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...
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...
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...
Hi this is what you need ? https://www.pharmaguideline.com/2012/01/cleaning-validation-protocol.html
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...
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...
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