Quiz by: SLE
Murtuza Vasowalla: So, a lot of people ask me “What makes a great quality management system?” And I’ll tell you there’re five things really.
The first is you really have to have a good solid document management system. So, where you’re in the pharma space, in the biotech space, your format, you’re managing SOPs, you’re managing work instructions, specifications, and you want people to have a good solid control on those documents. So using control, essentially audit trade, etc. You wanna make sure that is running in a very good system.
The second thing you need is a very good electronic forms management system. So, you have companies that are managing deviations kappas. Whether they’re manufacturing for themselves, they’re manufacturing for others if they’re CMO. They need to be able to prove that they have good solid records on deviations kappas. When they get audits that are performed on them, they need to be able to capture those observations. So you need a very good forms and workflow management system.
The third thing that you need is a good sort of integration, because you’re running manufacturing systems.
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