OR WAIT null SECS
Virtual audits proving to be beneficial post-COVID despite continuing challenges.
It is best practice for life sciences companies to audit their medical affairs (MA) functions at least every two years—whether those services are provided in-house or by a 3rd party vendor. Audit frequency is risk-based and typical industry standard for a vendor/supplier audit is 3-5 years. Regulations do not specify timeframes, only that an audit is required.
Prior to COVID-19, audits were mostly conducted in person. The pandemic forced companies to look for other ways to meet their audit obligations, and a virtual (remote) approach was generally seen as preferable to delaying the audit. When designed properly, companies found that virtual MA audits, conducted live, produced the same depth and breadth of observations as in-person audits. The virtual approach is now firmly established as a viable alternative, even with the easing of COVID restrictions.
There are some inherent challenges with virtual audits, most of which can be addressed during the planning process:
Planning is key to a successful virtual audit:
With both in-person and virtual audits, the requested documents are typically shared in a PDF format through a private secured network. If the audit is of a 3rd party vendor, the auditor’s access is read-only (no printing or downloading of documents) and is only for a limited time. This approach is convenient for the auditor, allows the auditee to control access, and is environmentally friendly.
Permanent storage of documents should be in a private, secured, and validated repository that utilizes file indexing and OCR (Optical Character Recognition) for the easy retrieval of documents.
The most notable advantage of virtual audits is that they save time and money. Conducting an audit virtually eliminates travel expenses and reduces the time auditors need to devote to the audit activities.
Even though audits can be effectively performed virtually, in-person audits are not a thing of the past. If the services are being provided in a location geographically close to the auditor, an on-site audit eliminates the challenges associated with virtual audits. A hybrid approach can also be taken—in which the bulk of the auditor’s document review takes place remotely, and a site meeting is held for questions and answers.
Alena Galante, director, quality and compliance, and Denise Dixon, global chief operating officer; both with Diligent Health Solutions