Labeling Attachments

GOOD VALIDATION PRACTICE (cGVP)
1

How do you label attachments to protocols? Evidence generated through the execution , ie screen shots. Heated debates over this…

[LIST=1]

  • something like this Attachment Number, protocol Number, step number, page x of y and sign and date.
  • or just the attachment number
  • something in between

    Attachment Referencing

    [LIST=1]

  • What about an attachment Log (listing of all attachments)?
  • Reference to the attachment on the execution form?
  • both, one or none
    • 2

    Hi Meyert,

    Usually

    • Index at begining of protocol detailing all the attachments (this should suffice as a log)
    • Attachment number
    • Page number X of Y
    • Initial and date of person who took the screen shot
    • Would also like to see date and time on the screen by the clock if possible (to ensure the test was done on the correct date and time)
    • If it is a multiple execution on a number of different machine’s the unique identifier for that machine (may have a specific number)
    • Color screen shot if possible
    • PNG format, clearer than GIF and JPG.

    Ideally I would like to see all of the above.

    Also a clear indication on the protocol of where I should be expecting screen shots.

    Hope this helps.

    Good question comes up alot.

    Regards

    3

    Graham,

    So you left out protocol number and test step number…not needed? It is attached to the protocol so I guess it is redundant.

    Is the initial and date the person who did the screen shot or the one who labeled it? Because typically there is space in the protocol for the person to initial and date that they executed the step. Therefore, you have the same person signing multiple times for the same step.

    I had forgotten about grabbing the time and date, I typically request screen shots to include the entire desktop, including the clock. I think some applications, like snagit will allow you to overlay much of this on the screen shot.

    I get this question a lot too. It takes sooooo long to label the attachments…whine whine whine. I even showed them that labeling attachments is nothing compared to the amount of time they waste re-executing tests between FAT-SAT-IQ-OQ. We are talking weeks to hours.

    4

    [quote=meyert]Graham,

    So you left out protocol number and test step number…not needed? It is attached to the protocol so I guess it is redundant.

    [/quote]

    Yes those too