D
DrMarioQAMD
Hello All,
I am looking to perhaps receive some advice regarding 21 CFR 820 compliance and developing. The company I recently started working for is registered with the FDA and our quality system while it is sufficient in meeting regulatory standards is antiquated. It was developed in the early 80's and as the company has grown, additions have been made to comply with areas we're deficient. 30+ years later, we are still compliant but now are in possession of a QMS that's all over the place and bulky. It DOES serve its purpose, but I'm looking to streamline it to set us up for the future, which may include ISO certification and future 510k submissions.
At this point I realize that gap analysis from a 3rd party auditor will tell us where we're deficient, not help guide us in hitting the "reset" button. Any advice on how we can go about starting this huge undertaking? Would a template QMS help out by picking from our system and reclassifying to this? Maybe a service we can look into to help us along with this? Any help and advise will be greatly appreciated!
I am looking to perhaps receive some advice regarding 21 CFR 820 compliance and developing. The company I recently started working for is registered with the FDA and our quality system while it is sufficient in meeting regulatory standards is antiquated. It was developed in the early 80's and as the company has grown, additions have been made to comply with areas we're deficient. 30+ years later, we are still compliant but now are in possession of a QMS that's all over the place and bulky. It DOES serve its purpose, but I'm looking to streamline it to set us up for the future, which may include ISO certification and future 510k submissions.
At this point I realize that gap analysis from a 3rd party auditor will tell us where we're deficient, not help guide us in hitting the "reset" button. Any advice on how we can go about starting this huge undertaking? Would a template QMS help out by picking from our system and reclassifying to this? Maybe a service we can look into to help us along with this? Any help and advise will be greatly appreciated!