2009-2011 FDA 警告信.docxVIP

2009–2011年FDA警告信涉及HPLC的内容1. Raw Data / Protection of Electronic Records?电子记录的原始数据/保护Your firm lacks systems to ensure that all electronic data generated in your Quality Control laboratory is secure and remains unaltered. All analysts have system administrator privileges that allow them to modify, overwrite, and delete original raw data files … in the High Performance Liquid Chromatography (HPLC) units.贵公司缺乏系统以确保所有的在质量控制实验室产生的电子数据是安全的并保持不变。你们HPLC岗位所有的分析员都具有系统管理员的权限去修改，覆盖并删除原始数据。There are no procedures that address the security measures in place for generation and modification of electronic data files for these instruments used for raw material, in-process,finished product and stability testing. In addition, your firms review of laboratory data does not include a review of an audit trail or revision history to determine if unapproved changes have been made.?没有建立一个程序规定如何对原材料、中间控制、成品和稳定性测试的电子文件进行安全保存和修改。贵公司的实验室数据审查并不包括审计跟踪或未经批准修改数据的历史记录审查。For example,your firm has failed to periodically conduct back-up procedures This server was used to store, back-up, and/or archive raw test data from computer systems (Software:…controlling and monitoring… High-performance liquid chromatography (HPLC) systems in accordance to SOP …”.例如贵公司未能按SOP的要求对服务器上存贮的原始数据进行定期备份。Your response, however, is inadequate because you fail to adequately address whether you were able to recover the critical data not backed-up between August 2010 and when you first implemented the daily backup process. Your firm has yet to indicate whether HPLC raw data records could be retrieved for the duration of time that the … server was not backing-up the HPLC system data.你们的回复是不适当的，因为你们不能充分叙述2010年8月是否对关键数据进行了备份，2010年8月是你们第一次执行备份程序。贵公司还不能表明能否找到那段时间的HPLC原始数据，…服务器不支持备份HPLC系统数据。Your firms laboratory analysts have the ability to access and delete raw chromatographic data located on the … of … used to conduct HPLC testing. Due to this unrestrictive access, there is no assurance that laboratory records and raw data are accur