apprenticek80
Registered
Hello everyone!
I'm new to the Cove and QA in general. I've been tasked with learning quality regulations and helping to build a new QMS (moving from a very outdated paper-based system to a hybrid of paper & electronic) for 21 CFR 820 (potentially ISO 13485, too) at my very small, post-market medical device company, and I've found this forum very helpful for gathering the basics as well as some more minute details as I'm getting deeper into Quality Systems. The other resource that has probably proved the most helpful to me as a complete newbie has been CDRH Learn and the modules there.
How much can I rely on CDRH Learn? Obviously it's not binding advice from the FDA's point of view but surely using the modules in accordance with the regulation itself for guidance has got to be a pretty darn good start for our new QMS, right?
Also, a more specific question to be sure, but something I'd like a second opinion on: in their "Quality Systems Overview" module as well as the rest of the post-market activity ones, CDRH constantly points out the seven main subsystems (CAPA, Management Controls, Design Controls, Production/Process Controls, Document/Records Controls, Material Controls, & Equipment/Facility Controls) of a QMS and refers to the four bolded subsystems as being the focus of FDA audits. However, they never actually touch on Material Controls & Equipment/Facility Controls other than briefly in the Overview. From what I can gather, these two subsystems are actually just composed of various aspects of Production/Process Controls split up (such as acceptance activities, distribution controls, storage controls, etc.). I'm aware the regulations are not prescriptive and every company does things differently, but I'm wondering if anyone else has experience with putting procedures that are generally deemed PPC ones into Material Controls and Equipment/Facility Controls and splitting it up like that. It just makes more sense to organize the subsystems like that to me, but will it present any issues when we get audited if they're separate—so long as everything is easily accessible?
Please let me know if I'm splitting hairs over something that won't matter much in the long run; it's just a mental roadblock at the moment as I'm having trouble developing an overarching structural organization for the entire QMS and moving forward with this big question hanging in the air. The way CDRH lays out seven subsystems then never explains two of them just really threw me for a loop early on. I guess this is more of a general structure/organization question than anything! Really just looking for some best practices or personal examples. Thank you!
I'm new to the Cove and QA in general. I've been tasked with learning quality regulations and helping to build a new QMS (moving from a very outdated paper-based system to a hybrid of paper & electronic) for 21 CFR 820 (potentially ISO 13485, too) at my very small, post-market medical device company, and I've found this forum very helpful for gathering the basics as well as some more minute details as I'm getting deeper into Quality Systems. The other resource that has probably proved the most helpful to me as a complete newbie has been CDRH Learn and the modules there.
How much can I rely on CDRH Learn? Obviously it's not binding advice from the FDA's point of view but surely using the modules in accordance with the regulation itself for guidance has got to be a pretty darn good start for our new QMS, right?
Also, a more specific question to be sure, but something I'd like a second opinion on: in their "Quality Systems Overview" module as well as the rest of the post-market activity ones, CDRH constantly points out the seven main subsystems (CAPA, Management Controls, Design Controls, Production/Process Controls, Document/Records Controls, Material Controls, & Equipment/Facility Controls) of a QMS and refers to the four bolded subsystems as being the focus of FDA audits. However, they never actually touch on Material Controls & Equipment/Facility Controls other than briefly in the Overview. From what I can gather, these two subsystems are actually just composed of various aspects of Production/Process Controls split up (such as acceptance activities, distribution controls, storage controls, etc.). I'm aware the regulations are not prescriptive and every company does things differently, but I'm wondering if anyone else has experience with putting procedures that are generally deemed PPC ones into Material Controls and Equipment/Facility Controls and splitting it up like that. It just makes more sense to organize the subsystems like that to me, but will it present any issues when we get audited if they're separate—so long as everything is easily accessible?
Please let me know if I'm splitting hairs over something that won't matter much in the long run; it's just a mental roadblock at the moment as I'm having trouble developing an overarching structural organization for the entire QMS and moving forward with this big question hanging in the air. The way CDRH lays out seven subsystems then never explains two of them just really threw me for a loop early on. I guess this is more of a general structure/organization question than anything! Really just looking for some best practices or personal examples. Thank you!
