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  1. Airwolf
    Thread

    IQ, can it stand alone?

    Hi guys Regarding IQ of an inhouse-built machine, built from other machines and CE-marked etc. I want to do an IQ for the installation of the...
    Thread by: Airwolf, Jan 2, 2020, 1 replies, in forum: Qualification & Validation (Also 21 CFR Part 11)
  2. Airwolf
    Thread

    CE-marking for 24 VDC motor?

    Hi all I hope I post this in the correct forum. It probably pertains to the machinery directive and the LVD. We are building a tumbler, with a...
    Thread by: Airwolf, Nov 21, 2019, 0 replies, in forum: Manufacturing and Related Processes
  3. Airwolf
    Post

    Questions about 100 % measurement

    Yes, why would we lose data. I know I am looking for a solution to a problem that I do not have. However, management has decided to come up with...
    Post by: Airwolf, Nov 11, 2019 in forum: Sampling, Standards and Inspection
  4. Airwolf
    Thread

    Questions about 100 % measurement

    First, I am sorry if this comes across as confused - I am trying to figure this out. We have an automatic measurement assembled machine, in which...
    Thread by: Airwolf, Nov 7, 2019, 5 replies, in forum: Sampling, Standards and Inspection
  5. Airwolf
    Post

    IQ and OQ for assembled machine

    yodon, thanks for your reply. I did an IT change for the version update, and concluded (along with the machine build department) that no functions...
    Post by: Airwolf, Nov 6, 2019 in forum: Qualification & Validation (Also 21 CFR Part 11)
  6. Airwolf
    Thread

    IQ and OQ for assembled machine

    I am unsure if this is the correct subforum! But here goes: I have recently finished the IQ report for an assembled machine, created from other...
    Thread by: Airwolf, Oct 29, 2019, 2 replies, in forum: Qualification & Validation (Also 21 CFR Part 11)
  7. Airwolf
    Thread

    CFU count for DI water sample

    Hi guys I was unsure where to put this question -- so here goes. I have something called an "ELMA" cleaning line, which has several vats for...
    Thread by: Airwolf, Sep 20, 2019, 2 replies, in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
  8. Airwolf
    Thread

    New member, from Denmark!

    Hi guys! I am new here - I just found this forum, which seems like a perfect place for me. I recently started working as an QA engineer, though I...
    Thread by: Airwolf, Sep 20, 2019, 1 replies, in forum: New Member Introductions
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