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The biotechnology industry is making another attempt to ease Sarbanes-Oxley (SOX) reporting and auditing requirements for smaller companies to ensure that product innovation is not hindered.
To help device firms remain in compliance with Medicare and Medicaid regulations, AdvaMed is asking HHS' Office of Inspector General (OIG) for clearer guidance on physician investments in firms that make or distribute devices.
The biotechnology industry is making another attempt to ease Sarbanes-Oxley (SOX) reporting and auditing requirements for smaller companies to ensure that product innovation is not hindered.
Compliance with 21 CFR Part 11 demands that an FDA-regulated life-sciences company use a set of three key system-specific standard operating procedures (SOPs) to support validation efforts, says a new white paper from industry vendor MasterControl.
FDA-regulated life sciences companies too often make the mistake of approaching erecords management in a fragmented manner that leaves them vulnerable to inspection problems and puts their products at risk, experts at Open Text told PIR last week.
The Tanzania Food and Drugs Authority (TFDA) has issued an initial draft Compliance and Enforcement Policy for pharmaceuticals, medical devices, foods, cosmetics and herbal remedies, underscoring the East African nations commitment to
establishing a comprehensive regulatory process to protect public health.
Some IT managers, chief information officers and others at FDA-regulated life sciences companies say they wish for more clarity from the FDA when it comes to risk management and 21 CFR Part 11 requirements, but for many companies it is hard to know just how much regulatory compliance they want to call for.
A key strategic necessity for effective IT governance and compliance is the ability to integrate, automate and centralize the process controls implemented by the organization, says a new IBM white paper.
The vast majority of FDA-regulated life sciences companies still believe computer system validation and 21 CFR Part 11 compliance are important even as agency enforcement lags, according to EduNeering CEO Donald Deieso.
Government enforcement agencies are increasing their scrutiny of deceptive advertising practices in the marketing divisions of device and diagnostics firms, an FTC official said June 20.