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Lutz: Perhaps you can expand on what you mean with 'article' number - is article number meant to convey part number or SKU? Perhaps you are referring to what some might call a line extension?   With some additional clarity, you might receive some valuable feedback. ------------------------------ ...

Dear Anon -  In addition to Anne's helpful reply, the specific CFR is 820.198 Complaint Files  Are two PMS plans needed - no; typically, the US CFR requirements are captured in the SOP(s) and output and a single PMS plan is suitable. ------------------------------ Scott Bishop McKinney TX ...

Dear Anon -  I think one of the critical distinctions to consider is whether they *only* work together and are only distributed 'together'.  Does the web app also function independent of the probe or with other products / probes?  Think ahead to the business plans as well -  Finally, considering ...

Dear Anon: You have identified two methods of achieving this - what does your quality system allow / define as the paths?  Which process makes the most sense relative to your associated processes to ensure the appropriate control on distribution of products with the appropriate labels? ------- ...

Ginger - great point. I have heard great things about Grand Avenue from your list and from my experience worth a review as well. ------------------------------ Scott Bishop Houston TX United States ------------------------------