Data Integrity Deviations And Shop Floor Quality | 美體產業公開資訊

2018年6月15日—Havingstafffromthequalityassurance(QA)functionpresentoreasilyaccessibletoallshiftsandoperationsinaproductionfacilitymayimprove ...

By Kip Wolf, X-Vax Technology, @KipWolf[1][2]

Continuous improvement in data integrity can advance a firm on the journey toward a mature culture of quality, particularly through the implementation of QA on the shop floor. Batch record review (BRR) and product disposition are often complicated by data integrity issues and poor data quality. The process of BRR and product disposition is made further complex by production deviations and investigation of quality events, adding to the volume of data that must be reviewed and resolved in order to facilitate product disposition. The ISPE GAMP® Guide for Records and Data Integrity (p. 34) states that “data creation should provide accurate data which is needed throughout the business process for decisions based on that data,” one example of which is where production data is necessary to inform BRR and product disposition.  

Improved Dat...