The COVID-19 pandemic forced countless companies to change the way they do business in order to continue operating while protecting employees and upholding their social responsibility to the community.
This includes drug and device sponsors, marketing authorization holders, and manufacturers who had to quickly adapt processes in order to maintain the supply chain for their critically needed products. Even in the face of a pandemic, organizations needed to perform GxP audits to verify compliance for processes and guidelines.
To qualify/re-qualify critical suppliers and vendors while complying with “stay at home” mandates and social distancing requirements — organizations turned to virtual audits as a solution.
If you are an organization looking to adapt your processes by utilizing virtual audits, we’ve created this resource to assist with your transition.
Virtual Audit Meaning
Virtual, also known as remote audits, are performed electronically, without the need for face-to-face interaction between an organization and the auditing party. All information is exchanged digitally rather than through paper forms. In some cases, these audits may require the use of live video streaming for conferences or even a walkthrough of facilities. Most activities in a virtual audit should be performed off-site, but some circumstances may require the auditor to visit the facility as well.
Virtual Audit Guidelines
Health authorities have provided guidelines to organizations, especially for clinical trials. For example, the FDA, as part of the Medical Device Single Audit Program (MDSAP), has provided some guidance for performance of virtual auditing (Document No. MDSAP AU P0036.001, Effective 13 Jan 2020) which is of course directly applicable to a Medical Device Audit, but the concepts are also very adaptable to Pharmaceutical/ biologic audits of API facilities, CMO’s, Supplier, and Vendor Audits.
EMA and MHRA also published several GxP guides with best practices in different topics for use during and after this COVID-19 pandemic period. If you’re wondering how to perform a virtual audit, start with these guidelines and tips:
Preparation for a Virtual Audit
- Preparation for a virtual audit is key to a successful outcome. Request information from the auditee to be submitted prior to the start of the virtual audit to fully prepare the auditor. This includes quality manuals, SOPs, org charts, etc.
- Ensure that data privacy requirements (HIPAA, GDPR) are met in accordance with audit processes.
- Gain understanding from the auditee on how records will be “pulled” and shared. It is understood that confidentiality and controlled distribution of documents is a concern for the audited firm, so file sharing with read-only access is important. There are numerous solutions, such as sharing documents electronically via Screen Share or by a file sharing system such as Box.com or SharePoint.
- Document sharing must comply with applicable global and local data privacy regulations. In case legislation prevents sharing of some essential data outside the auditee site, the scope of the audit can be adapted on a risk-based analysis to enable compliant business continuity and, if needed, complimentary evaluations can be scheduled to finalize the quality assurance assessment.
- Ensure at least one or two auditee personnel are dedicated to supporting the audit over the designated period.
- Ensure the technology for the virtual audit is agreed upon and tested. WebEx and Facetime are examples of available technology for tours and other options for video conferencing.
- Ensure web meeting invitations are sent with ample time for each party to plan conferencing and conference room space.
- Confirm the appropriate personnel are available and scheduled for the audit.
- Request a virtual tour be set up for a facility tour or detailed facility presentation by the auditee.
- Audit Plans and Agendas can be set up as normal.
- Time normally scheduled for a facility tour should be used to view an online virtual tour or presentation provided by the auditee in cases where a facility tour is mandatory. A risk-based assessment should also be applied to define the need of this facilities tour and/or which areas are essential to be covered if a complete tour is not feasible.
Performing the Virtual Audit
- Conduct the audit as closely as possible to an onsite audit.
- Audits can be split in two or more sections with intervals of a big enough duration for auditee to collect and upload documents requested during the audit in the pre-defined shared drive.
- Hold opening meetings with appropriate personnel using the video conferencing tool agreed upon.
- Request a virtual tour of the facility or that a facility overview presentation be provided with pictures, facilities plant and process flow (if applicable), following the opening meeting.
- If many of the documents and records are made available ahead of time by email or via a website service such as Box.com, then the auditor can proceed with document review.
- Questions and requests can be made via chat, email, phone, or online web conferencing.
- If the auditee does not make the documents available for the auditors’ review, then documents and records will need to be shown via the video conferencing tool being utilized.
Closing Meeting After the Virtual Audit
- The closing meeting should be held as normal but via the video conferencing tool selected.
- Ensure that this meeting has been planned and scheduled ahead of time with the proper invitees.
Pros and Cons of Virtual Audits
While initially organizations were forced to turn to virtual audits during the COVID-19 pandemic, many have realized the benefits of conducting these processes online. To help you determine if this makes sense for your organization, here are the benefits and drawbacks of conducting virtual audits:
- Cost savings from not having to travel, mail documents, store files
- Improved information transfer efficiency and accessibility through digital files
- Digital backups reduce risk of losing files
- Flexibility to complete the audit in blocks rather than a set number of on-site days
- Some audit processes may be more difficult to perform
- Training may be required to adopt new technology and processes
- Not all certification bodies currently accept virtual audits
- Concern of security through digitally transferred files
Get Assistance Conducting Virtual Audits
There is no doubt that performing an audit on-site has its advantages and allows the auditor to examine processes in real-time, conduct a physical tour of the facility, and observe visual cues and non-verbal communication with the audited firm. However, the COVID-19 crisis has forced companies to adapt and utilize other solutions. A virtual audit is an excellent solution to allow for business continuity and ensures that critical suppliers and vendors continue to function within a state of compliance as an extension of your firm. Even after the pandemic subsides, many organizations may continue to utilize virtual audits due to the associated benefits.
ProPharma Group can help you establish and maintain a common-sense, risk-based supplier management program while utilizing tools such as virtual auditing to fulfill your business continuity requirements. Contact us to get started today!
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