Compliance Management Solutions

esg life sciences quality management system standards

ESG Programs for Quality Management System Standards

In recent years, modern enterprises are increasingly evaluated by more than the traditional definitions of quality and value in the products or services they provide.    “Consumer, investor, regulatory and public eyes now focus on corporate environmental, social responsibility and governance (ESG) awareness as a key part of the brands they engage and support. This... Continue reading

2023 Cybersecurity And Regulatory Compliance Updates HIPAA, DOT, GDPR, FTC & SEC (1)

2023 Cybersecurity Updates: HIPAA, DOT, GDPR, FTC & SEC

What’s new in 2023? Dayspring Technology has reviewed and compiled a list of newly released and updated cybersecurity and regulatory compliance standards for the first half of the year.    “Businesses that operate in regulated industries should stay up-to-date on these changes to ensure that they are in compliance,” says Ryan Coleman, Dayspring Technology Principal... Continue reading

FDA Updates “Ensuring Cybersecurity of Medical Devices”: Simple solutions using your current Quality Management System

FDA Updates “Ensuring Cybersecurity of Medical Devices”: Simple solutions using your current Quality Management System

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... Continue reading

Quality Investigations For Life Sciences Compliance Systems _ Dayspring

What Are Quality Investigations for Life Sciences Compliance Systems?

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... Continue reading

Compliance Solutions For Life Sciences

Compliance Solutions for Life Sciences: Intended Use of Computer Software Assurance

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... Continue reading

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