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Mark Warner (D-Va) recently published a whitepaper framing cybersecurity as a patient safety issue. Warner says the whitepaper is a starting point to open up a discussion about changes that can be implemented to improve cybersecurity in the sector, rather than a blueprint for change.
The whitepaper suggests several areas where policies could be changed to improve cybersecurity in the healthcare industry. Cybersecurity can no longer be viewed as a secondary concern; it must become incorporated into every organization’s – from equipment manufacturers to health care providers – core business models.”.
healthcare organizations, the Food and Drug Administration (FDA) asked MITRE to develop a Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook to help hospitals and healthcare delivery organizations (HDOs) develop a cybersecurity preparedness and response framework.
” – The paper sheds light on the critical issue of racial and ethnic diversity in clinical trials, exploring current industry initiatives, their effectiveness, and the future landscape shaped by the FDA’s evolving guidance. .
Regulatory Compliance: eQMS can help organizations meet industry-specific regulations, such as ISO 9001, FDA 21 CFR Part 11, and others. Download our whitepaper, How to Choose the Right eQMS , to learn how. Automated workflows and built-in compliance features ensure that businesses stay up-to-date with the latest requirements.
Its longer more formal name was The Drug Price Competition and Patent Term Restoration Act of 1984, and it created a pathway for generic drug applications to the FDA. the good old days of bipartisan policy making…another topic for another post]. This turbocharged a viable market for generic drugs in the U.S.,
Improved Compliance and Risk Management Regulatory compliance: eQMS solutions help organizations meet industry-specific regulations, such as FDA, ISO 9001 , and GMP, by providing built-in compliance features. Download our whitepaper, How to Choose an eQMS , for more.
For instance, a user could query a generative AI model trained on FDA life sciences regulations about AI use in drug development, and the model would provide a summary based on its training data. Choose an eQMS provider with proven life sciences industry expertise and a platform preconfigured to industry standards like FDA, ISO, and GxP.
Enhance compliance: Ensure compliance with FDA regulations, including CGMP and 21 CFR Part 11 , through automated compliance checks and audit trails. Strengthen regulatory compliance: Ensure compliance with FDA regulations, such as Quality System Regulation (QSR).
Regulatory Compliance Adherence to regulatory requirements, such as those outlined by the FDA’s 21 CFR Part 820, is mandatory for pharmaceutical manufacturers. Download our whitepaper , “A Step-b-Step Guide to Choosing an eQMS,” to learn more about CAPA and other key capabilities you need in your solution.
Regulatory Compliance Adherence to regulatory requirements, such as those outlined by the FDA’s 21 CFR Part 820, is mandatory for pharmaceutical manufacturers. Download our whitepaper , “A Step-b-Step Guide to Choosing an eQMS,” to learn more about CAPA and other key capabilities you need in your solution.
FDA 21 CFR part 11 requires a manufacturer to perform “Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.” This should include an initial test of the system permission settings for performance and functionality.
Medicines and Healthcare Products Regulatory Agency (MHRA) MHRA Launches AI Airlock to Address Challenges for Regulating Medical Devices that Use Artificial Intelligence, 09 May 2024 In April 2024, the MHRA set out its strategic approach to AI in response to a whitepaper that was published in 2023.
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