Hi all,
I am writing a software validation protocol for a customer and intend to keep a copy of the document archived at my company HQ. In the opening preamble i plan to mention that a copy of the document will be held by us and a .pdf copy will be sent to the customer. Can anyone tell me if there is a legal requirement for the amount of time i should keep the template? Obviously a paper record will be filled out and left at the customer site…so do i need to keep the template at all? (Obviously i will be keeping it anyway, but i just wondered if i should mention that in the protocol).
Hope that makes sense.
Kind regards
J.
Are you in charge of this document?
I assume you are since your customer will have the PDF copy and you have the editable word version.
In terms of any changes I assume you are in charge of the change control and issuing the updated version of the document.
I am not sure what the legal requirements are but I assume you will need to keep this document for the life cycle of the system.
If this is the case this should be documented in the documentation section of your protocol where locations can be given.
Regards
Thanks for the speedy response (LinkedIn friend 
)
I will indeed own the document and have included provision for entering where everything will be kept. It will be a one off document, designed to show our product is suitable for use - under the current working conditions within the company. All signed documentation will be left on-site, so it will be their responsibility - though i will make a note of its location.
I am just wondering if i should let them know that the template will be kept by us. I would imagine we would normally keep thses things for 5 years or so, but have in the past seen figures of 25 years quoted. I wanted to know if there was a figure i should work to - after all, if the completed documentation AND the pdf is misplaced/destroyed by the customer then surely i cannot be held responsible??? We will, of course, copy the document to our server, so it will probably survive longer than me, but is it better to say its safe with us for 20 years, or just steer clear?
Its a fairly trivial point, but it got me thinking!!
Unless they have stated this to you, I would steer clear.
Keep a copy but just dont document that you are doing this, in this document.