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…

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…

An Overview of Strategic Threat Intelligence

An Overview of Strategic Threat Intelligence

Strategic 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. This white paper will cover: Strengthening Your Information Security Program Through Strategic Cyber Threat Intelligence (CTI) Good Sources of Strategic CTI