Do we have to create a device file for each individual device? Can similar devices such as vacuum buffer tanks be included in one document?
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RT, welcome everyone to share your valuable suggestions.
In the same workshop, for the same purpose, there are now more than 3 vacuum buffer tanks of identical specifications – can they be placed in the same folder?
In the same workshop, for the same purpose, there are now more than 3 vacuum buffer tanks of identical specifications – can they be placed in the same folder? I think it’s possible; my 32 adsorption towers come in two different specifications, so I created 2 files for them
I’m not sure if there are any specific requirements for GMP audits
A device file is the record of a device, starting from its design and procurement and ending with its disposal; in principle, there is one file for each device. If it can be ensured that all information related to each individual device is accurately and clearly reflected in the file folder, I believe that devices of similar types or with similar functions can be managed together, which facilitates comparison and reference!
Thank you for your valuable suggestions. :)
I thought it wasn’t possible; although it’s the same design, the person who creates it isn’t necessarily the same, and the materials and equipment used may also differ. Equipment records include the original documentation from the production process, and one set of records is required for each piece of equipment.
There should be one equipment file per device. Each of us has a personnel file of our own; when have you heard that the files of people from the same school or the same age group are combined together? With the same device, you can store several file folders in one place, but you cannot put the files of several devices in a single file folder.