Has anyone here validated the Venus 4.5 software for use in a GMP regulated environment? If so would you be willing to share your experience?
I am currently assessing the validation project a system comprised of STARlet/Venus/LVK and always love hearing from people who have already done it.
Thanks,
Our company has conducted numerous GXP Validations in FDA-regulated environments for our solutions. These validations typically focus on workflow specific Venus Methods and GeNovu Web applications, rather than the entire Venus system. For instance, large molecule labs may use our solutions to create Sample Dilution plates or perform Assay Steps. Each of these solutions has its own User and Functional Requirement Specifications, Protocol Report, and Test Scripts that are developed and executed.
An example of this looks like:
As described in section 2.1, the Venus software has been customized using the built in Venus Tools functionality to simplify the programming of the required Small Molecule QC Prep dilution scheme and analytical run parameters (plate setups, pipet tip type, etc.). Since the Venus application (including the Tools customization function) is commercial off-the-shelf software (COTS), validation of the software by the vendor is accepted and therefore customized parameter input windows do not require additional testing. However, the calculations derived by GeNovu (displayed in a customized window) to determine the dilution scheme for the Small Molecule QC Prep module will be tested for accuracy in this validation. In addition, the customized system will be tested via OQ to ensure that it functions as required.
Thank you for your input. Great info.
we are doing it right now and happy to discuss more or get any help which can make the process a little easy