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Clear, actionable intelligence for regulated industries.
Expert perspectives that simplify complexity and support stronger quality and compliance outcomes.
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 tem [...]
Successful QMS Implementation Requires Clearly Defined Processes
Industry-leading quality management systems (QMS) are built with clearly defined processes and workflows developed by th [...]
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 accu [...]
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 sys [...]
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) [...]
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 i [...]
