MVM Option
Hi, anyone using the MVM option? Does it really speed out the method validation process? I made some research and 90% of the companies that bought the option are not using it.
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To support your research, the company I work for purchased the option years ago and we have never used it.
However, as the "new" Empower admin I have started making plans with our local sales rep to setup formal training on MVM Q4 2019 / Q1 2020 so that we may actually begin to use the option.
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We have it but the general consensus is the training is quite rushed and if you aren't using it almost straight after your training, a lot of the knowledge gets lost. Also, very few people have the time in day to day lab work to create the templates required in the template projects to start into the validations.1
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Yes, the recommendation is to buy the bundle, Training + Consultation so Waters will create the protocols..criterias..reports...as a foundation. Thanks for your feedback!2
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I had looked into it years ago on a trial basis. I felt that it failed to offer sufficient flexibility for my various needs and, for how infrequent we execute validation, it just wasn't worth it (I think we've had only one formal validation in the last 24 months).0
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EmpAdm: that is exactly what I am working on getting setup with our local Waters team.
I am also in the process of adding Fusion Method Validation to the mix. This should enable us to automate the robustness DOE amongst other things.
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out of interest , where do you find this MVM option ie ,, is it an enabled tick option (PDA, dissolution) or see option when creating a sample set ?
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It is an option that can be installed with (or after) Empower. It has its own license requirements etc. and is not free, so it is not just a check box like PDA. It is a very good thing, if it is used straight away after training. Steep learning curve but the payoff is significant, especially if you have lengthy run times in the methods you're working with.0
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And also you need to paid for MVM user licenses, grated by the administrator integrity since they can't be control by Empower like the named user licenses. Thanks for all your comments!0
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We don't use it ("too complex, not flexible") but I know that at least one top10 pharma organization uses it with for of their validations.0
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thanks all
Any validation required of software when installing MVM and adding license ?
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Yes, usually a company SOP for software qualifications is followed. Waters offers system qualification services for MVM and has quite a bit of MVM literature and certificates available.0
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We use it to great effect. I have extensive experience in the lab doing method validations but became an Empower administrator at a previous company and worked with their validation group and Waters to learn MVM. Note that it works best on Empower 3 FR2 SR2 or later versions of Empower. I was hired into my current position of Empower administrator in charge of MVM in June 2016 and have it used to great effect at this point. We see about 80% decrease in validation turn around time along with 80% decrease in non-test lab events (both were only about 60% after the first 6 months of use, hit 80% as of a year). The key is to have someone that's MVM validation manager to be in charge of the whole thing. We have it in use at multiple sites with a core group of SMEs at each site. Protocol templates help a lot when you can get them. We've use it for over 800 validations so far.0
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We also use it extensively0
