Q
Looking for Best ISO 13485/FDA QSR QS Development Software
Hi,
Boy am I frustrated! I have a lot of experience in the Q&R field, but am currently in a small company and need to develop an ISO 9001, ISO 13485 & FDA QSR compliant quality system. Since I'm not a big fan of typing and I have some serious resource constraits, I'm looking for available tools that I can purchase to use as a framework for defining the quality system of this business. The reason that I am frustrated is that I just purchased software from a company that said they had a quality system that would be simple and small and meet our needs perfectly. When I looked at it, the quality manual alone was 122 pages (and this was just ISO 9001 & QSR, I was going to add the delta for 13485).
Does anyone have a suggestion as to where I can purchase software that I can use that is small, simple and ensures that the regulations requirements are coverred. At this point, I'm considering writing the whole thing, but hope that I won't need to.
Any help would be appreciated. Thanks.
Hi,
Boy am I frustrated! I have a lot of experience in the Q&R field, but am currently in a small company and need to develop an ISO 9001, ISO 13485 & FDA QSR compliant quality system. Since I'm not a big fan of typing and I have some serious resource constraits, I'm looking for available tools that I can purchase to use as a framework for defining the quality system of this business. The reason that I am frustrated is that I just purchased software from a company that said they had a quality system that would be simple and small and meet our needs perfectly. When I looked at it, the quality manual alone was 122 pages (and this was just ISO 9001 & QSR, I was going to add the delta for 13485).
Does anyone have a suggestion as to where I can purchase software that I can use that is small, simple and ensures that the regulations requirements are coverred. At this point, I'm considering writing the whole thing, but hope that I won't need to.
Any help would be appreciated. Thanks.
