AssurX Blog
Straight talk for regulated industries.
5 Quality Management Trends to Watch in 2021
2020 represented the sharpest economic slowdown in modern history. Nonetheless, with manufacturing orders reaching a three-year high in February 2021, according to the Institute of Sup [...]
Computer Systems Assurance: Making the Transition from Computer Systems Validation
For decades, pharmaceutical and medical device companies have operated under the assumption that they must document and validate each and every software used in their processes. The co [...]
Automating Asset Change Management for NERC CIP-010 R1: Webinar
View our one-hour on demand webinar focused on the challenges of implementing a well-constructed NERC CIP-010 Asset Change Management system and how automation helps knock down hurdles [...]
Remote Audits in the Age of COVID-19
Amid the ongoing pandemic, groups like the European Commission (EC) and the International Accreditation Forum (IAF) have announced notified bodies (NBs) can conduct remote audits for k [...]
AssurX Webinar – EU MDR Preparedness: Implementing a MIR-Ready Complaint Management Solution
Join us for a one-hour webinar focused on efficient management of postmarket challenges faced by medical device manufacturers marketing devices in the EU. DATE: Tuesday, [...]
EQMS Implementation: How to Lead Organizational Change
The Kübler-Ross Change Curve®, adapted from the original five stages of grief (originally published in 1969), has been expanded to reflect a highly applicable curve for adapting to any [...]
