I have seen the long discussions about screen shots and what version to save in . We are going to start using Camtasia to record the entire execution. We decided that the Part 11 risks are outweighed by the value of the recording. The execution is completed in 1/4 of the time, and the reviewer gets to see the entire execution. We are running the test and then burning to a DVD or CD. Also the level of paper documentation is reduced, no more writing actual results or debating whether “as expected” is valid.
What is Camtasia not aware of this application/software, how is it used??
It is from the same company that does snagit…Techsmith. Camtasia allows you to record the entire execution performed on a computer. The reviewer therefore watches the qualification. You can record as an avi, or the native camtasia file. It’s a free download to try. No camera is involved. also the executor can type comments or with a microphone commentate the execution.
Thanks for that, seems like a tool that could come in very handy for complicated executions or even as a training tool on how to operate software for different applications.
Here’s the link for anyone who would like to take it for a test run.
How did you get buy in from the powers that be, is this a valid way to represent an execution according to the FDA ???
I never really thought of asking. I brought this to our QA and told them this is how we are going to start executing our validations. I wrote a procedure around its setup and use. Since it was off the shelf software, I did a small risk analysis and determined that no testing was required.
The key to the use of the software is in the setup. How do I make sure that someone can’t change the results. I require the entire desktop to be recorded, including time at the bottom. No hiding the task bar. 2nd - the software has its own timestamp that shows recording time. I can then see if the recording was stopped or paused. If the recording is stopped or paused, a deviation is required.
The biggest issue with using this technology is the electronic record that is created. For this, I have the person executing document the file name, size, and time:date in the protocol. Paper audit trail if you will. This e-record is then recorded to WORM media (DVD or CD). Then as a reviewer, you can ascertain whether the recording was doctored. Any editing would change the size and probably the date stamp. A person would have to go to great lengths to falsify data.
I think it is really easy to defend and actually a step or 10 higher up the stairs of compliance.
Very interesting indeed, seems like an excellent way to record an execution going forward.
The execution is completed in a 1/4 of the time, is there a time reduction or paper reduction in any other part of the lifecycle.
For example would the reviewer of the execution have to review the video execution and the OQ protocol, surely this would increase the reviewer’s time?
Yes, the reviewer would have to watch the video while reviewing the script. This a great point and I must congratulate you on your astute observation. If in fact, everyone who is post-approving the test or report must watch the video then I have effectively doubled, or tripled (or worse) the review time. Not a satisfactory solution nor an improvement. However, if approvers did not have to watch the video, then certain efficiencies would be realized. We pondered this exact question, and over came this by adding a script conclusion box that includes the typical PASS/FAIL, comments, but also a statement that “My signature below indicates that I have viewed the associated video file for this test script and certify that the script was executed as documented.”
Approvers could review the video if they desired, but really are not required. If the approver needs clarification for an entry in the test script, they can use the recording to see what happened.
Pls clarifym, with this camtasia- validation is void of report generation because the execution is captured for review.The two aspects to be performed by the reviewer is to watch the execution video and verify with protocol and approve it,
Nope, you still summarize the results of the validation study. The evidence is on DVD or some other format. Reports generally have a discussion of the results, the resolution of deviations, and the status of the validation (pass/fail).
After using camtasia for a few validation protocols, I have found that it is not appropriate for all validation. It is wonderful for OQs, point and click style protocols. Not really appropriate for IQs or PQs.
And it is a great training tool. We are in the process of embedding the video of someone executing a task in one of our SOP.
I am hoping someone will jump in on this.
My department is discussing the use of video evidence when executing test scripts and some of the current thinking is that by doing this the entire validation process timeline will be significantly reduced. In a way I tend to agree with the statement, but in my opinion one of the more time consuming exercises is the actual writing of the test script.
To lay a little ground work - we are in the process of pulling together the Validation of a LIMS system for sample release and stability testing.
When pulling together the test scripts, how detailed would yo make the scrtips. What is being proposed is a Test Objective, Step #, and Action Steps. So you would have something like:
Test Objective: Create a Vendor and confirm entry in audit trail
Step # Action Step
1 Browse to the Vendor list page
2 Add a Vendor
3 Confirm Audit trail
Would this be sufficient?
Brain Storming Discussion Man…very brief.
Hi Meyert : Can you share the current status of use / fullness…
Sorry for disappointing you. I have audited a computerized system validation documented by creating movies like this. I found it inappropriate because as an auditor you cannot spend hours watching one silent movie.
It may be appropriate if you split it into small sequences imbedded into protected PDF documents to document one test case at a time. However you still need to document test instructions and acceptance criteria and clearly provide evidence that the test was successfull.