Virtual Audit


Virtual Audit is Ideal in Economically Challenging Times

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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Additional Articles on Virtual Audits

This article was first published in the July 2012 edition of Quasar, the membership magazine of BARQA (British Association of Research Quality Assurance).

Remote Audit: Out of Sight but Not Out of Mind

Virtual Audit in Regulated Industries

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.

When Virtual Audit is Helpful

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):

  • If you have prospective customers from other states or overseas who are evaluating your products and services, they may ask for an audit before they make their final decision. You may offer virtual audit as an option to help them save time and money on travel.
  • If you have existing customers that require periodic audits, virtual audit is a viable option for follow-up audits. If additional information is needed, you may set up a video conference.
  • If your company has to conduct internal quality audit and you have facilities in other cities, states, or countries, virtual audit will help save considerable time and money.

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.

Using MasterControl for Virtual Audit

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:

  • Automates and Streamlines Quality Processes: MasterControl automates all quality processes, making it easier to manage them. MasterControl is widely used as an enterprise wide quality management system and a platform for all compliance efforts. Using MasterControl will facilitate a virtual audit process.
  • Increased Efficiency: MasterControl eliminates the bulk of the legwork associated with planning and scheduling an audit, including task assignment, follow-up, review, and approval of audit-related documents. All audit tasks can be planned and scheduled well ahead of time.
  • Single Repository: MasterControl provides a single web-based repository where audit-related and all other quality documents will reside securely, making it easy to search, track, and retrieve documents during on-site or virtual audit.
  • Provides Connectivity: MasterControl connects the audit process - whether on-site or virtual audit - with document control, CAPA, change control, training management and all the other quality processes that impact product quality and compliance. Audit Workspace: MasterControl provides workspace, in which the audit team can effectively manage all information about every audit. The workspace makes it easier to gather information during the audit process. All of these things are essential for a smooth virtual audit or on-site audit process.

Contact Us About Virtual Audit

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.