title: Qualification of computerized monitoring systems in a cell therapy facility compliant with the good manufacturing practices.
abstract: 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.
  
  
  
  Qualitative and quantitative risk analyses were performed by Ishikawa and Failure Mode and Effects Analysis, respectively.
  
  
  
  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.
  
  
  
  The approach presented here contributes to simplify and streamline the qualification of CS in compliance with pharmaceutical quality standards.
authors: Divisió de Teràpies Avançades/XCELIA, Banc de Sang i Teixits, Edifici Dr. Frederic Duran i Jordà, Passeig Taulat, 116, 08005 Barcelona, Spain.
authors: Anna
authors: A
authors: Del Mazo-Barbara
authors: Divisió de Teràpies Avançades/XCELIA, Banc de Sang i Teixits, Edifici Dr. Frederic Duran i Jordà, Passeig Taulat, 116, 08005 Barcelona, Spain.
authors: Clémentine
authors: C
authors: Mirabel
authors: Àrea Corporativa de Qualitat, Banc de Sang i Teixits, Edifici Dr. Frederic Duran i Jordà, Passeig Taulat, 116, 08005 Barcelona, Spain.
authors: Valentín
authors: V
authors: Nieto
authors: Divisió de Teràpies Avançades/XCELIA, Banc de Sang i Teixits, Edifici Dr. Frederic Duran i Jordà, Passeig Taulat, 116, 08005 Barcelona, Spain.
authors: Blanca
authors: B
authors: Reyes
authors: Divisió de Teràpies Avançades/XCELIA, Banc de Sang i Teixits, Edifici Dr. Frederic Duran i Jordà, Passeig Taulat, 116, 08005 Barcelona, Spain.|Chair of Transfusion Medicine & Cellular & Tissue Therapies, Universitat Autònoma de Barcelona, Campus UAB, Cerdanyola del Vallès, 08193 Bellaterra, Spain.
authors: Joan
authors: J
authors: García-López
authors: Divisió de Teràpies Avançades/XCELIA, Banc de Sang i Teixits, Edifici Dr. Frederic Duran i Jordà, Passeig Taulat, 116, 08005 Barcelona, Spain.
authors: Irene
authors: I
authors: Oliver-Vila
authors: Divisió de Teràpies Avançades/XCELIA, Banc de Sang i Teixits, Edifici Dr. Frederic Duran i Jordà, Passeig Taulat, 116, 08005 Barcelona, Spain.
authors: Joaquim
authors: J
authors: Vives
mesh_terms: D064987:Cell- and Tissue-Based Therapy / Q000592:standards*; D003132:Commerce; D003201:Computers; D004345:Drug Industry / Q000592:standards*; D006801:Humans; D044968:Regenerative Medicine / Q000592:standards*; D017749:Total Quality Management
keywords: Failure Mode Effects Analysis; Ishikawa; academic institution; cell therapy; computerized system; good manufacturing practice; qualification; validation