Pmx Mes

COMPUTER SYSTEM VALIDATION (CSV) 21 CFR PART 11
1

Hi,
Im presently working for a company that is in the process of implementing an e-manufacturing system.
Has anyone any experience working on a PMX MES, creation of the complete validation life cycle of documents, etc.

Any information would be greatly appreciated.

Thanks.

2

What’s PMX? Are you referencing Rockwell Software’s MES? If you want MES information, post that. I am in the process of validating Werum’s MES solution.

3

Dear KieranMcG,

Yes we have also mes installation with rockwell. This is a quite complexe validation exercise. Sir, you must first start with vendor assessment audit, to ensure that the vendor satisfies all of your business reuirments in terms of how system was developed.

With such big validation the validation must be broken down into modules or validation units in your validation plan. Sometime similar as to a LIMS validation project.

What does this mes rollout over in terms of manufacturing?