T
Hi there,
I am after some advice. We have a plastic moulding operation and part of this requires maintaining run charts of certain dimensions on the parts made.
The plastic parts are components that we then assemble into Class 1 and 2 medical devices and sell.
We are investigating a PC based system data capture system which interfaces with various dial test indicators. This has the ability to perform the statistical functions we require and print the chart out. It is a software package that accepts and processes the data. This would interface with hardware that we supply.
We intend on keeping the paper copy as the quality record. We are still quite some time away from having a part 11 compliant system to keep the electronic copies.
What questions should I ask of the software vendor?
Ideally they could supply all the software validation documents to show the software does what we will use it for.
What does the FDA look for in OTS software?
What have other people found in similar situations?
Unfortunately this is not my field, though I am learning fast
Thanks in advance for any information you might have.
Tim Sharp
I am after some advice. We have a plastic moulding operation and part of this requires maintaining run charts of certain dimensions on the parts made.
The plastic parts are components that we then assemble into Class 1 and 2 medical devices and sell.
We are investigating a PC based system data capture system which interfaces with various dial test indicators. This has the ability to perform the statistical functions we require and print the chart out. It is a software package that accepts and processes the data. This would interface with hardware that we supply.
We intend on keeping the paper copy as the quality record. We are still quite some time away from having a part 11 compliant system to keep the electronic copies.
What questions should I ask of the software vendor?
Ideally they could supply all the software validation documents to show the software does what we will use it for.
What does the FDA look for in OTS software?
What have other people found in similar situations?
Unfortunately this is not my field, though I am learning fast
Thanks in advance for any information you might have.
Tim Sharp