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Part 11 No discussion of computer or control system qualification will be complete without at least an overview of Part 11 (21 CFR Part 1110). This part of the CFR…

Introduction This chapter will provide an overview of how computer controlled or automated units are to be qualified and then validated as part of and included with process systems. Note…

1Ostrove, S.: Qualification and Change Control. In: Validation of Pharmaceutical Processes, 3rd Ed; Editors: Agalloco, J., Carlton, F. New York: Informa Healthcare USA, Inc., 2008, Chapter 9, pp. 129–145. 2Title…

Figure 5.1 Equipment and utility qualification flow chart. Utilities that have no direct product contact are usually only commissioned, not qualified. This also depends on the contact the system has…

Factory Acceptance Test and Site Acceptance Test As mentioned above, the user specifications are usually general in nature. For example, they would say we need a V blender with temperature…

Determining the Level of Qualification Before determining what testing needs to be performed in the Factory Acceptance Test (FAT) or any other commissioning or qualification test, one needs to determine…