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…

What is Root Cause Analysis in Quality Investigations?

What is Root Cause Analysis in Quality Investigations?

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…

What Are Quality Investigations for Life Sciences Compliance Systems?

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…

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

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…