Compliance Group

While it’s common for most people to use QA and QC interchangeably, there are differences between quality control and quality assurance. The distinction is often unclear and can be challenging to identify. Nevertheless, they have divergent origins even though they are related; quality control and quality assurance are elements of Quality Management. However, while QA works to prevent defects, QC aims to identify the weaknesses. In a nutshell, QA is preventative, and QC is reactive. Let’s see why. Read More .

Non-conformance management  is the key performance indicator and a revelation for systematic issues within the organization. The  Quality Management Software  holds a set of features that are essential for the employees of the life science industry to identify, document information, and investigate the cause of occurrence of the defect and the closure. The Quality Management tool with close-loop configurable workflow helps the companies better organize their Non-Conformance process and documentation. Furthermore, the quality tool provides traceability and visibility of information documented with just a click across the organization. Read More .

Earlier this year, I lived by a legit rocket scientist for nearly 30 years. This guy was amazing, beyond the obvious reasons! He was very conversant, generous, a helping hand, and even an ecclesiastical leader for our church, carving out an extra 20 hours per week to help his congregation. He had some stories from his rocket scientist days. Most of these stories he was not able to share since most were classified as Top Secret. He worked indirectly for Thiokol, an infamous name for rocket propulsions, namely, the Challenger Space Shuttle explosion. Read More.

  Let’s face it; nothing new can be said about  root cause analysis  (RCA). Standard RCA techniques have been around for decades, and before them being documented and referred to as RCA techniques, they were being employed. It is human to ask why. While it may not be human to ask why five times, it is natural to get to the bottom of problems. Unfortunately, in the regulated world of medical device and  pharmaceutical manufacturing , there is a temptation to require intense documentation to prove that not only was the real root cause found but that it was accomplished by following strict processes. The emphasis on establishing the work was done often takes away from  real RCA  and actual problem-solving. Read More.

 This blog will read about seven core elements of Quality Management Software that organizations can adopt. These elements would benefit the organizations immensely by enhancing their alignment to compliant and regulated quality processes. 1. Role-Based Access Controls 2. Structured Storage of Data 3. Clear Process Definitions 4. Documentation – Management and Control 5. Design Controls 6. Analytics/Reporting Insights 7. Open Channels for Feedback For More information about 7 Key Elements of a Quality Management Software: Read More

Companies in the life sciences, food, and cosmetics industries are all too aware of how fickle the market is, how dynamic their studies and those under investigation are, as well as their timelines for releasing a specific medical device or medication.  Adding to that, how your quality processes are going, or not going, and you have a recipe for   FDA 483 observations  or worse,   FDA Warning letters 2021 . How do companies get to this point? What are the differences? How does a company avoid them? Read More .

Errors are usually a part of any process, action, or activity. There is always a percentage of error that happens. The practice must be to refine it and bring the errors down as low as humanly possible.    To adhere with industry regulations and to remain compliant with various policies, quality processes of organizations have multiple checks and internal policies in place to address the non-compliances and errors that occur during the lifecycle of manufacturing a product. The focus of these processes is to address the errors, analyze them, fix them and ensure that they do not occur again.    Often during this process, the regulatory burden makes it difficult for quality process individuals to provide their complete focus to solving the errors in a way that they are traceable backward, permanently fixed, and provide insights about any matters that need to be addressed immediately.   One of the most talked-about and feared issues in a quality process is...