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

CGI

The FDA’s draft Computer Software Assurance for Manufacturing and Quality System Software (CSA) designates patient safety and product quality as the basis for risk assessment and provides mechanisms for reducing the effort of computer system validation (CSV). GAMP recently formed the Global Computer Software Assurance Special.

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List of data breaches and cyber attacks in August 2020 – 36.6 million records breached

IT Governance

The post List of data breaches and cyber attacks in August 2020 – 36.6 Data breaches. Looking at you, uni COVID-19 track-and-test app makers Marriott faces London lawsuit over vast data breach Russian arrested for trying to recruit an insider and hack a Nevada company. million records breached appeared first on IT Governance UK Blog.

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List of data breaches and cyber attacks in November 2020 – 586 million records breached

IT Governance

The post List of data breaches and cyber attacks in November 2020 – 586 million records breached appeared first on IT Governance UK Blog. Don’t pay ransom on the promise your data will be deleted, because it won’t be Almost 11 million patients impacted by Blackbaud incident – and still counting Ticketmaster fined £1.25

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Balikbayan Foxes group spoofs Philippine gov to spread RATs

Security Affairs

The group focuses on Shipping/Logistics, Manufacturing, Business Services, Pharmaceutical, and Energy entities, among others. The group has been active at least since August 2018, it conducted multiple campaigns per month through October 2020. Victims of the group are located in North America, Europe, and Southeast Asia. .

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

Security Affairs

Group-IB , a Singapore-based cybersecurity company that specializes in preventing cyberattacks , has detected successful attacks in Western Europe carried out in late January 2020 traced to Russian-speaking threat actors. At least two companies operating in pharmaceutical and manufacturing sectors have been affected.

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

Security Affairs

Victims operate in the Banking/Finance, Construction, Defense Industrial Base, Government, Healthcare, High Technology, Higher Education, Legal, Manufacturing, Media, Non-profit, Oil & Gas, Petrochemical, Pharmaceutical, Real Estate, Telecommunications, Transportation, Travel, and Utility. .

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Learn. Transform. Advance.

erwin

When I look back, I should not be surprised that 2020 has been incredibly busy for us here at erwin. To survive and eventually thrive in the face of radical disruption requires transformation that’s just as radical: Developing new business models, like breweries and distillers manufacturing hand sanitizer.