FDA Releases New Draft Guidance for Remote Regulatory Assessments
RAPS Regulatory Focus reported last Friday that the US Food and Drug Administration (FDA) released draft guidance on July 22nd that formalizes its plans for using remote regulatory assessments (RRAs) for FDA-regulated products to supplement onsite inspections as we work our way out of pandemic protocols and codify “new-normal” modes of operation. The 17-page draft […]
After a Global Pandemic, Are Fully Remote QMS Audits Truly Effective?
Although ISO 19011—“Guidelines for auditing management systems” has included language about remote QMS audits since the 2018 revision, this became a reality for many of us in March 2020 with the onset of Covid-19 and the mass lockdowns that ensued. Many of us have been exclusively auditing quality management systems remotely for a year and […]
A Registrar’s Perspective on the Effectiveness of Remote QMS Auditing
We’ve written extensively about remote auditing in the wake of nearly two years of the pandemic, but primarily from the perspective of an auditor or a client organization. Watch the video from Quality Digest as they interview Paul Butcher, CEO of LRQA, to get some insight on remote auditing from a registrar’s perspective.