BioPharm International - May 2021

BioPharm - Partnerships for Outsourcing - May 2021

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24 BioPharm International eBook May 2021 Succeeding with Remote Audits Preparation is key for remote vendor and contract partner audits, early adopters say. W hen COV ID-19 forced the life sci- ences industry to pivot to remote work models, many organizations had to quick ly assess and restructure their audit programs to ensure business con- tinuit y without compromising qualit y and compliance. They turned to technology such as videoconferencing, col- laboration solutions, and streaming video to replicate—to the greatest extent possible—the rigor of an onsite audit. However, the sudden shift to remote auditing a lso brought many challenges, including the need to revise poli- cies and governing documents; procure and implement new tools and technology; and introduce organizational change management to help personnel adjust to new processes. In April 2021, FDA issued guidance on use of remote technology to supplement on-site inspections for reviews and assessment (1). Use of remote technology had been accepted by other regulatory agencies in 2020. LEVERAGING BEST PRACTICES In a recent panel discussion (2), quality experts from Merck & Co. and GlaxoSmithKline (GSK) shared their learnings, best practices, and tips for successfully conducting remote audits, offering recommendations about the scope of an audit, plan- ning strategies, scheduling, and the need for practice sessions. Ralph Mazenko, executive director of Merck Research Laboratories' clinical quality assurance (QA), indicated that the biggest change for his organization was exploring the scope of a remote audit. "We found that we could achieve an acceptable level of rigor and risk when we look at multiple locations instead of one," he said in the panel discussion. "For example, we can remotely audit processes and systems asso- ciated with investigational medicinal product (IMP) storage and disposition for multiple locations instead of auditing only one location onsite." MIKE KAWANO is director of Vault Quality at Veeva Systems. MIKE KAWAN Partnerships for Outsourcing Quality/Regulations ROBERT KNESCHKE - STOCK.ADOBE.COM

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