Industry Perspectives
-
Computer Systems Validation Pitfalls, Part 3: Execution Inconsistencies
11/25/2024
The authors continue their article series on computer systems validation pitfalls by sharing a common mistake made by inexperienced senior QA personnel and more.
-
Defining When To Implement Technologies To Support Commercial Growth
11/20/2024
Technology decisions must be understood in the context of your business strategy and projected milestones. With a framework in place, you can define what tech solution you need and when you need it.
-
How Does Robotics Aid Occlusion Testing For Drug Delivery Devices?
11/5/2024
Robotic automation simulates, detects, and resolves occlusions under controlled conditions for drug delivery systems such as infusion pumps, catheters, IV lines, and insulin pumps.
-
Computer Systems Validation Pitfalls, Part 2: Misinterpretations & Inefficiencies
10/29/2024
In part 2 of the authors' series on computer systems validation pitfalls, they cover misinterpretations and unnecessary "nice to haves" that waste execution efficiencies.
-
Life Sciences Cybersecurity Incident Management: The End-to-End Approach
10/24/2024
Life sciences companies are focusing on smart manufacturing, digital supply chain, and leveraging AI/ML. A good cybersecurity incident response plan can make the difference between a cybersecurity incident versus crisis.
-
Computer Systems Validation Pitfalls, Part 1: Methodology Violations
10/9/2024
When computer systems validation work is not performed according to protocol instructions — by cutting corners on quality outputs with the focus on profit as the main driver — this can result in drug and device companies losing profits and efficiencies.
-
Sterility Assurance: The Fundamentals
10/8/2024
Sterility assurance is a critical aspect of the production of drugs and medical devices. This article covers the fundamentals, including the key components of an effective sterility assurance program.
-
Improving Medical Device Testing With Robotic Automation
9/25/2024
Recent high-profile failures and recalls of medical devices highlight concerns about patient safety. Robotic automation in verification testing can help with regard to precision, efficiency, and more.
-
Bacterial Endotoxin Testing, Part 4: Key Tests For Endotoxin Detection
8/7/2024
This article concludes the author's series on bacterial endotoxin testing. It discusses best practices for the labeled lysate sensitivity test, non-interfering dilution determination, and more.
-
Does My Medical Device Design Actually Work?
8/6/2024
In medical device development, the proof of feasibility stage often includes preliminary testing, but also detailed technical, usability, manufacturability, regulatory, and commercial assessments.