MHRA published a revision to their 2015 Data Integrity Guidance, finalizing the draft revision published for consultation in 2016. The MHRA Inspectorate blog says that the health authority received over 1300 comments during the consultation process. The revision was a coordinated effort among the GCP, GDP, GLP, GMP and GPvP inspection groups reflecting a broad source of input. MHRA specifically, however, excluded devices from the scope of this guidance. Regarding alignment with guidance from other health authorities, MHRA states: “The GXP data integrity guidance has a high degree of alignment with documents published by other regulators such as PIC/S, WHO, OECD (guidance and advisory documents on GLP) and EMA. It is designed to facilitate compliance through education, whilst clarifying the MHRA’s position on data integrity and the minimum expectation to achieve compliance.” READ MORE… 作者: 轰天乌驹 时间: 2018-7-5 11:00
自己看了了半天,好多没看明白,看看大咖的成果学习一下作者: y00010w 时间: 2018-7-7 16:56
谢谢分享资料。。作者: lijnwi 时间: 2018-7-10 16:22