Software Validation Documents
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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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:Let us know if there is anything else we can do you for.
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Dear all,
I've read the comment here that components are not validated, but systems are. What about Librarian. We need for example to keep all versions (treacability) of labels and integrations as they are part of the system. Does anything exists to include Librarian directly in the quality system ? So is there any specifique document to validate Librarian so that it can be refered to from the QMS system ? Do you have any experience with this ?
Thanks.
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