Hello all,
I've run into a recent issue in joining a new company and having a different background/interpretation of what a controlled document is, specifically with forms.
Let's take a CAPA form for example. Our form is revision controlled and is locked down from any form of editing. This leaves no option but to complete the CAPA in ink.
With my background, forms like this and many others were revision controlled, but had flexibility so that the author could type in what was intended. Does this free you to completely adulterate the form? To a degree, but my take on it is with common sense, training, and final approval of the form being correct at completion, you've met the requirements.
I understand not every one will be a carbon copy, but I feel you lose the ability to complete your objective properly to what even the regulations say if your hands are so tied by being stuck with limited fields, using ink, etc.
I also feel with ink you can corner yourself into unintended damaging verbiage that cannot be corrected without possibly losing hours of work.
Options I've been presented with are attaching typed copies, which seems a step toward my point and somewhat ironic because the attachment is my vision of the form itself.
I've pushed for templates with as much Design Control documents as I could because it is a sort of new concept here and I have a lot of experience in knowing that inking out a Design Control project is by no means efficient. Please let me know your recommendations, and thanks!
I've run into a recent issue in joining a new company and having a different background/interpretation of what a controlled document is, specifically with forms.
Let's take a CAPA form for example. Our form is revision controlled and is locked down from any form of editing. This leaves no option but to complete the CAPA in ink.
With my background, forms like this and many others were revision controlled, but had flexibility so that the author could type in what was intended. Does this free you to completely adulterate the form? To a degree, but my take on it is with common sense, training, and final approval of the form being correct at completion, you've met the requirements.
I understand not every one will be a carbon copy, but I feel you lose the ability to complete your objective properly to what even the regulations say if your hands are so tied by being stuck with limited fields, using ink, etc.
I also feel with ink you can corner yourself into unintended damaging verbiage that cannot be corrected without possibly losing hours of work.
Options I've been presented with are attaching typed copies, which seems a step toward my point and somewhat ironic because the attachment is my vision of the form itself.
I've pushed for templates with as much Design Control documents as I could because it is a sort of new concept here and I have a lot of experience in knowing that inking out a Design Control project is by no means efficient. Please let me know your recommendations, and thanks!