I Love Meditech Posted September 9, 2019 Share Posted September 9, 2019 I would like to know if the vendor that helps with setting up a blood bank system can validate their own software? Link to comment Share on other sites More sharing options...
bldbnkr Posted September 10, 2019 Share Posted September 10, 2019 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. Link to comment Share on other sites More sharing options...
David Saikin Posted September 10, 2019 Share Posted September 10, 2019 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. bldbnkr 1 Link to comment Share on other sites More sharing options...
Kai Posted September 10, 2019 Share Posted September 10, 2019 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 1 Link to comment Share on other sites More sharing options...
bldbnkr Posted September 10, 2019 Share Posted September 10, 2019 I should correct my statement above and I used my own scripts for the Electronic XM validations also. Link to comment Share on other sites More sharing options...
AMcCord Posted September 11, 2019 Share Posted September 11, 2019 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. David Saikin 1 Link to comment Share on other sites More sharing options...
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