FDA Software Validation

[korchek]

How does the FDA feel about vendors validating their own software? Isn't independent review a covenant of Quality Assurance? Mediware started by restricting who can validate their systems. Now Wyndgate has followed in their footsteps by offering validation through PeopleMed, another Global Med company. Don't these companies have a vested interest in how their software is tested?

The blood bank does not even know this is happening because these services are buried in contracts that are signed in the "ivory tower". Blood bankers need to be involved with selection process and contract negotiation.

[L106]

Interesting....I hadn't heard about this. Are you saying that after the hardware and software is installed, the computer company has to sign-into your system and perform the validation testing (and no one from the site is required to do any validation?) (Thanks for the info!)

[korchek]

I am not sure how they present it to the end user. I would not be comfortable with the vendor telling me everything is OK, don't worry about it. Would you?

[David Saikin]

You are supposed to validate your own system . . . YOU may select a vendor to validate it for you, but having a satellite company of your system (or vice versa) do it does not sound kosher. I wonder if the FDA is aware of this practice?

[Alternatives]

When time comes to validate our monitoring solution, some companies or organization have time, ressources and budget to do it by themselves. Some others prefer to give us the mandate to do it.

Protocol for IQ/OQ qualification has to be approved and signed by both parties before execution; if customer does not feel comfortable with some points we discuss and change could be done in the protocol. Once approved and signed, customer could execute it, or we could do it. Here's too, it depends of time and ressources. Then a report is written, and approved by both parties.

So, following this, both parties are included in the decision process to accept or refuse to approve each document. Customer and us are involved in the whole process. The difference is who is going to to do the job!

Benoît

[Alternatives]

BTW, i found this ISBT interesting doc about validation of automatic systems in blood bank.

Benoît

ISBT Guidelines for validation and maintaining validation state automated systems blood bank.pdf

[Judy hedglin]

The National VA office has released a new BB computer system earlier this month. Yesterday I was involved in a teleconference regarding what all acediting agencies would be looking for. A question was asked from Kansas regarding close faclities on the same server (Leavenworth and Topeka) as to if one facility could validate and use documentation for both. As it was pointed out, each facility has different BB procedures and validation at the facility will cover this. Any hardware or software is validated by the supplier before release, but we must validate the system to our own processes. Hope this helps.

[grace]

Judy: Is the new national VA BB system identified as coming from Cerner?

[smartesoft-biased]

As far as we can tell the FDA cares very much about the quality of the validation, period. We've never seen any bias with regard to who performs the validation, as long as they know what they are doing.

(We work with a lot of entities that implement BB validation. We do not do the validations, we just help automate them as requested under the guidance of those with domain expertise)

Gordon

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