I’ve been assessing computer systems and manufacturing equipment for the updated Annex 11 and there’s one element not shared with Part 11 that I’m a little unclear about:
A written detailed description of the system should be produced (including diagrams as appropriate) and kept up to date. It should describe the principles, objectives, security measures and scope of the system and the main features of the way in which the computer is used and how it interacts with other systems and procedures.
While many of these details would be covered in validation documents such as the FDS, and the update requirement would be covered by Change Control, we’ve been debating what additional or new documentation woudl be required if any.
We have some ideas to address this such as new document types, or incorporating a description into an existing systems register, however I’d appreciate some other viewpoints.
Has anyone been planning or writing system descriptions for this requirement already, and what kind of format have they taken? e.g. A new comprehensive standalone document, or a summary that refers to other Validation or IT documentation?
Also, what would you consider the scope to be? For example, how would PC controlled equipment be handled as opposed to actual computer systems?
Thanks in advance for any opinions or ideas.