AssurX has been in the business of configuring and implementing Enterprise Quality Management Solutions for two decades. Over that time, it has been a consistent finding that audit management [...]
Blog Home TAG: Audits
In Archives, Medical Device Industry, FDA Regulated Industries, Pharmaceutical Industry, Regulatory Compliance ManagementPosted
For FY 2016, FDA is requesting $4.9 billion to support our essential functions and priority needs, which is $425 million above the FY 2015 enacted level. Of the total funding, $2.7 billion in [...]
The FDA says IRBs (Investigational Review Boards) are not required to collect a statement of investigator assurance from studies they preside over. This is troubling. My first question would be [...]
Turnkey Quality + Compliance Management
IN ONE VERSATILE SYSTEMManage all quality and compliance activities, control risk and streamline workflow with a single easy platform.
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Quality Management Software
AssurX Quality + ComplianceA single versatile software system can improve quality, compliance and streamline workflow.