I have been asked to provide a recommended strategy for validation of an MES system.
The scope of the project includes the plant control systems and their interface with the MES. There are 100 - 200 items in the list of equipment for the site. I do not know the validation status of those control systems, but part of the strategy I develop should address those systems.
I have GAMP4, GAMP5, and am familiar with their contents, I’m trying to develop a strategy specific to MES, its interface with plant floor equipment, and the individual control systems.
Thanks for any insight/recommendations. Also, if any of you know any good articles or sites, I’d appreciate the info.
This is a very broad question but I will do my best to offer some advice.
As you have said above the first thing you need to do is determine the validated status of the periphery equipment as part of this validation will involve integration to the MES system.
GAMP 4 and GAMP 5 are good guidelines but I think the first thing you need to do is develop an overall validation master plan that includes details of everything in scope.
Have you developed the process maps for the system and how they integrate with external equipment and if the process maps themselves are correct? Have you spoken to the SME’s in relation to this?
What type of MES system are you using?
Is there anyone else working on this with MES experience, sounds like a big project.
I actually have 2 assignments.
We are visiting 2 potential clients about MES projects.
One client has an installed and functional MES that they want to validate. All we know about it right now is that there are 100-200 items on the equipment list for the site.
The other client wants us to assist them throughout the design phase of their MES system. They haven’t selected a vendor.
I will be visiting both these clients soon to discuss the overall process. We will be discussing analysis of their current process, and the design phase of the new process. We will also talk about risk assessments, validation plan, URS. I’ve gone through this process with several control systems and a couple of ERP systems, but never MES.
I’m basically in the research phase and trying to gear myself up to ask the right questions and gather the correct information. The client asked us to present a strategy. With almost no information about the actual systems, I’m trying to present as much as I can regarding what would need to be done for MES systems in general.
I realize this is a broad question. I just trying to do my homework I thought I’d find some pointers here.
You know I havent got a validation.
The names Yukito_guy and my e-mail:
Yukito_guyyahoo.co.uk
And my friend too
Hes Shounen and ask Neko-chan for more details, thanks.