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 .

  21 CFR Part 11 Checklists. We've come a long way....or have we? The year is 1997. Bill Clinton is in his second term, Windows 95 is revolutionary, a laptop only weighs 6-8 pounds and  21 CFR Part 11 , the US Food and Drug Administration's (FDA) regulation on electronic records and electronic signatures went into effect (enforcement to begin in 2001).  Two decades ago, most software used in the life-sciences industry was not compliant and many to most quality processes were managed via paper record. Read more .