卡狄亚：制药企业质量管理体系审核现场实录

本期文章是由卡狄亚小编为大家讲解制药企业质量管理体系审核现场实录

近日卡狄亚审核员前往张江药谷平台对上海爱谱蒂康生物科技有限公司进行ISO9001质量管理体系审核。上海爱谱蒂康生物科技有限公司成立于2021年8月，拥有国际一流的研发平台和团队。公司以蛋白质组学技术为核心，建立了工业级多组学研发与验证平台、伴随诊断与诊断试剂开发平台、医药分析技术平台。借助三大平台，将临床多组学海量大队列数据与大数据模型分析相结合，为疾病的精准诊断与治疗探索出了一条全新的道路，形成了从新药物靶点发现到临床伴随诊断，直至创新药物研发的诊疗全产业链应用技术服务。公司不仅通过了中国合格评定国家认可委员会C娜斯的实验室认可也荣获ISO9001质量管理体系认证爱谱蒂康拥有顶尖的技术团队、优秀的营销团队，还具备充足的测试方法开发经验及服务经验。体系认证提升了企业的管理水平和运营效率，增强了客户信任，为企业赢得了更多的市场机会。

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.

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