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Clear, actionable intelligence for regulated industries.
Expert perspectives that simplify complexity and support stronger quality and compliance outcomes.
New FDA Traceability Rules Coming: What the Food & Beverage Industry Needs to Know
In FDA-regulated industries, a single event can lead to widespread change. For example, the 1982 tragedy involving Tylenol laced with potassium cyanide changed the way we look at produ [...]
AssurX and Rokster Partner to Help Utility Companies Realize Long-Term Cybersecurity Management and Compliance Goals
Expert consulting knowledge and industry-leading cybersecurity management software provide the ultimate solution to minimize risk of cyberattacks and regulatory fines MORGAN HILL, CA [...]
Root Cause Analysis and CAPA: Creating a Closed-Loop Process
This article examines why a closed-loop root cause analysis (RCA) and corrective and preventive action (CAPA) process is critical, as well as the key steps it should cover. In addition [...]
AssurX Announces Migration to Switch for Cloud-Based QMS and Compliance Platforms
Powerful Private Cloud Delivers Enterprise Performance and Security MORGAN HILL, CA, USA, August 19, 2021 /-- AssurX, Inc. (AssurX), a leader in quality management and regulatory compl [...]
How to Automate Food and Beverage Quality Management
Data buried in file cabinets. Forgotten emails. Poorly documented processes. Unfortunately, these practices are not uncommon in food and beverage companies. As a result, poor food and [...]
How to Simplify CAPA Management with a Cloud-Based QMS
Corrective and preventive action (CAPA) violations are the most frequently cited non-compliance in FDA 483 inspection observations. In 2020, nearly 200 violations were cited among medi [...]
