Guidance Required on Approval Lead Times

Where I work, a certain department takes literally months to review and approve qualification documents.Practically this means that after a protocol execution, there could be approvals from 3 depts say for January 2011 and then the last dept might sign it October 2011.:mad:

Apart from the shear awkwardness of trying to track documents, is there any ‘rules’ being broken, should executed protocols be approved in a certain time frame. Is there any guidance on this from regulatory bodies.


The only straight forward guidance is : Review, Correct, Sign and approve–It might take longer time.We all understand this as we went thru such process.

The only solution to this is a paperless documentation or paperless protocol formats–all on screen-Kneatvalidation is only solution.


Its a common problem within the life sciences, and one that seems to be an ever growing problem.

If you are not using an electronic system for your reviews that is the first thing I would at, plus incorporating

a turnaround time on review of documents into your validation plan…say 10, 15, 30 days etc.

Its actually important that documents are reviewed and approved within a short time period so that

all deviations etc are fresh in people’s minds.

Hope that helps

While I would like to think that an electronic (or other) tool could solve this problem, it’s clearly a process issue. Reviewers / approvers can ignore electronic prompts as well as they can ignore anything else. Having a tool in place won’t force people to do their job.

This is first and foremost a management issue. If management considers review & approval 2nd (or 3rd or…) priority then the people are naturally going to follow suit. I would almost be willing to bet that if you asked the people why they sat on the docs, they would say they’re too busy. If, however, management told them it was their top priority, it would get done!

First, take the time to find out why the delays occur. Maybe there are valid reasons (reviewer 1 is waiting on something from reviewer 2 who is waiting on something from reviewer 1). Second, determine if everyone on the review / approve list NEEDS to be there. If not, take them off!

Finally, discuss it with management. As Graham points out, it IS important to review and close out in a timely fashion. If you can associate cost to the delay then that will REALLY get attention (but that’s difficult to do). Offer alternatives - maybe a 1-time review meeting where all the reviewers / approvers get together and step through the doc(s) and at the end of the meeting everyone approves. Nothing like wanting to get out of a meeting to get things done! :slight_smile:

Do consider moving to the on-line based methods / tools. That can help facilitate matters. But first you have to address the process problem.

Thanks all for your inputs. No easy solution as I suspected…