AssurX Blog
Straight talk for regulated industries.
Cloud Computing Impact in the Energy and Utilities Sector
Technology-averse energy & utilities companies are about to embrace the power of cloud computing technology, say many leading experts. Cloud Computing Technology = Enhanced Perform [...]
Prioritize QMS Process Automation or Risk Failure
A common pitfall in QMS process automation occurs with a poorly planned process automation strategy. Too often, the temptation is to automate all quality processes at once and streaml [...]
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 [...]
