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August 3, 2020 Life Science Consulting

Virtual GCP Auditing: Your Questions Answered!

James Meckstroth Associate Director, Clinical Services

How quickly the auditing landscape has changed! Less than one year ago if ProPharma Group were asked to perform a clinical audit on your firm’s behalf, we would reply with “when, what, and where?” Today when asked, we reply “when, what, and how (virtual or onsite)?”

Despite many of the world’s allowances and activities being paused in response to the COVID-19 pandemic, the requirements for self-check and monitoring oversight of our regulated industry have not changed. Clinical service providers and Sponsors are still responsible for ensuring that Protocol and Patient/Subject Safety requirements are met during the performance of clinical studies, that drugs meet quality and efficacy standards, and supporting vendor and service providers are operating within a state of compliance. During this pandemic, there is no pause in maintaining compliance.

Now that government regulatory authorities are performing virtual inspections themselves, the practice of virtual audits has become much more widely accepted.

From a clinical audit process structure and approach methodology perspective, there is very little difference between virtual and onsite auditing. In both cases Subject Matter Experts (SMEs) are engaged, audit scopes are identified, audit plans are prepared, and the audit itself is conducted with real-time involvement between the auditor and the auditee.

Which assessments can be done remotely?

We have observed that virtual auditing may be applied to all types of clinical audits:

  • Investigator Site (with some limitations in EU)
  • Contract Research Organizations (CRO)
  • Case Study Reports (CSR)
  • Trial Master Files (TMF)
  • Mock Clinical Inspection
  • Pharmacovigilance (PV)
  • Clinical Packaging
  • Contract Manufacturing Organizations (CMO)
  • Sponsor Internal Clinical Quality Management Systems (QMS)
  • … and more

Are there any limitations?

With a growing number of smaller startup venture companies who operate most of their business virtually already, this is a simple step in a similar direction. Understandably, there are a few limitations with a virtual audit compared to an onsite audit, with the site tour being the most notable. Whereas the use of webcams and live video streaming may provide a close substitute, there is something to be said about the ability to be able to look at all angles of a room or process in person, as well as being able to use all your senses.

Some ways to help mitigate this limitation is to allow for the tour to be interactive, ask for camera panning and 360° turning for full room view, and follow the tour route along with a site floor diagram to help ensure that no critical areas are skipped. Also, do not hesitate to request that the virtual tour guide backtrack or move in for a closer look at labeling, forms, logs, computer screens, etc. We have also performed virtual/onsite hybrid audits where the bulk of the document and data review is conducted virtually and a brief or limited party onsite tour is performed simultaneously or at another date.

How is privacy secured?

Data privacy and patient confidentiality are a concern that requires evaluation and consideration as well. Whether it is patient data, trial subject blinding, or client confidential information, protecting and maintaining secure data transfer is understandably vital. Some strategies that we apply to address this concern are the use of nondisclosure or confidentiality agreements (NDA/CDA) and limited read-only access to secure files.  Screen-sharing with an authorized individual (e.g., Clinical Research Associate) who navigates the data pages while the auditor observes, which is equivalent to “looking over the shoulder” during an inspection, is another approach to addressing data privacy and confidentiality.

Depending on the ability of the auditee to virtually host an audit, it may be necessary to perform the audit on-site. In these cases, ProPharma Group has used our global network of local consultants to meet audit needs regionally, without facing travel restrictions.

What are the benefits of virtual auditing?

Alongside the limitations and concerns, there are many benefits to virtual auditing that deserve to be highlighted:

  • Maintaining Compliance during times of social distancing: Companies can adhere to regulations, protocol directives, and procedural mandates while remaining compliant with local social distancing mandates.
  • Budget saving: Virtual auditing is more cost efficient. Without the necessity for travel costs, which can account for half of the cost of an audit, a company’s audit budget may be cut in half.
  • Flexible timing: Scheduling is more open, Mondays and Fridays now become viable audit days, whereas these are typically reserved for travel days for in-person onsite audits.
  • Resource options: Broader choices for use of SMEs since geographic limitations do not impact the auditor or auditee for virtual audits.

How should I prepare for a virtual audit?

In a shift to virtual auditing earlier this year, we quickly identified that a crucial aspect for virtual clinical auditing success is the additional effort of careful upfront preparation and planning. More attention should be given to outline the audit plan and identify source documents that the auditor plans to request to ensure that site SMEs and documents will be ready and available.

Adding to our virtual auditing success, ProPharma Group is very flexible with technology. Prior to the audit we work with the auditee to define which connection tools will be used for each topic listed in the agenda (e.g., interviews, site tour, opening and closing meetings). We found that most auditees wish to establish and control their own digital platforms for access to their documents and interface with their SMEs. Therefore, we like to first hear what the auditee recommends is best for their site. If necessary, we perform a pre-audit test of these connection tools. Lastly, and not to be overlooked, we establish a contingency plan in case any IT issues occur during the audit, this way unforeseen technology snags can be quickly addressed.

By appreciating the limitations, concerns, and benefits of virtual clinical auditing, ProPharma Group can adapt swiftly to the new landscape and make the transition to conducting many of our audits virtually. This immediate conversion to virtual auditing has caused no delay in meeting our clients auditing commitments.

For more information on preparing a virtual audit, check out our article on Top Tips for a Successful Virtual Audit During COVID-19.

In addition to auditing, our Clinical Quality consultants have extensive technical writing and operational experience to support your organization’s clinical needs. Additionally, our wide array of regulatory and compliance services includes vendor qualification audits, mock regulatory inspections, gap analyses, Medical Monitoring and DSMB support, quality management system development and optimization, and interim quality management.

Contact us to discuss ways we can partner with you. Just let us know “when, what, and how” you would like your audit!

About the Authors:

James Meckstroth

Associate Director, Clinical Services

James Meckstroth has worked for ProPharma Group since 2014 and is responsible for managing Life Science Consulting’s Clinical Services. This division includes Clinical Auditing, Clinical QMS, Medical Monitoring physicians, and Data and Safety Monitoring Boards (DSMB). He is also responsible for supporting ProPharma Group's global Quality Systems division on compliance related projects, providing consulting and contract services to clients for a range of Quality related regulatory GMP and GCP topics.

 

James’ academic background includes a bachelor’s degree in Microbiology and a master’s degree in Business Administration. He has 20 years of experience working in FDA regulated Quality Assurance/Control industry. He launched his career with food and life science companies working in chemistry and microbiology laboratories, before moving into GMP pharmaceutical Quality Assurance and Quality Control Senior Management at a fast-paced Contract Manufacturing Organization.

 

James draws from his diverse quality background and applies it, with a demonstrated passion for quality, to the completion of projects. He is driven to ensure that internal and external client expectations are met. James leads by example and exhibits a “do as I do” philosophy, always eager to assist.

 

Outside of work James enjoys spending time with his wife and two kids, hiking, fishing, and other leisurely outdoor activities, as well as tackling the occasional home renovation.



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