COVID-19 pandemic influences our way of working
The current COVID-19 pandemic has influenced every company, including ours, to modify their processes, and to accelerate the digitalization. On the one hand, we have a social responsibility to preserve our employees‘ health. On the other hand, we have a business obligation to keep our company running and provide the best service possible to our clients, while always adhering to quality standards and GxP regulations. In these times, it is also necessary to verify the compliance with processes, guidelines, protocols, and norms. However, how does a corporation demonstrate performing GxP analysis while complying with employees working from home and physical distancing rules that preclude them, as well as the auditors, from conducting on-site audits?
ISO, IAF, EMA, MHRA and FDA
Authorities like International Organization for Standardization (ISO), International Accreditation Forum (IAF), European Medicines Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA) and U. S. Food and Drug Administration (FDA) have started right after the beginning of the pandemic to work on guidelines for performance of GxP practices and virtual/remote auditing during this COVID-19 pandemic period.
We from Spectral Service offer virtual/remote audit
From our point of view, the key to a successful future is the digitalization. Thus, we from Spectral Service went the first steps towards the first virtual audit. How do we do that? We participated in the online workshop “Remote Audit and Inspection” offered by Concept Heidelberg in July 2020. Within this workshop topics like legal fundamentals, methods and tools, preparation, and performance, as well as communication and examples for the practical implementation were presented, which completed our long-standing knowledge of on-site audits.
Our remote audits
Since March 2020 we have organized several remote audits where our international customers received the opportunity to take a look at our company, processes, QA system and reports. Therefore, we provide documents in advance, and use a combination of MS Teams and live recording of the laboratories.