Eurotherm "Self-Healing" Data Archiving with "Store and Forward"
Learn more about Data Integrity.ashx?h=3738&la=en&w=5600&hash=EE70BE59FA0EA5683238F20F9C6CD701BD977B25)
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 te quality of electronic records in the Life Science industry.
Data Integrity is an important part of any production quality requiremen on the GMP (Good Manufacturing Practice) environment.
Therefore, in the 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.
Self-Healing data archiving with "Store and Forward" feature
Eurotherm recording products record data at the point of measurement for archiving later, reducing the risk of data loss if the server or communications are temporarily lost. When used in harmony with a historian server, the Eurotherm Store and Forward feature aids reliability of archiving, by reconciling any missing data to storage databases when communications are resumed. This supports the ALCOA+ data integrity concept by providing original, attributable data that is contemporaneous, consistent, and complete.Eurotherm "Store and Forward" feature
Typically, long-term historian data is written to a computer server, but loss of communications with a measuring device can cause a loss of data in production batch or on the Environmental Monitoring System.
The concept of Store and Forward fills these gaps in the collected data by using the Historical Raw Data and Audit Trail stored locally on a measuring device.
The local historical Raw Data, Meta-Data and Audit trail are forwarded to the Historian server and used to replace any gaps in collected data by extracting data contained in the Tamper Resistant recording (.UHH) files and writing it to the database.
Examples of how Eurotherm data management solutions address the requirements of ALCOA+ guidelines:
Missing data in Historian caused by
- Communications failure
- PC failure
- Historian failure
Normal
- Process value and audit trail sent directly to central historian such as Eurotherm INSQL
Store, forward and reconcile
- Identify missing data period
- Retrieve data from tamper-resistant data file (.UHH) directly from the Eurotherm device
- Reconcile Historian with the missing data
T2750 PAC provides
- Dual redundant data acquisition
- Tamper-resistant .UHH file created and stored at local level
Discuss your needs and regulatory requirements with a Life Sciences specialist
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