Conducting Audits at a Social Distance


Over the past several months, people across the globe have made adjustments to aspects of their everyday lives that they likely gave little thought to before the COVID-19 pandemic. In the industrial world, social distancing has put organizations to the test in terms of their ability to function and conduct business virtually with a geographically dispersed workforce.

Overall, companies in most industries have been able to adapt and continue operating with employees working remotely. However, there are still some elements of business operations that are best handled up close and personal — like audits. It’s a little difficult to carry out these activities when everyone is essentially told to stay put. Fortunately, technology has stepped up and made it possible to conduct audits remotely.

On-Site vs. Remote Audits

On-site visits during audit proceedings are usually necessary to allow inspectors to tour the facility and observe:

  • Actual production areas and processes to ensure they are in compliance.
  • Personnel demonstrating their skills and qualifications to perform their job functions.
  • That all reporting tasks are accurate and properly completed at each workstation.
  • That all production equipment is maintained according to regulatory guidelines.

While it’s usually common for companies to host an in-person inspection, there are times like right now when it makes more sense to perform audit proceedings from a remote location. For instance, if auditors have already visited a facility multiple times, a site tour might not be necessary. However, an auditor still might need to check out specific areas of a facility and interview employees. These inspections can be conducted virtually with video conferencing technology. Someone can walk through the facility with a remote device and transmit photos of specific items for a more detailed review.

Digitization is Key to Successful Remote Audits

Developing regulated products involves attention to detail — and a considerable amount of documentation. During an audit, inspectors need to review and qualify various types of documents, including quality manuals, standard operating procedures (SOPs), nonconformance logs, deviation records, material safety data sheets (MSDS), the list goes on. Audits go much smoother when you maintain up-to-date, accurate and error-free documentation that’s easy to locate as needed.

If all documents are in electronic format, the audit can be relatively easy. However, remote audits are not practical for companies using paper-based processes. To prepare for an audit, these companies need to scan volumes of documents to store them electronically. Then they need to set up a storage and file naming system in order to locate specific documents as needed. This method of document management presents several challenges:

  • Scanning is extremely time consuming and not an optimal use of resources.
  • Individual pages can get lost.
  • Scanned documents might be poor quality and difficult to read.
  • Every staff member involved in document control might have a different file naming method.

The inherent challenges with managing numerous and varying types of documentation include errors, delayed or stalled approval processes, incorrect versions in circulation, missing dates, lost documents, etc.

A digitized document management system alleviates document management hurdles:

  • Maintain documents in centralized location with a consistent file naming method.
  • Immediately locate and retrieve specific documents, including supporting documentation and document status information anytime, from anywhere.
  • Allow relevant stakeholders and auditors to securely access and review documents simultaneously regardless of geographical location.
  • Integrate document control with all other quality processes such as training, change control, corrective and preventive action (CAPA), supplier management and audits.

Digitizing document management tasks improves overall efficiency, audit performance and the ability to achieve compliance faster.

Despite the unprecedented and uncertain circumstances with the global pandemic, regulated companies are adapting to a new way of conducting audits. Whether you’re doing remote or on-site audits, digitizing document management automates your document management and all other quality-related processes, which significantly improves your compliance efforts.


David Jensen is a content marketing specialist at MasterControl, where he is responsible for researching and writing content for web pages, white papers, brochures, emails, blog posts, presentation materials and social media. He has over 25 years of experience producing instructional, marketing and public relations content for various technology-related industries and audiences. Jensen writes extensively about cybersecurity, data integrity, cloud computing and medical device manufacturing. He has published articles in various industry publications such as Medical Product Outsourcing (MPO) and Bio Utah. Jensen holds a bachelor’s degree in communications from Weber State University and a master’s degree in professional communication from Westminster College.

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