Eurotherm ‘Self-Healing’ Data Archiving with “Store and Forward”

Helping to improve the reliability of data archiving

Global agencies such as the WHO (World Health Organization), FDA (Food and Drug Administration), EMA (European Medicine Agency), and associations such as PIC/S (Pharmaceutical Inspection Co-operation Scheme), and the ISPE (International Society for Pharmaceutical Engineering), have established a consensus on Data Integrity guidance to manage the quality of electronic records in the Life Science industry.

Data Integrity is an important part of any production quality requirement on the GMP (Good Manufacturing Practice) environment.

Therefore, in regard to the ALCOA+ concept argument “ACCURATE” and “CONSISTENT” loss of any data resulting in gaps in the historic information is not acceptable for any production batch and any measurement on the Environmental Monitoring System.