Hi,

I am looking to purchase a good OEM SW program that will allow us to control the manufacturing process; for example, to enter data about components/parts used during the manufacturing process, and to create a DHR for the finished product (medical device). If possible, the program should be flexible enough to allow us to enter data that applies to our specific situation, e.g. during assembly, we might use a part/component that was manufactured in different lots, so we will need to enter the different lot numbers in the DHR in order to identify and trace critical components.

Any recommendations for such a SW program??

Thanks,

Asherlee

Hi,

I am looking to purchase a good OEM SW program that will allow us to control the manufacturing process; for example, to enter data about components/parts used during the manufacturing process, and to create a DHR for the finished product (medical device). If possible, the program should be flexible enough to allow us to enter data that applies to our specific situation, e.g. during assembly, we might use a part/component that was manufactured in different lots, so we will need to enter the different lot numbers in the DHR in order to identify and trace critical components.

Any recommendations for such a SW program??

Thanks,

Asherlee

Asherlee,

Just for clarification and benefit of our international Participants:

SW = Software?
OEM = Original Equipment Manufacturer?
DHR = Device History Record?
Is that correct?

Stijloor.

Correct!!!!

We had a client use Made2Manage. I can't attest to its goodness, but I believe it either directly covered the items you listed or could be customized (scripts, etc.) to do so. Maybe this will get the ball rolling.