Validation

[I Love Meditech]

I would like to know if the vendor that helps with setting up a blood bank system can validate their own software?

[bldbnkr]

I have been through two different implementations, SoftBank and Meditech (yes we downgraded).  In both cases I did all of the validations myself.  For Soft I wrote my own scripts, for Meditech I used my scripts for truth tables but I used Meditech scripts for everything else.

[David Saikin]

I believe the FED recommends you do your own validation.  I concur.  It really gives you an indepth knowledge of your system

DON"T use the scripts provided by the vendor.  FDA recommends you make your own so that you validate only the portions of the system you will utilize.

I recently managed an upgrade (in progress when I arrived).  They used the scripts provided and validated the entire system.  Took hundreds of man hours and 60% of it was

wasted time. 

The FDA provides a guidance on validating BBISs.

 

[Kai]

We used a third party vendor called Korchek Technologies because FDA recommends independence of review in section 4.9 of "General Principles of Software Validation; Final Guidance for Industry and FDA Staff". 

I've attached the document below

FDA Validation Guidlines.pdf

[bldbnkr]

I should correct my statement above and I used my own scripts for the Electronic XM validations also.  

[AMcCord]

We came up on SafeTrace Tx in May. Haemonetics offered validation with a 'partner' company, but we chose to have our system validated by BC Solutions. Using a totally independent company seemed like a better idea.