5 Ways Prepare for a Remote Audit

by | Feb 8, 2022 | Audits, Compliance, Consulting Group, QMS, Quality, Quality Systems, Regulatory, Standardization, Standards


A remote audit is a way of conducting an audit without being physically present. The overall goal is to evaluate and determine the extent to which the presented evidence complies with the audit criteria. While remote audits have become more prevalent in the past couple of years, they are still different than on-site audits and require different preparation.

  1. Technology Preparation: One of the most vital components of a virtual audit is technology. Ensuring the network has adequate bandwidth to support multiple people in an online meeting and that every participant is equipped with proper audio and video can help ensure the audit is not delayed due to technical issues. It is crucial that the auditor and auditee align with what platforms will be used for conferences and file sharing and then ensure that both parties are trained on how to use the determined platform.
  2. Team training and availability: All audit participants should be invited to meetings and can access the conference when needed. If there are scheduling conflicts, those should be discussed up-front and be minimized as much as possible.
  3. Agenda: As with on-site audits, remote audits require a detailed audit agenda and timetable shared with all participants. Although ad-hoc interviews are sometimes necessary, scheduling interviews in advance can reduce interruption.
  4. Auditor Access to the QMS: Most companies are not comfortable giving auditors access to their complete QMS, which is their prerogative. However, the auditor must be able to access the QMS documentation necessary for the audit scope, whether that is in files or through screen sharing.
  5. Documentation: This preparation may take the most time for a remote audit. All the necessary documentation must be ready to be shared on-screen on whatever platform was agreed to. If the auditee does not have an eQMS, this may mean scanning all relevant documentation into an electronic format for the auditor to review. Since scanning all documentation is incredibly time-consuming, it is essential to understand the scope of the audit. On the other hand, if you do not have a specific document scanned and the auditor asks for it, quickly finding, scanning, and uploading the document can be key in not delaying the audit. 

As the remote working capabilities increase and remote audits continue to follow suit, it is essential to prepare for them differently than an on-site audit. Remote audits are indispensable for all life science institutions that comply with specific regulations and standards. By utilizing modern technology, companies have the ability to conduct audits from anywhere. EMMA International routinely conducts audits, both on-site and remote. For help with auditing processes or preparing for an audit from a notified body, contact EMMA International by phone at 248-987-4497 or by email at info@emmainternational.com.

Alexis Ferrier

Alexis Ferrier

Alexis is a Technical Writer at EMMA International. She has research and development experience in both device and drug products. Additionally, Alexis has experience in quality assurance, quality control, regulatory requirements, and international compliance. She holds a Bachelor of Science in Chemistry from Michigan Technological University.

More Resources

FDA Adverse Event Reporting 

FDA Adverse Event Reporting 

When reporting an Adverse Event to the Food and Drug Administration (FDA) the best method is to utilize the FDA Adverse Event Reporting System (FAERS). FAERS is a database that contains adverse event reports, product quality complaints that led to an adverse event, and medication error reports1. All FAERS reports are easily accessible to the public. 
De Novo Classification

De Novo Classification

A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the device and there is not a previously legally marketed predicate device1. When determining if your device can go through the De Novo process there are two pathways available to determine the device classification.
Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.

Ready to learn more about working with us?

Pin It on Pinterest

Share This