A
ariannas
OK - let me start off by saying that:
1) this is a somewhat philosophical question, and;
2) I bet it has been asked before in the context of the FDA part 820 forum but I may not be asking the search engine in the right way.
I'm mapping out the number of processes needed for a brand new FDA-compliant quality system. Not only is this for a new company, its the first time I've led this sort of effort. Our plans are to produce only a single class III medical device to start with.
After spending (way too long) working through the regulations and guidance documents, and mapping out an initial path, I'm thinking that we will need to establish about 20 processes to get things going.
I thought I had done a pretty good job keeping the number of processes down. But Some of my colleagues think I have gone SOP-crazy.
So... knowing that the real answer to "how many processes are needed" is a) as many as it takes, and; b) as few as possible, would anyone on this forum be willing to share approximately how many medium-to-high level processes they have in the FDA-oriented quality systems they are involved with? I'd dearly love to get a reality check.
1) this is a somewhat philosophical question, and;
2) I bet it has been asked before in the context of the FDA part 820 forum but I may not be asking the search engine in the right way.
I'm mapping out the number of processes needed for a brand new FDA-compliant quality system. Not only is this for a new company, its the first time I've led this sort of effort. Our plans are to produce only a single class III medical device to start with.
After spending (way too long) working through the regulations and guidance documents, and mapping out an initial path, I'm thinking that we will need to establish about 20 processes to get things going.
I thought I had done a pretty good job keeping the number of processes down. But Some of my colleagues think I have gone SOP-crazy.
So... knowing that the real answer to "how many processes are needed" is a) as many as it takes, and; b) as few as possible, would anyone on this forum be willing to share approximately how many medium-to-high level processes they have in the FDA-oriented quality systems they are involved with? I'd dearly love to get a reality check.