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Showing posts with the label iQMS

Your Quality Management is Failing and Here’s Why

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.

Best approach to achieve an FDA/MDIC approved Quality Management System

  This is very true with a Quality Management System, but not so if your QMS is still on paper.    While there need to be several controls put in place plus various sets of eyes to review, handing paper from one set of hands to another creates inefficiencies and plenty of room for error.    What happens when you lose those papers? Remember when "your dog ate your homework"?    You  don't  want that excuse when it's time for your regulatory audit! The items below are accurate for any industry, from medical devices, pharmaceuticals, biotech to manufacturing and marketing salt-related products. The FDA will want to see everything to safeguard the consumer and see that their guidelines, MDIC, and GMP ISO 9001 regulations are being met. Read more .