COVID-19 pandemic influences our way of working
The current COVID-19 pandemic has forced almost all companies to change their way of working, also ours. On the one hand we have a social responsibility towards our employees to protect their health, and on the other hand we have a business responsibility to keep our business going and to offer the best service to our customers, constantly being in compliance with quality expectations and GxP regulations. The compliance with processes and guidelines should be verified also in these times. The question now is “How does a company demonstrate performing GxP analysis while complying with employees working from home and physical distancing requirements which prevent them as well as the auditors from performing on-site audits?” Spectral Service will offer remote audits soon!
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 are preparing ourselves for a virtual/remote audit
The key of a successful audit outcome is the preparation. Thus, we from Spectral Service are planning the first steps towards the first virtual audit. How do we do that? We will participate 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 are presented. Thus, this information completes our long-standing knowledge of on-site audits.
What are our next steps?
As a next step, we implement our new knowledge of remote audits in a new audit homepage which will be launched soon. After arranging a virtual audit, our customers have the chance to login on our new homepage and to make a virtual tour through our laboratory being presented in 360° pictures, known from Google Street View. Furthermore, SOPs and other important documents will be offered here in a library simplifying the work of the auditor. We look forward to the feedback from our customers and also respond to their requests to establish a beneficial audit.
Spectral Service – continuously innovating!
Spectral Service is well known for its innovation drive. We continuously develop new methods, publish scientific papers, optimize our processes, forward the digitalization. The COVID-19 pandemic showed us how fast we must change our work and how fast it was possible for us. We are used to be flexible, which was our benefit during these times. Thus, we are very proud and pleased, that we have been having the opportunity to support all our long-standing and new customers by performing quality control on their samples. Do you need any support in the NMR analysis of your samples? Feel free to contact us!