Part 11 (help)

Hi Histonetters:

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.

Tish Floyd
<< Previous Message | Next Message >>