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

【摘要】：正CDSER(Centre for Drug Safety Evaluation and Research) perform GLP Toxicology studies according to SFDA,FDA,Japan and OECD guidelines.To help achieve this,the Provantis Computerised System for Toxicology Data Management,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 Oracle databases(Production,Training and Validation),Citrix Windows Terminal Servers and Fileshare which are accessed via virtual private network from CDSER.CDSER IS Team qualified the required infrastructure at CDSER prior to use with Provantis,with support from AstraZeneca IS.②The implementation of Provantis was done as a combined effort between CDSER and AstraZeneca as part of the Alliance between the 2 parties.Expert Users from each area were identified(Protocol Reporting,In-Life,Clinical Pathology and Pathology),and worked closely with Instem and IS representatives from CDSER 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 validation package and maintenance.④Creating dual language for Clinical Observations and Pathology findings so that the data could be collected and also reported in either Chinese or English,depending on where the study reports are to be submitted.⑤CDSER Expert Users performed user acceptance testing covering all areas in the Validation environment and then Operational Qualification testing before the system was used live in the Production environment.⑥There are four steps to start using Provantis in a GLP study:a) Standard training process and controlled procedure for new user to get 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,incident report and change control processes were established and controlled,and d) Version controlled SOPs and User Manuals were in place.