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…

ISO 27001:2022: Adjusting to New and Merged Annex SL and Annex A Controls

ISO 27001:2022: Adjusting to New and Merged Annex SL and Annex A Controls

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….