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Regulatory Information Management Systems: The What & the Why

Gimmal

Regulatory Information Management Systems/Software, or RIMS, are platforms that have emerged to assist pharmaceutical companies and medical device manufacturers in submitting products for regulatory review.

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Delivering responsible AI in the healthcare and life sciences industry

IBM Big Data Hub

With today’s new generative AI products, trust, security and regulatory issues remain top concerns for government healthcare officials and C-suite leaders representing biopharmaceutical companies, health systems, medical device manufacturers and other organizations.

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Using FDA’s Computer Software Assurance guidance to improve innovation and quality in life sciences

CGI

Food and Drug Administration (FDA) and the life sciences industry have collaborated to develop guidelines for improving quality best practices in the validation of computer systems and to harmonize with international standards. For several years now, the U.S. GAMP recently formed the Global Computer Software Assurance Special.

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National Safety Council data leak: Credentials of NASA, Tesla, DoJ, Verizon, and 2K others leaked by workplace safety organization

Security Affairs

In total, the backup stored around 9500 unique accounts and their credentials, with nearly 2000 different corporate email domains belonging to companies spreading across various industries. Having a development environment accessible to the public shows poor development practices.

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China-linked APT10 leverages ZeroLogon exploits in recent attacks

Security Affairs

The group has been observed while attempting to exploit the Windows Zerologon vulnerability in attacks aimed at Japanese organizations from multiple industry sectors in 17 regions around the globe. The latest campaign has been active since mid-October in 2019 and appears to be still ongoing.

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China-linked APT41 group exploits Citrix, Cisco, Zoho flaws

Security Affairs

The group hit entities in several industries, including the gaming, healthcare, high-tech, higher education, telecommunications, and travel services industries. The APT41 has been active since at least 2012, it was involved in both state-sponsored espionage campaigns and financially-motivated attacks since 2014.

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New financially motivated attacks in Western Europe traced to Russian-speaking threat actors

Security Affairs

At least two companies operating in pharmaceutical and manufacturing sectors have been affected. According to industry researchers, TA505 is known to have carried out attacks on banks, medical institutions retailers and other businesses in the past. Group-IB has immediately contacted the victims upon discovery.