Computer System Assurance

  Data Integrity App What are need of computer system assurance? In a nutshell, assurance needs are the activities you need to address to ensure that a computer system works as intended. According to the FDA's Case for Quality initiative, determining these activities is a three-step process.   First, you must identify the intended use of the system, which is explained in the user requirements. Second, you must employ a risk-based approach to pinpoint the high-risk areas of the system, focusing primarily on areas that directly impact patient safety.   The final step is to determine when a failure in these identified areas will have a high-risk impact on the system's quality and safety. These areas will require the most rigorous validation. Risk-based assurance activities Once you have determined the assurance needs of the system, you will know the activities you must perform to address these needs. Key activities include: ·          Meet and validate user require

  Data Integrity App Are critical thinkers born or made? Critical thinkers are not born. We can all learn these skills and reap the benefits. Critical thinking helps you become a more persuasive communicator, a more effective problem solver and increases your emotional intelligence. Here’s how you can hone your critical thinking skills: ·          Practice active listening ·          Be curious and ask clarifying questions ·          Be humble ·          See the big picture ·          Practice self-discipline ·          Be objective (it’s the antidote for bias!) ·          Use your emotions carefully (don’t let them cloud your judgment) ·          Be self-aware (analyze your assumptions and biases)   How does critical thinking apply to CSA? Now that we know what critical thinking is and why it’s important, let’s examine how it applies to CSA and validation in general. When we perform validation, we must comply with regulatory requirements, our company’s qual

  Data Integrity App What is critical thinking? Critical thinking is a complex subject that’s difficult to define. Generally speaking, it is the rational, skeptical and unbiased analysis of factual evidence. The ability to reason is a critical thinking skill. Reasoning occurs when we use our knowledge of one thing, process or statement to determine if another thing, process or statement is true. Logical thinking is about connecting one thing with another. Critical thinking is about making sure those connections are valid and not influenced by assumptions or bias. You must become a logical thinker before you can become a critical thinker. But how?   Critical Thinking As the manufacturer—the company and people producing the product—you know the business and you know the processes. You’ve got the best insight into how risk is introduced, where it matters, and what’s going on from a process standpoint. Critical thinking is considering where the system could introduce a risk v

Data Integrity App Computer Software Assurance Benefits A reduction in cycle times such as test creation, review, and approval A risk-based approach means systems can be broken into features, so only those of high-risk will require scripted testing Reduced test script implementation time Reduced number of generated documents Testing focused on guaranteeing software quality Better use of supplier qualification Reduced time-to-value in product development It will potentially lower the cost of quality by requiring less time in testing and documentation. It will drive the team to achieve higher, quality, and productivity. Helps to maximize the use of validation and project resource expertise. A reduction in cycle times cycle times (test creation, review and approval) A system can be broken into features, and only the High-Risk features will require scripted testing. Lower number of detected defects for example script errors & configuration