Hi there Elsmar Colleagues - I hope I selected the correct forum for my question.
Short version - I am the Supplier/Vendor Quality Manager for a clinical start-up working within cancer therapeutics. Previous to this position I held a number of Quality related roles over a 20 year span at a large Swiss owned commercial biologics company, 4 of those years within Supplier Quality there, also.
Most of my experience in SQ is working with direct material manufactures (filters, chemicals, SUT, etc.), but I’ve been asked recently to work on a qualification process for medical couriers, as we utilize patient donor material collected from several sites across many locations.
I'm sure many Quality Systems attributes still apply with couriers as do with material manufacturers, but I’m note sure what other things to think about.
Googling on the web for ideas, I’ve made note of the following things recommended to consider:
Thank you in advance,
Steve
Short version - I am the Supplier/Vendor Quality Manager for a clinical start-up working within cancer therapeutics. Previous to this position I held a number of Quality related roles over a 20 year span at a large Swiss owned commercial biologics company, 4 of those years within Supplier Quality there, also.
Most of my experience in SQ is working with direct material manufactures (filters, chemicals, SUT, etc.), but I’ve been asked recently to work on a qualification process for medical couriers, as we utilize patient donor material collected from several sites across many locations.
I'm sure many Quality Systems attributes still apply with couriers as do with material manufacturers, but I’m note sure what other things to think about.
Googling on the web for ideas, I’ve made note of the following things recommended to consider:
- Business License
- Transportation Permits
- Healthcare-related permits (such as permits for handling medical waste or transporting biological specimens)
- Health Insurance Portability and Accountability Act (HIPAA) Compliance Certification
- Driver’s License
- Courier and Delivery Services Certification
Thank you in advance,
Steve