Part 11 (help)
Recently (July) the FDA introduced Part 11 regulations for computer generated data and equipment. I work in a GLP environment and recently purchased two histology stainers (June) that are not passcode protected. This has created a documentation nightmare. I would like to hear from anyone who is dealing with this type of issue or who has found a sane way of dealing with the paperwork. I should add that there are eight to ten individuals using these instruments at any given time on any day. Looking forward to comments and advice.
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