CFR Part 11 compliance - IMAQ applications

[caleyjag]

I am writing an automated inspection application for a pharmaceutical company. The application is for the manufacturing line and therefore needs to be compliant with FDA requirements.

 

As far as I can tell the DSC module is designed to handle e-signatures and the like, but I'm concerned flags will be raised as to the compliance of LabVIEW and the Vision Development Module itself.

 

I'm using basic edge detection tools to measure critical dimensions on glass syringes. Nothing too fancy.

 

Has anyone successfully used the NI Vision toolbox in approved, Part 11-compliant applications?

 

I'm hoping to hear of some success stories so I can feel confident I am building this around an appropriate library.

 

[Antoine Chalons]

Hi,

 

I did work on a similar vision application (controling glass syringes) using LabVIEW + VDM and I also used DSC, but only or the security part (user management).

I wasn't asked anything more than a user manual to go along with my the sotware, I think the customer dealt with whatever documentation was required.

The customer is an american company but my app is - as far as I know - only used in european factories. I also know that "they" (this american company) developed their own brew of the system and it does run in factories in the USA and it's LabVIEW + VDM, no DSC though.

 

Hope this helps

[shoneill]

CFR part 11 is a doozy.

 

Tehcnically, it should be impossible to adjust recorded data after acquisition without the system keeping a record of the changes made and who made it.  There can be no access to the data without signing on.  A perfect audit trail must be made fromt he original acquisition to report generation with all changes logged and recorded and everything not exposed.

 

If the DSC module handles this, then it should be OK, but knowing people working in the Pharmaceutical industry (I'm actually an analytical scientist myself), I wouldn't want to be carrying the responsibility for certifying the software ase CFR Part 11 compliant.

 

Shane.

[caleyjag]

Yeah unfortunately I am going to be the one carrying the can here, and it's my first crack at a proper Part 11 application.

 

I'm basically concerned that the IMAQ library may have one or two many bugs for it to be sufficiently stable. That's not necessarily a Part 11 issue as such, but in order to meet the needs of the application I need to be sure my choice of LabVIEW is a logical and robust one.

 

That's why I'm hoping some people can vouch for the efficacy and reliability of the Vision Development functions, especially if they have tales from the pharmaceutical perspective.

 

Thanks!