Has anyone used any validation software for thier computer validation? Software such as Cyrano, which runs a script on a PC to simulate normal and stress testing.

Was it really a time saver?

Did the cost of the software balance with the time savings?

Were you happy with the results?

And have you gone through any inspections (FDA or AABB) post validation?

No, haven't used it.

We just used Software Testing Solutions. It was a great time saver and I was very pleased with their testing and reports. I am due an AABB inspection any minute so I have not been inspected since we used this. I did a validation of their validation and then used it to help validate for an upgrade. I still had to work on the different test plans but they did the general plan and it was wonderful. With staffing cuts, I do not know how I would have accomplished this. All of the blood bank maintenance and testing is performed by either the blood bank supervisor or one of the blood bank staff. Neither the LIS coordinator nor IT does any of the blood bank LIS troubleshooting, maintenance or testing. Therefore, it was a great help to me (the blood bank supervisor). The thing that acutally swayed us into buying this software was an unexpected absence of several months of the primary person who knew the system (the blood bank supervisor)and did the maintanance just after a major upgrade to GUI. It was noted at that time that the staff who was left would not have been able to handle the blood bank workload plus the time involved in a major upgrade and the system was obtained.

A very significant number of blood banks, including many of the largest, have used SmarteScript for automation of validation, and/or SmarteLoad for load testing.

References from a number of such facilities are available should you wish to find out more. Just drop me a line and I will put you in touch with some of them.

You can also see some more info here: http://www.smartesoft.com/customers_bloodb.php

Gordon

- Disclaimer: I work for SmarteSoft an am thus biased no matter how hard I may try to be neutral.

I've had experience both ways...I'm a fan of doing the validation myself. You have to perform your own validation anyway after they are done, you have to show that you have performed site-specific test cases. And I always find glitches that the validation companies did not. But that's just the neurotic side of me.