Streamlining the qualification of computerized systems in GxP-compliant academic cell therapy facilities ANNA DEL MAZO-BARBARA 1 , VALENTÍN NIETO 2 , CLÉMENTINE MIRABEL 1 , BLANCA REYES 1 , JOAN GARCÍA-LÓPEZ 1,3 , IRENE OLIVER-VILA 1 & JOAQUIM VIVES 1 1 Divisió deTeràpies Avançades, XCELIA, Barcelona, Spain, 2 Àrea Corporativa de Qualitat, Banc de Sang iTeixits, PasseigTaulat, Barcelona, Spain, and 3 Universitat Autònoma de Barcelona, Bellaterra, Spain To the Editor: Compliance with Good Manufacturing Practices (GMP) is mandatory in the development and man- ufacture of advanced therapy medicinal products, pushing academic developers to implement methods for control and monitoring of bioprocess parameters that, until recently, were only found within large cor- porate environments [1]. These methods include computerized systems (CS), which contribute greatly to standardization; improvement of productivity while ensuring conformity of product specifications; removal of unnecessary duplicates; and reduction of downtime and human error. Indeed, the use of CS in the phar- maceutical industry has increased exponentially since the 1990s, and the growing field of cell therapy is no exception to this. The use of CS in public institutions is still limited, however, likely because of budget re- strictions and the perceived complexity in obtaining qualification for information systems. Both American and European regulations devote significant atten- tion to CS [2,3] and consider unqualified CS a serious deviation, particularly if their failure can compromise product quality, and therefore safety and efficacy. Any CS in operation in a GMP-compliant cell therapy facility must be qualified according to its ar- chitecture and validated for use.To achieve this, their acceptance criteria, protocols, procedures and records must be supported based on well-documented risk analyses that serve as the basis for leveraging the rel- ative importance of the validation required, categorized according to the expected use of the CS [4]. The In- ternational Conference on Harmonisation (ICH) defines “risk” as “the combination of the probability of occurrence of harm and the severity of such harm” [5]. Quality Risk Management thus emerges as a methodology to evaluate, monitor, verify and document quality risks throughout a product’s life- time. According to regulatory authorities, Quality Risk Management is increasingly gaining acceptance as a valuable tool for achieving an effective quality system that considers the unavoidable existence of a basal level of risk in the production and commercialization of medicines. Both qualitative and quantitative risk anal- yses are accepted by regulatory agencies, although quantitative data are preferred because they are clearer, more intuitive and unambiguous [5]. Here, we share a simple methodology that com- plies with GMP regulations according to European Medicine Agency’s GMP 11th and 15th Annexes.We believe it is feasible to perform in academic institu- tions, and it has been used in our GMP-compliant cell therapy facility, which was inspected by regulatory authorities in 2010, 2011 and 2014 [1]. The ap- proach presented here contributes to simplifying and streamlining CS qualification in compliance with phar- maceutical standards. Briefly, qualitative and quantitative risk analyses were performed using the Ishikawa and Failure Mode and Effects Analysis (FMEA), respectively, to deter- mine potential causes of errors of the design, as well as installation, operation and performance of CS, based on the likely impact of CS on the specifications of cell- based products for clinical use (Figure 1A,B). First, an Ishikawa diagram is created as a prelim- inary risk analysis aimed at identifying and classifying the main cause(s) of deviation in product specifica- tions.The simplicity of the initial Ishikawa risk analysis permits quick, qualitative identification of critical pa- rameters that are classified in six groups (equipment, Correspondence: Joaquim Vives, MD, Divisió de Teràpies Avançades, Banc de Sang i Teixits, XCELIA, Edifici Dr. Frederic Duran i Jordà, Passeig Taulat, 116, Barcelona 08005, Spain. E-mail: jvives@bst.cat ARTICLE IN PRESS (Received 27 May 2016; accepted 4 June 2016) ISSN 1465-3249 Copyright © 2016 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.jcyt.2016.06.003 Cytotherapy, 2016; ■■: ■■–■■