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Validation and implementation of Provantis ~Computer System in GLP facility

HU Miao-miao  YU Hong  Elaine GORDON  QIN Qiu-ping  QIAO Jun-wen  JING Yi  LU Jing  REN Jin  
【摘要】:CDSER(Centre for Drug Safety Evaluation and Research)perform GLP Toxicology studies according toSFDA,FDA,Japan and OECD guidelines.To help achieve this,the Provantis Computerised System for Toxicology DataManagement,Collection and Reporting has been implemented to manage the data electronically since 2011 at CDSER.There are some experiences from us:①A hosted environment is used and provided by the vendor,Instem,including Or-acle databases(Production,Training and Validation),Citrix Windows Terminal Servers and Fileshare which are accessedvia virtual private network from CDSER.CDSER IS Team qualified the required infrastructure at CDSER prior to use withProvantis,with support from AstraZeneca IS.②The implementation of Provantis was done as a combined effort betweenCDSER and AstraZeneca as part of the Alliance between the 2 parties.Expert Users from each area were identified(Pro-tocolReporting,In-Life,Clinical Pathology and Pathology),and worked closely with Instem and IS representatives fromCDSER and AstraZeneca.The Expert Users identified business user requirements and working practices for their areas.③Documentation from AstraZeneca was used as templates and amended to match CDSER needs,including whole vali-dation package and maintenance.④Creating dual language for Clinical Observations and Pathology findings so that thedata could be collected and also reported in either Chinese or English,depending on where the study reports are to besubmitted.⑤CDSER Expert Users performed user acceptance testing covering all areas in the Validation environmentand then Operational Qualification testing before the system was used live in the Production environment.⑥There arefour steps to start using Provantis in a GLP study:a)Standard training process and controlled procedure for new user toget access into the system,b)Training program was used with CDSER Expert Users training the other CDSER users,and a modified training package was then established and it is used regularly,c)System maintenance including library,in-cident report and change control processes were established and controlled,and d)Version controlled SOPs and UserManuals were in place.

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