Global Agencies such as WHO (World health Organization), FDA (Food and Drug Administration), EMA (European Medicine Agency) , Association such as PIC/S (Pharmaceutical Inspection Co-operation Scheme), ISPE (International Society for Pharmaceutical Engineering) established a consensus on the DATA INTEGRITY guidance to manage the Electronic record in the Life Science Market.

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.

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 eliminates 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.

“Store & Forward” is a self-healing archiving system that automatically stores data during a communications failure and then forwards this to the configured server when communications have been reinstated.

This results in Tamper Resistant electronic recording with total DATA INTEGRITY (compliant with the FDA 21CFR Part11).

Normal Operation

  • Process value and audit trail sent directly to Central Historian such as Eurotherm INSQL

Missing Data in Historian caused by

  • Communications failure
  • PC Failure
  • Historian Failure

Store, Forward and Backfill Action

  • Identify missing data period
  • Retrieve data from Tamper Resistant recording (.UHH) directly from the Eurotherm Device
  • Device ATTRIBUTABLE backfill the control Historian with missing data

PAC T2750 provides

  • Dual Redundant Data Acquisition
  • Secure .UHH created and stored at local level

6000 Recorder series and nanodac provides

Tamper Resistant recording (.uhh) created and stored at local level

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