Software Validation Documents

CHERYL EASTEP

• 6 de octubre de 2023 15:47

Westone is ready to start using Bartender for medical device labeling.  I have been using Bartender for 10+ years.

I am looking for canned version of Installation Qualifications, Operational Qualifications and Performance Qualifications.  Wonder if there is something available to ease my process.

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  Xabier Clemente

  Moderador

  ★ BarTender Hero ★

  • 17 de octubre de 2023 04:02

  Hello Cheryl,
  
  Thank you for reaching us via our Community Forums!
  
  It sounds like you are asking if BarTender validated for the following:

  • IQ - Installation Qualification.

  • OQ - Operational Qualification

  • PQ - Performance Qualification

  
  The short answer is that BarTender cannot be validated. Systems are validated, not components. An OQ testing protocol for validation generally starts with “Engage the power switch. Does the system turn on? Yes / No,” and then runs through every possible iteration of system action and its result. Other kinds of software, ones that are a system in and of themselves, can be validated. Integrated software cannot be. It gains its validation as part of the larger system. 
  
  If you have any additional questions or concerns about this issue, I will have to direct you to call our Sales Team or reach them by email at sales@seagullscientific.com.
  
  Also, if you are looking simply for technical specifications, they can be found at the link below:

  • BarTender Technical Specifications

  Let us know if there is anything else we can do you for.

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