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On December 29, 2022, the Consolidated Appropriations Act, of 2023 was signed into law by the United States Congress. This massive, $1.7 trillion bill addresses a range of international and domestic issues and includes a new amendment to the FD&C Act in section 524B, Ensuring Cybersecurity of Medical Devices (section 3305). It impacts anyone seeking […]

Root Cause Analysis (RCA) within an organization’s quality Investigations process allows an investigator to determine the likely cause of a non-conformity. It is important that a company routinely evaluates the components of its quality systems, including RCA, and how it meets and exceeds life sciences compliance standards.  While there are many ways to go about […]

When was the last time you wrote a research or term paper? Were you evaluated on requirements like font size and theme? Spacing? And who could forget a word count? Often, extraneous requirements intended to guide continuous improvement and corrective action tasks, like investigations, cloud the value of effective analysis and investigational writing. Yes, space-conscious […]

Many companies looking for compliance solutions for life sciences systems are leaning heavily toward Computer Software Assurance (CSA). However, there are several things to keep in mind before implementing them into your systems.  When getting started with CSA, companies should first determine the intended use of the software. This term is discussed in the Code […]

For more than 25 years, regulated life sciences companies have been performing Computer System Validation (CSV) to ensure that systems used in the manufacture of regulated drug products...

Cyber Threat Intelligence (CTI) is the discipline of obtaining and filtering information regarding the occurrence and assessment of technical, operational, and physical threats in global cyberspace.

Cyber Threat Intelligence (CTI) is the discipline of obtaining and filtering information regarding the occurrence and assessment of cyber, operational, and physical threats in global cyberspace.

In October of this year, the ISO Information security, cybersecurity, and privacy protection subcommittee (ISO/IEC JTC 1/SC 27) released ISO 27001:2022 and supporting guidance documentation.

Quality Assurance Consultant

With the recent release of ISO27001:2022, the full extent of both new and merged cyber security compliance is finally clear! Most InfoSec bloggers have pointed out the Annex A reshuffle from 14 domains to 4 clauses (Organizational, People, Physical and Technological), and the resource tables in the appendices of ISO27002:2022 map old to new controls. […]

Earlier this year, the ISO/IEC JTC 1/SC 27 released ISO27002:2022. This guidance document gives us some insight into what the new ISO 27001 standard will look like, and some good changes are coming! It appears that the number of Annex controls will drop from 114 to 93 and 11 of the Annex controls are a […]

Life Sciences Consultant

Cybersecurity Changes are Coming Earlier this year, the ISO Information security, cybersecurity, and privacy protection subcommittee (ISO/IEC JTC 1/SC 27) released ISO27002:2022. This guidance document gives us some insight into what the new ISO 27001 standard will look like, and some good changes are coming. Many industry experts and consulting firms have shared their take […]

Cookie compliance is essential for all businesses collecting consumer data. Cookies are a tracking technology utilized by internet web browsers for user personalization. Cookies track site sessions to streamline the consumer’s experience and also acquire personal data. It’s important to consider data privacy laws when utilizing cookies for gathering or selling personal data. Laws to […]

Data privacy laws can have many nuances but it’s crucial that your business adheres to California Consumer Privacy Act (CCPA) compliance. In this article, we break down CCPA requirements and how they affect your business. California Consumer Privacy Act CCPA was approved by the state of California in 2018 and affects organizations that collect, retain, […]

The General Data Protection Regulation (GDPR) is legislation derived from international privacy and human rights laws and GDPR Compliance is essential for businesses located in the European Union (EU) and/or serving clients in the EU.  History of GDPR The GDPR was approved by the (EU) in 2016 and protects an individual’s personal data by establishing […]

How Do Organizations Support Data Protection Compliance? Over the past several years, data protection compliance laws have expanded. Here at the top privacy laws to be aware of. Top Privacy Laws CCPA/CPRA California Consumer Privacy Act/California Privacy Rights Act (CPRA) CPA  Colorado Privacy Act  UCPA  Utah Consumer Privacy Act  VCDPA  Virginia Consumer Data Privacy Act GDPR  […]

Security Privacy Consultant