Editor’s Note: In this two-part series, you’ll learn common pitfalls to avoid and the most effective ways to select an Enterprise Quality Management system. Selecting an enterprise [...]
Blog Home MONTH: December 2016
In FDA Regulated Industries, Pharmaceutical Industry, Quality Management, Regulatory Compliance ManagementPosted
Document management problems could soon impact the momentum in the number and speed of drug approvals for the pharmaceutical industry. FDA’s Office of Generic Drugs (OGD) record Fiscal Year [...]
In eMDR, Medical Device Industry, Quality Management, Regulatory Compliance Management, Risk ManagementPosted
Risk management and adverse event reporting protocols for medical device manufacturers have been addressed by a new FDA guidance. Producing and controlling electronic records will be critical to [...]
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