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!
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!