Compliance Group

  “ SaMD ” even reaches as far back as the 60s with Lockheed’s consideration of getting the first computerized information-handling system in the hospital sphere. And do we know who the first company was to be approved by the FDA as a SaMD? I’m sure there was a hybrid that led up to that, and my guess is it’s archived somewhere, but my research didn’t come up with a specific name, but rather several  SaMD  firsts. Read more .

  If you need a warm body for a  Validation  project, call the other guy, but if you need proficient, trained, critical-thinking resources, contact us.    Compliance Group carefully vets our resources. New employees are placed with veteran employees to shadow and learn from them. We routinely train our resources on Computer Software Assurance (CSA), Data Integrity, MS Word skills, trends in  Validation,  and regulatory enforcement activities.   Read More .

  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 .