技術資料：バイオ医薬品におけるデータインテグリティ - Genedata BioprocessによるALCOA++原則への対応

ALCOA++ is a set of principles that guarantee data integrity in the pharmaceutical sector introduced by the FDA and represents the highest standards of data integrity in regulated GxP environments. To facilitate data integrity, the adoption of ALCOA++ principles is key — as is using a data management system with the required compliance functionalities in place. 

Genedata Bioprocess^® ensures data integrity and enables full compliance in bioprocess development across biopharma, biotech, as well as contract research, development, and manufacturing organizations (CROs, CDMOs). Specific design and control elements and out-of-the-box functionalities in the platform address ALCOA++ requirements and support compliance, streamlining development of originator drugs and biosimilars.