Compliance Group

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