How Climate Change is Impacting Management System Standards

How Climate Change is Impacting Management System Standards

In February of this year, the International Organization for Standardization (ISO) and the International Accreditation Federation (IAF) introduced 31 amendments to existing and new Management System Standards (MSS) that revolved around a prominent social issue that is not typically associated with MSS: Climate Change. Summary of Changes The amendments were announced in a joint communication…

Security Focus: Continuous Improvement in Legacy-Laden Environments

Security Focus: Continuous Improvement in Legacy-Laden Environments

Technology environments rarely exist in a pristine, perfectly updated state. More often, they resemble bustling cities, layered with historical architecture (legacy systems) and sleek skyscrapers (modern tech). While the allure of modern technology and services is enticing, neglecting existing infrastructure can create its own set of challenges. Because organizations tend to put more resources into…

Integration of Quality and Information Security Management Systems

Integration of Quality and Information Security Management Systems

In the dynamic and highly regulated realm of life sciences, where innovation meets precision, the implementation of robust, efficient management systems is indispensable. Two critical pillars in this regard are the Information Security Management System (ISMS) and the Quality Management System (QMS), governed by ISO 27001 and 9001. When implemented properly, these standards function hand…

What to Know About Implementing Artificial Intelligence Compliance Controls

What to Know About Implementing Artificial Intelligence Compliance Controls

In the last year, artificial intelligence has gone from vaporware to viable business-ready reality. From inboxes to manufacturing integration, machine learning is changing the way we at Dayspring think and work.  In fact, over 80% of this blog was written by and then re-vetted for accuracy by Bard, the Google chat-based AI tool.  As we…

ESG Programs for 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 focus…

2023 Data Privacy Laws and Cybersecurity Updates

2023 Data Privacy Laws and Cybersecurity Updates

What’s new in 2023? The Dayspring Technology experienced consultant has reviewed and compiled a list of newly released and updated compliance and management standards for the first half of the year.  Data Privacy and Cybersecurity Updates “There are a variety of privacy and related standards that have been proposed, released, or updated in the past…

2023 ISO Regulatory Compliance and Quality Management Standards Updates

2023 ISO Regulatory Compliance and Quality Management Standards Updates

We have reviewed and compiled a list of newly released and updated compliance and management standards for the first half of the year. A number of new ISO standards, sub-standards, and guidance documents have been published in the past six months. Below are the most important 2023 updates to the ISO Regulatory Compliance and Quality…

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

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…

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…

FDA Computer System Validation (CSV) vs Computer Software Assurance (CSA) – A New Era

FDA Computer System Validation (CSV) vs Computer Software Assurance (CSA) – A New Era

For more than 25 years, regulated life sciences companies have been performing FDA Computer System Validation (CSV) to ensure that systems used in the manufacture of regulated drug products and medical devices meet their intended use and satisfy data integrity requirements. This white paper will cover: What is the Difference Between FDA Computer Software Assurance…