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Drug companies are continuously striving to reduce and streamline clinical drug development. However, with the current pandemic precautions, increasing pressures to reduce climate impact, political unrest in some geographical regions and continued pressure from Regulatory Authorities to maintain or increase oversight of all clinical research activities, one of the areas which could potentially be a solution is the consideration and increased use of remote audits instead of on-site audits. As such, this area has been a topic of great interest among the auditing and regulatory community for a number of years.
Standard auditing is traditionally carried out with the auditor located in-situ in order to review documentation and conduct face to face interviews. However, as technology capabilities have significantly increased in the last 10 years with the development of data clouds, secure portals and virtual networks, the plausibility and feasibility of conducting remote audits has also changed significantly and continues to change with technological advances in accessibility, control and security.
But how feasible are remote audits in the context of GxP regulatory requirements and expectations? What are the risks and logistics which need to be considered before deciding whether to choose a remote audits vs an on-site audit? Is a remote audit sufficient to meet the requirements of the regulatory authorities’ expectations?
Like everything in the world of clinical research, the risks, plausibility, feasibility and benefits must be considered carefully before selecting a remote audit versus a traditional style on-site audit.
Some of the initial considerations should be:
Who or what is to be audited and the significance of the audit? i.e. routine, for-cause, qualification, re qualification etc.
What is the type of data, documentation, service or area that is to be audited?
What are all the risks associated with conducting on-site vs remote in terms of patient safety, scientific integrity of the data, process integrity/quality of service, business reputation or risk of legal action?
What are the realistic logistical challenges faced when conducting a remote audit and can they be overcome or managed within the risk assessment allowances?
What are the true costs and time benefits associated with a remote audit?
If fraud or misconduct is identified or suspected during the remote audit, what plausible risk mitigation steps can be implemented from a remote location without risk of further data integrity or patient safety issues from occurring?
So, after asking and assessing the answers, are remote audits feasible?
We believe so and, at Zigzag, we have extensive expertise, experience and knowledge of conducting a huge variety of both remote and on-site audits from pre-clinical drug development through to post marketing surveillance activities in compliance with global GxP regulatory requirements. As such, we would like to provide expert knowledge and guidance to your company when assessing when and if remote vs on-site audits are appropriate and achievable whilst not compromising quality and regulatory compliance. Why not reach out and ask for the help?
The above article was prepared by Gael Love, Senior QA Manager.