卡狄亞：制藥企業質量管理體系審核現場實錄

本期文章是由卡狄亞小編為大家講解制藥企業質量管理體系審核現場實錄

近日卡狄亞審核員前往張江藥谷平臺對上海愛譜蒂康生物科技有限公司進行ISO9001質量管理體系審核。上海愛譜蒂康生物科技有限公司成立于2021年8月，擁有國際一流的研發平臺和團隊。公司以蛋白質組學技術為核心，建立了工業級多組學研發與驗證平臺、伴隨診斷與診斷試劑開發平臺、醫藥分析技術平臺。借助三大平臺，將臨床多組學海量大隊列數據與大數據模型分析相結合，為疾病的精準診斷與治療探索出了一條全新的道路，形成了從新藥物靶點發現到臨床伴隨診斷，直至創新藥物研發的診療全產業鏈應用技術服務。公司不僅通過了中國合格評定國家認可委員會C娜斯的實驗室認可也榮獲ISO9001質量管理體系認證愛譜蒂康擁有頂尖的技術團隊、優秀的營銷團隊，還具備充足的測試方法開發經驗及服務經驗。體系認證提升了企業的管理水平和運營效率，增強了客戶信任，為企業贏得了更多的市場機會。

Recently, Cardia auditors went to Zhangjiang Pharmaceutical Valley platform to conduct an ISO9001 quality management system audit on Shanghai Apticorn Biotechnology Co., Ltd. Shanghai Aptikang Biotechnology Co., Ltd. was established in August 2021 and has a world-class research and development platform and team. The company has established an industrial grade multi omics research and validation platform, a companion diagnosis and diagnostic reagent development platform, and a pharmaceutical analysis technology platform with proteomics technology as the core. With the help of three major platforms, a new path has been explored for precise diagnosis and treatment of diseases by combining massive clinical multi omics data with big data model analysis. This has formed a full industry chain application technology service for diagnosis and treatment, from the discovery of new drug targets to clinical accompanying diagnosis, to innovative drug development. The company has not only passed the laboratory accreditation of China National Accreditation Service for Conformity Assessment (CNAS), but also obtained ISO9001 quality management system certification. Apticorn has a top-notch technical team, excellent marketing team, and sufficient experience in testing method development and service. System certification has improved the management level and operational efficiency of enterprises, enhanced customer trust, and won more market opportunities for enterprises.

m.jglocqr.cn