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Validation of Manufacturing Execution Systems

In many industries Validation is defined as the documented evidence that a procedure, process and activity will consistently lead to the expected results. It often contains the qualification of Systems, Utilities, Facilities, Equipments and Processes. It is a requirement for GxP (where x = Manufacturing/Clinical/Laboratory/Distribution).

Validation is according to FDA's "Establishing Documented Evidence that provides a high degree of assurance that will consistently producing a process specifies a product meeting its pre-determined specifications and quality attributes." (FDA 1987). A properly designed system will ensure a high level of assurance that each step, process and change is well assessed before the implementation takes place.

Manufacturing Execution Systems (MES) bridging the information gap between ERP systems and process control systems. When these systems are used in a GxP regulated environment, these systems are subject to validation. ISPE GAMP®5 issued by the Good Practice Guide (GPG) is on this topic

We will start with a short summary of GAMP®5, ISA-88 and ISA-95. Aftwerwards the GPG is explained in a practical way.

Prior knowledge of validation according to GAMP® is required. If not present, we recommend to follow our training Computer Validation according to GAMP®5 & Data Integrity first.