The Medical Device Single Audit Program (MDSAP) has been a blessing for many medical device manufacturers because it has allowed third-party auditors to conduct a single audit of a medical device company to satisfy the regulatory requirements of the five countries participating in MDSAP – the US, Canada, Australia, Japan and Brazil. However, the ongoing COVID-19 pandemic has disrupted the global medical device industry just as it has disrupted so many other industries. As a result, conducting onsite MDSAP audits of manufacturing facilities has become especially troublesome and, like so many others, the medical device industry has shifted auditing tasks to a virtual environment.
When remote auditing is the only option, video conferencing platforms like Zoom and Skype have proved to be just as helpful in the regulation of medical device manufacturing as they have been for a huge number of other industries during the global pandemic. To address this fundamental shift to virtual auditing activities, FDA has issued a guideline with the lengthy title: Extension and Expansion of Temporary extraordinary measures related to MDSAP audits during covid-19 quarantine orders and travel restrictions – Remote audits.
In this document, the agency has outlined what it terms “interim extraordinary measures” to be taken while the pandemic continues to have an impact on onsite auditing activities. While these are in effect, audit organizations (AOs) are requested to:
- Identify affected facilities at which timely surveillance and recertification audits cannot be completed in accordance with the audit program, and
- obtain information about the status of the facility, its operations, and quality management system
- evaluate the past conformity of the facility
- evaluate the possibility of performing a remote audit of the facility
- evaluate the risk of maintaining or renewing certification in the absence of an onsite audit
- establish a plan for resuming regular oversight activities
- Keep records of the identified facilities and their corresponding evaluations
- Provide copies of policies, procedures and work instructions for the performance of remote audits
- Limit remote audits to surveillance, recertification audits, significant change audits without any extension of the scope of certification, and transfers between AOs (Initial Stage 2, special, and unannounced audits cannot be performed off-site under these measures)
- Regulatory authorities (RAs) reserve the right to witness remote audits
Medical device manufacturers are considered eligible for remote audits if, in general, they have a good record of conformity. Under certain circumstances, companies can also use remote audits to transfer facilities between AOs. However, facilities that have a high number of nonconformities, require an onsite verification of implemented corrective actions, or are in need of an extraordinary or unannounced audit are not eligible.
To learn more about the use of remote audits during the pandemic and to obtain a copy of the complete interim FDA MDSAP remote audit guidelines, contact the MDSAP experts here at MEDIcept.
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MEDIcept is an international consulting firm offering a full portfolio of services to the medical device and IVD industry. For over 25 years, our unique consulting practice and multidisciplinary team of former FDA, Notified Body, and industry experts have assisted hundreds of companies of all sizes with innovative, compliant, trusted, and cost-effective Regulatory, Quality, Clinical, and Engineering solutions.
For additional information, please contact Susan Reilly at SReilly@MEDIcept.com.