Vendor Qualification Questionnaire

Please find the PDF attached

Vendor Questionaire.pdf (178.0 KB)

The PDF was useful. Could you please comment or answer to the following questions:

  1. Do you use it for ALL vendor qualifications? I mean, if you choose legal / IT / other vendors and (or) services, you still use these form or you develop other questionnaires?
  2. Do you determine in SOP or Work Instruction usage of the Questinnaire? Or this point should be mentioned in the other documents?

Thank you in advance,

Do you perhaps have a Vendor Qualification Questionaire for auditing of a company developing software for example a Process Automation system?

First, recognize that “Vendor Qualification Questionnaires” are not suitable for auditing a prospective company. They are only filters to ensure they meet your basic requirements.

Regardless, you’ll want to know if they have an established Software Development Life Cycle (SDLC) in place. If not, then they’re probably just a ‘garage shop.’ Even though it’s target is for medical device software, you could tailor a checklist based on IEC62304 to let them define their processes. Key aspects would include software configuration management and change control.

Another consideration is their experience on the target platform / environment. For example, a web site development shop may have software engineers that could do process control systems but if that’s not their ‘core’ business, the software may not be properly architected. Further, even if process controls is a core capability, if they have no experience on the target hardware, there could be some nuances in operations that could become problematic.

Since this is in the context of life sciences, you’d be wise to pick a supplier that has done software in the industry before. There are specific Qualification requirements that will need to be met. If they (or you) don’t understand those requirements, you could easily end up with audit findings or regulatory sanctions.

If you have no internal expertise about the whole software development process, you’ll want to partner with a company that can guide you through the process. You’ll want to emphasize collaboration rather than just throwing the requirements over the wall and waiting until they churn out a system.

While it’s probably outside the scope of your question, you’ll want to ensure that you always have control (physical ownership) of the software and related artifacts (design docs, etc.). This is often accomplished by having them send you baseline snapshots of the source code and documents. Make that explicitly clear when you start into contract negotiations.

I tried to open the attached PDF, but can not.May be it is closed?

1 Like