Compliance Group

  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 .

  CSA is literally catching fire, but there remains a lot of bad information out there. Something I hear (or some variant of) every week is: "Is CSA cheating?" If CSA is a simplified, streamlined approach (test more and document less), how can it possibly deliver better results than a traditional Computer System Validation (CSV)? That just doesn't add up and other regulators (or customers who audit my organization) will think I'm cheating, won't they? Read More .