AssurX Blog
Straight talk for regulated industries.
Successful QMS Implementation Requires Clearly Defined Processes
Industry-leading quality management systems (QMS) are built with clearly defined processes and workflows developed by the implementation team. While initially it may seem overwhelming, [...]
China Addresses Life Sciences Regulatory Compliance Concerns
China has often faced criticism for lax regulation of drug and medical device manufacturing. In addition, long-term accusations of bribery for inspection favoritism is still a real con [...]
FDA Warning Letters Emphasize Document Control System Compliance
First-quarter 2017 Food and Drug Administration (FDA) warning letters emphasize a lack of effective document control system compliance. Two recent warning letters are patent examples. [...]
FDA States Clear cGMP Expectations for Combination Products
The Food and Drug Administration (FDA) recently released a final guidance on Current Good Manufacturing Practice (cGMP) Requirements for Combination Products. This guidance provides cl [...]
Avoid QMS Automation Failures with the Right Implementation Team
Even after decades of eQMS availability, a staggering number of projects still suffer when the QMS implementation team isn’t right, ready and responsible. Regardless of your QMS softw [...]
Cybersecurity Management Expectations Clarified By FDA
The FDA has made it abundantly clear that it expects medical device manufacturers and other life sciences firms to have strong cybersecurity management programs. Since the FDA hasn’t a [...]
