An auditor acquaintance of mine at the MHRA clued me in to GAMP 5 being published. I have promptly ordered the guidelines and plan to heavily review and comment on them.
GAMP 5
Computer Systems Validation seems to be an extremely hot topic these days, as it is a huge "unknown and mystical" money sink a lot of companies simply outsource. As much as I am a fan of outsourcing, I think CSV should be heavily associated with at least some arm of your internal IT department. It's a giant Venn diagram.
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