic areas where travel is not recommended
      • Geographic areas where travel costs are exorbitant
      • In situations where health and safety of the auditee or consultant are a concern
CONSULSON

Remote audits hold a list of advantages over traditional on-site methods including a reduction in scheduling, expenses and resource flexibility. Challenges to remote audits are noted above. By working with FDAQRC, we ensure all options are carefully considered so our clients get the most out of their projects by utilizing our expertise and qualified resources.

"A remote audit was never considered until we discussed
this option with FDAQRC. FDAQRC assured us that it could be
conducted as efficiently as an on-site audit and would meet our
budget needs. In the end, we were completely satisfied with the
outcome and our vendor was as well.
GLOBAL QA DIRECTOR
EXAMPLES

Inspection Readiness

A client based in the US expected a regulatory inspection at one of their EU offices and wanted a Mock Inspection performed by a former FDA inspector. FDAQRC has more than 30 qualified ex-FDA inspectors and was able to meet this need. Since the company representatives were in US and Europe, careful consideration was made regarding time zones. The Mock Inspection was performed remotely and the activity was scheduled over one week with a core set of hours, which allowed staff from both US and Europe to participate. The consultant was able to effectively evaluate the inspection readiness of the organization and provide feedback from a former investigator’s perspective. The consultant was further retained for remote inspection readiness training.

Inspection Readiness

A client based in the US expected a regulatory inspection at one of their EU offices and wanted a Mock Inspection performed by a former FDA inspector. FDAQRC has more than 30 qualified ex-FDA inspectors and was able to meet this need. Since the company representatives were in US and Europe, careful consideration was made regarding time zones. The Mock Inspection was performed remotely and the activity was scheduled over one week with a core set of hours, which allowed staff from both US and Europe to participate. The consultant was able to effectively evaluate the inspection readiness of the organization and provide feedback from a former investigator’s perspective. The consultant was further retained for remote inspection readiness training.

Inspection Readiness

A client based in the US expected a regulatory inspection at one of their EU offices and wanted a Mock Inspection performed by a former FDA inspector. FDAQRC has more than 30 qualified ex-FDA inspectors and was able to meet this need. Since the company representatives were in US and Europe, careful consideration was made regarding time zones. The Mock Inspection was performed remotely and the activity was scheduled over one week with a core set of hours, which allowed staff from both US and Europe to participate. The consultant was able to effectively evaluate the inspection readiness of the organization and provide feedback from a former investigator’s perspective. The consultant was further retained for remote inspection readiness training.

$3,000
Cost Saving

During remote audits, the overall cost saving averages $3,000 USD.

1 Month
Time Saving

Approximately 1 month/30 days
of time will be saved during a remote audit.

Global
Support

Remote audits increase the
amount of auditors and resources available.

Flexible
Scheduling

Remote audits can be scheduled
to include the participation of people from disparate locations.

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