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  1. Micheli Lermen
    Post

    ISO (80002)

    Ah, ok, thank you for this... my only doubt still about the 'scope' of 80002/2017, "Medical device software -- Part 2: Validation of software for...
    Post by: Micheli Lermen, Jul 16, 2018 in forum: Qualification & Validation (Also 21 CFR Part 11)
  2. Micheli Lermen
    Thread

    ISO (80002)

    Dears, Do you think ISO (80002) could be used instead of gamp 5, if we are talking about a company that works only with warehouse of drugs and...
    Thread by: Micheli Lermen, Jul 16, 2018, 2 replies, in forum: Qualification & Validation (Also 21 CFR Part 11)
  3. Micheli Lermen
    Post

    Network server validation - Record Retention

    I think it 'll be good if you do an FMEA and describe how do you control who has access to change and edit files inside this folder, use strong...
    Post by: Micheli Lermen, Jun 14, 2018 in forum: Qualification & Validation (Also 21 CFR Part 11)
  4. Micheli Lermen
    Post

    Cleaning Validation Master Plan

    Hi this is what you need ? https://www.pharmaguideline.com/2012/01/cleaning-validation-protocol.html
    Post by: Micheli Lermen, Jun 14, 2018 in forum: Qualification & Validation (Also 21 CFR Part 11)
  5. Micheli Lermen
    Thread

    Service Desk system - Software Validation

    Dears, I need to know your opinion about the need for a system validation for a healthcare warehouse company it service desk software. My point...
    Thread by: Micheli Lermen, Jun 13, 2018, 1 replies, in forum: Qualification & Validation (Also 21 CFR Part 11)
  6. Micheli Lermen
    Thread

    Hi

    Hi folks, I´m from Brasil and I spend my life working with IT Only, now I´m working with QA also, so I´d like to talk about GAMP 5, SW...
    Thread by: Micheli Lermen, Apr 24, 2018, 2 replies, in forum: New Member Introductions
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