Hello, to those who have gone through the new inspection checklist can you kindly tell me how many screen captures I should use? Did you use anything else?

Thank you.

**NEW** 07/11/2011

TRM.22000 LIS Transfusion Validation Phase II

The laboratory information system is validated for blood banking/transfusion medicine activities.

NOTE: The LIS must be validated at initial installation, and when a change is made to the system. All possible anticipated permutations of processes should be checked (e.g. electronic crossmatching and release of group specific products). Most laboratories utilize a series of screen captures to demonstrate the processes in the LIS. Records of system validation must be retained for at least two years beyond the service life of the system.

You need to demonstrate compliance - only you know how many screen shots you need. Do you need any? I used to capture the warning messages when/where they were supposed to occur. Make certain you define what you are trying to capture/validate and just document that. I have never seen an inspector pour through a thorough system validation (even the FDA). If you possess reams of papers with validation cover sheets, an intelligent individual will peruse a few and ask a few questions about the rest (what problems you encountered, how they were resolved, etc). To perform a complete verification of a system validation is a major undertaking. When I inspect, I ask to see any new validations since the previous inspection. I look for a rational approach. I think this is a what a good inspector does - you are supposed to be assessing your operations, including validations, and determining if your system is up to your standards. The inspector should only be concerned that you have done validations in a reasonable manner. There are many ways to skin that cat.

We used a screen capture software called Camtasia. It was awesome, saves a lot of paper. It captures your whole validation session in a file that you save on your computer. We have it on a drive that is backed up by our IT dept.

Thank you Dave and tbostock this is very helpful!!

Hey Dave, would you come and inspect our Blood Bank!!

I guest this would be different, right? I am glad they made it easy. From X's website:

XXX Validation Verification Package

XXXs Development, Inc. has over 20 years of experience devoted to designing and revamping its lifecycle, which includes program testing. When requested, we provide documentation of this validation to our customers as a means for them to measure our internal dedication to quality product design. This Validation Verification Package contains the following items for your examination:

• XXX Development LifeCycle (DLC) Validation Process

• Modules Validated in using test scripts

• Validation Completion by Spreadsheet

• Samples of Completed test script pages

• Certificate of ValidationFinal documentation of the test scripts, above, encompasses approximately 6000 printed pages. Forease of review, selected representative samples of pages have been provided.......

SD

. I have never seen an inspector pour through a thorough system validation (even the FDA). .

After we implemented a new system we had an FDA inspector review over 100 test scripts and sit through a whole day watching the screen captures (actually mini-movies) we made using HyperCam. Murphy's Law: If you don't have it they will ask for it. They want to how QA warnings are generated and what triggers the QA warnings. They want to know that reaction tables work. If you do electronic crossmatch you have to prove that it works as described and will not allow exm if the patient has only one typing, positive antibody screen, etc. They look at dates performed and reviewed/approved and signatures. We had one question us because the date of validation on a test script was after go live of the particular function (it was a file transfer for TD results from the testing lab to the donor system). They didn't read the description that said final validation after go live.

I too am an inspector and ask what changes have been made since the last inspection and review that validation. Not only computer, also what new processes have been put into place.

Validation is more than having a set of screen captures showing your processes. Validation should include verifying the system against a set of requirements - statements on how you want your system to work. You also need to perform a risk analysis of the system functionality and requirements and then validate the highest risk items. You want to challenge your software, not only to ensure compliance but to ensure that the system provides patient safety. Proof of performance - either screen captures, video captures, or reports - should be made to demonstrate that your defined requirements were meet. Documentation of validation, including requirements, test scripts, proof of performance, issues found, conclusions, and review, can be kept electronically as long as you can find what you need when you need it.

Kathy Patterson, MT(ASCP)SBB

Thank you, does anyone mind sharing an example of their written procedure on how to validate.

Hey Dave, would you come and inspect our Blood Bank!!

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I would be honored to, but . . . it is a bit far. You can always email me your SOPs and I would be happy to give you my opinion If I am ever in the neighborhood I will definitely look you up.

Thank you, does anyone mind sharing an example of their written procedure on how to validate.

Liz - here is my validation template: I use if for everything.