I work for small company (~23 people) that within the last couple of years transitioned from doing R&D in a very industry to contract manufacturing.
I'm basically a chemist who got put in charge of quality. As I used to work in pharma yeas ago (although in R&D) I have some exposure to GMP, but am not experienced in quality.
We don't make medical devices or software but we are looking to do contract fermentations for enzymes/biologics (and maybe eventually our own products) for companies that make diagnostic kits and/or vaccines - components fro such things... Ours would be technical grade which our customers would then polish and either use themselves or sell to others to incorporate into such products. We know other companies who do such things are 13485 even though they don't make medical devices.
As such, even though it would not be required, management believes it would help us in that market to be ISO-13485, and we are starting on that path (we just recently got ISO-9001 certified and are looking to have/keep both). The goal is to get IS013485 certified by next April...
Initially we based our quality system on a paper system from about 15 years from my last company (Pharma Drug delivery so GMP and had ben FDA audited) but it gets to be a lot for a small company with a basically paper/excel etc systems...
To help us get organized and meet 13485 (or FDA type) expectations we are looking at ERP systems and are considering one called DEACOM.
I was wondering if anybody here has experience with it in a 13485 environment, and if so can say how well it supports 13485 quality systems. What functions does it handle well, as well as what it does not handle and is best done outside the system.
The sales people just say it handles Quality and mentions CAPAs and some kinds if change control but without lot of details... and one should always take what sales people say with a large grain of salt!
Hearing from anybody who has lived with the Deacom ERP in a 13485 environment would be very welcome!
Thanks,
-Karen
I'm basically a chemist who got put in charge of quality. As I used to work in pharma yeas ago (although in R&D) I have some exposure to GMP, but am not experienced in quality.
We don't make medical devices or software but we are looking to do contract fermentations for enzymes/biologics (and maybe eventually our own products) for companies that make diagnostic kits and/or vaccines - components fro such things... Ours would be technical grade which our customers would then polish and either use themselves or sell to others to incorporate into such products. We know other companies who do such things are 13485 even though they don't make medical devices.
As such, even though it would not be required, management believes it would help us in that market to be ISO-13485, and we are starting on that path (we just recently got ISO-9001 certified and are looking to have/keep both). The goal is to get IS013485 certified by next April...
Initially we based our quality system on a paper system from about 15 years from my last company (Pharma Drug delivery so GMP and had ben FDA audited) but it gets to be a lot for a small company with a basically paper/excel etc systems...
To help us get organized and meet 13485 (or FDA type) expectations we are looking at ERP systems and are considering one called DEACOM.
I was wondering if anybody here has experience with it in a 13485 environment, and if so can say how well it supports 13485 quality systems. What functions does it handle well, as well as what it does not handle and is best done outside the system.
The sales people just say it handles Quality and mentions CAPAs and some kinds if change control but without lot of details... and one should always take what sales people say with a large grain of salt!
Hearing from anybody who has lived with the Deacom ERP in a 13485 environment would be very welcome!
Thanks,
-Karen
