In life science and other regulated environments, audit is necessary to comply with regulations and to ensure the quality of products. Regulated companies not only need audits - they need frequent audits. However, in these economically challenging times, frequent on-site audits can be costly. Fortunately, there is such a thing as "virtual audit"- conducting an audit without being physically present at the facility under audit.
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This article was first published in the July 2012 edition of Quasar, the membership magazine of BARQA (British Association of Research Quality Assurance).
Regulated companies conduct and also undergo any or all of these types of audits: first-party audit, second-party audit, and third-party audit. When is virtual audit appropriate?
Third-party audits, which are conducted by regulatory agencies or independent bodies, are generally not done remotely. Inspectors not only want to review documents, but may require a physical inspection of the company's systems, facilities, and equipment; in some cases, inspectors may want to observe personnel performance.
Virtual audit is generally considered more suitable for first-party audits (conducted internally by a company) and second-party audits (conducted by a customer) that involve low-risk processes.
If your company is regulated, you must remember that not all audits are created equal. Therefore, not all audits can or should be performed remotely. Virtual audit should be based on risk.
Virtual audit is helpful in the following situations (again, it has to be based on risk):
While virtual audit is great for the situations mentioned above, it is only effective if both the auditee and the auditor utilize an electronic document management system (EDMS). One of the biggest advantages of an EDMS is that it can offer secure links that will limit the auditor's access to the system, so you can rest assured that only relevant information will be shown to the auditor. Is it possible to conduct a virtual audit without an EDMS? Perhaps, but not as easily.
MasterControl quality and compliance software is a fully integrated web-based solution that provides an electronic platform for all quality processes. It automates and streamlines not only the document control and change control processes, but all other quality processes, including audit management, training control, CAPA, and nonconformance management.
MasterControl Audit™, an integrated component of MasterControl software, automates, streamlines, and manages the audit process - from preparation all the way to completion. MasterControl makes virtual audit a viable and cost-effective option for low-risk follow-up and regular audits. Here are some of the benefits of using the MasterControl system:
Whether you are looking to learn more about virtual audit or our exceptional products and services, MasterControl's team of experts is on hand to answer your questions. To learn more about implementing an audit software solution, call us toll free at 800-825-9117 or contact MasterControl online.