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smartesoft-biased

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  • Birthday 01/01/1965

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  1. Hi all, My name is Gordon and I work for a firm (SmarteSoft, with an "e" in the middle) that specializes in automation of blood bank validation. We do the software validation automation under the guidance of those running the validation, using SmarteScript, and do not have the BB domain expertise ourselves. We have helped enable automation of validation for users of MAK, Mediware, Haemonetics, Cerner, and perhaps some others I am unaware of. (Many of the automations are done by partners using our software, so we do not always know what blood bank software validation they are implementing) We work with vendors, validation consulting firms, and blood bank staff, to either implement the automation for them or support them to do it themselves using our tools. Our tools do not require scripting/programming skills and are gaining wide acceptance in the healthcare field beyond blood bank. On a personal note, a big thankyou to the blood bank community. Members of my family have twice had need of blood transfusions, and they owe their lives to your work. g.
  2. 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.
  3. 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.
  4. All good points. There has been a great deal of success with automation of validation, pre-test data seeding, data migration, performance testing, and various other areas, using SmarteScript and Smarteload. Users include the American Red Cross, the UK National Health Service, and many more. SmarteScript does not require any scripting skills, and is quick and easy for building and maintain validation automation. There are versions of SmarteScript optimized for specific blood-bank software (eProgesa etc), making it easier yet. The testing harness capability you mention is already built in to SmarteScript. SmarteSoft, the vendor of SmarteScript, works proactively with validation specialists (e.g. RF Nozick) and blood bank professionals to help them develop automated validation capabilities. Gordon - Disclaimer: I work for SmarteSoft and am thus likely to be biased no matter how hard I try to be neutral.
  5. Between vendor self-validation and doing your own validation is the third option of independent third party validation. There exist independent firms whose whole focus is on this type of validation. They are not tied to the software vendors, and they have deep expertise in this type of validation. For example, RF Nozick do nothing but blood bank validation, and do not sell any software. They are independent and unbiased. Cheers, Gordon [Disclaimer: I work for SmarteSoft, who provide test automation software that is used for automating testing/validation of blood bank and other software. While I try not to let that influence what I say here, any views I express may be inadvertently biased due to this industry participation, and should be filtered accordingly]
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