Should you have version control on document templates?

GOOD DOCUMENTATION PRACTICE (GDocP)
1

Hi All,

I would be interested to hear your opinions on the following…if you have a set of validation document templates do you need version control on them?

So far example if a change is made to a IQ document template should it go through a formal version control with approval like a SOP.

Thank you.

2

I wouldn’t. What good would it serve? If you make a change, you’re not going to go back and change all the IQ documents based on the previous template. Further, I prefer the flexibility to adapt templates as needed for the specific need at hand. Deviating from a version-controlled template would then have to be defined and defended. (I have a similar disdain for the proliferation of version controlled forms - some are necessary to always ensure required information is captured, but I digress).

There is the risk that someone copies the (now) old version and continues using it. Any reasonable document review should catch that so the risk should be eliminated.

Some companies, though, may require (by SOP) version control for all templates and frankly, doing so might be best for a company. If a company is better served by managing them this way, it doesn’t hurt (unless the extra overhead is particularly painful).

3

Thanks Yodon…I guess there is an argument to be made for each approach taken. From my experience to date the larger tier 1 companies like to mange all of their validation templates through version control. I was just wondering if this was a requirement or just a common stance taken by these companies.

4

I guess it depends how you use templates. If they’re just a guide for what should be included in a document, then maybe there is a case for not controlling them.
If however, in your procedures you state that a specific template must be used, then they better be controlled.

While you don’t have to update previous documents after you update a template, how would you know which version of the template was used.

I too have seen that it is typical for larger companies to meticulously control templates, which would sometimes be really burdensome because not even the smallest deviations were allowed; but one reason for that may be that very often auditors expect that the templates are controlled.

5

Thanks Mikez…I concur with that,

6

We version control them. I can’t imagine not doing that. How do you know if you are using the most up to date template if you don’t?