Aim: Computerized systems (CS) are essential in the development and manufacture of cell-based medicines and must comply with good manufacturing practice, thus pushing academic developers to implement methods that are typically found within pharmaceutical industry environments.
Materials & methods: Qualitative and quantitative risk analyses were performed by Ishikawa and Failure Mode and Effects Analysis, respectively.
Results: A process for qualification of a CS that keeps track of environmental conditions was designed and executed. The simplicity of the Ishikawa analysis permitted to identify critical parameters that were subsequently quantified by Failure Mode Effects Analysis, resulting in a list of test included in the qualification protocols.
Conclusion: The approach presented here contributes to simplify and streamline the qualification of CS in compliance with pharmaceutical quality standards.
Keywords: Failure Mode Effects Analysis; Ishikawa; academic institution; cell therapy; computerized system; good manufacturing practice; qualification; validation.