We are a software company. Now we are developing a system for a pharmaceutical factory, the system is custom software which consists of LIMS, MRP, MES, ERP; each sub-system can not be performed isolatedly. In such case, how to do validation? Validate the systems separately or validate them as one system?
I would divide the validation into separate modules, and then have an integration test plan that tests all of the various interactions.
Sounds like a big project!
I agree with Graham. Divide and conquer. Try to structure your Software Design Specification into seperate modules for each sub-system (LIMS, MRP, MES, ERP). Try to keep the coding and programming standards consistent between modules. Identify all modules, maintain change control and traceability. Modules should be as distinct and as logically seperate as possible.
Why such a leviathan system? I can’t ever remember anyone putting these systems together in one requirement.
I would say it will be problematic to validate, since a round 70% of the data this system will process and or store, is outside the part 11 requirements. Which obviously infers approximately 30% will have to be part 11 compliant. What will you validate to FLC requirements, and what, from the validation point of view, will you ignore?
Laboratory Information Management System (LIMS)
Manufacturing Resource Planning (MRP)
Manufacturing Execution System (MES)
Enterprise Resource Planning (ERP)
I cannot really advise you further without seeing how the programs relate and what operating system they are sitting on. If you want to send me these details, at the email address below, I will take a look and see what advice we offer (free at this stage).
NOW AVAILABLE FREE DOWNLOAD; “SOP for VALIDATION”