"Purchasing Controls" for Stand-alone Software

K

keldez

Involved In Discussions
#1
#1
Hello all,
First off thanks to everyone that has made Elsmar possible. It has been a life saver for me. It's a shame to see it go.

On to my question.. I'm currently developing the our Purchasing Controls (from 820.50) procedure supporting our single product, which is a Class 2 stand-alone software. As I comb through the requirements and even some articles related to the matter, I'm finding the scope of what applies to be almost non-applicable. If someone could give me a sanity check I would appreciate it.
- Purchases from suppliers: There are none, unless one would make the argument to start tracking purchases of computer hardware and software (very mainstream) used to develop the product.
- Evaluation of the suppliers: Requires application of the "Purchases from suppliers"
- Purchasing Data: I haven't determined any significant equipment/components that support the production of the product of product itself. The one exception is the User Manual, which is controlled, distributed electronically to the third party label for our product.
- Receiving Inspection (outside the scope of Purchasing but aligns with the theme): As the theme suggests, there are no "unit" based or tangible product supporting the DMR that appear to require inspection.

I've never been in this situation of such little to no application, so it doesn't feel right. Is there anyone else out there in a similar situation, or can enlighten me on maybe where I've missed something. Thank you!
 
GAGEpack - Gage & Calibration Management
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Y

yodon

Leader
Super Moderator
#2
#2
I'll toss out a few thoughts...

If your only purchase is computer equipment (you're not purchasing services for software integration, you're not purchasing cloud storage services, etc.) then you still want to have assurance that the equipment you buy is reliable (as can be expected) and legitimate. For example, if you buy from Fred's Oil, Lube, and PC services because they are extremely cheap, you may not get quality equipment (and may be loaded with bootleg OS, etc.). You DO have expectations for the supplier (probably a business whose primary purpose is computer equipment / electronics, offers some kind of quality of product, etc.). Only needs to establish your requirements and show that the selected supplier(s) meet them.

In terms of receiving inspection, just a review of the spec sheet to ensure you got what you ordered would be reasonable. If you ordered a system with a 500Gb hard drive and received one with only 125Gb, you wouldn't accept it probably.

Doesn't need to be a big deal, but does need to be a deal.
 
K

keldez

Involved In Discussions
#3
#3
Thank you for your thoughts.
I have gone back and forth on taking a similar approach. I feel somewhat like I'm trying to fill empty space just to fill it. I understand the importance of having the appropriate computer equipment to product.
Maybe I could take the approach of some sort of "inventory matrix" based on how vital it is or associated risk of the equipment to the product to ensure the equipment and software is accounted for and legitimate.
I'm a little hesitant to go down the rabbit hole of adding, for example, Dell and Microsoft as suppliers.
 
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