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Visit the Eurotherm dedicated Life Sciences site

 

 

21 CFR Part 11 Compliant Data Archiving

with

Secure Electronic Batch Records

and “Store & Forward”

Secure Electronic Recording Control and monitoring of storage and production environments has become an important issue within the Pharmaceutical Industry. The FDA, EMEA and other regulatory bodies require accurate measurement and storage of room parameters and, if the storage medium is electronic, the methods used must comply with 21 CFR Part 11. In addition to meeting the exacting requirements of generating FDA compliant records, Eurotherm solutions provide significant benefits by including redundant logging with “Store & Forward” security. This ensures that data integrity is maintained through the implementation of fault tolerant features.

 

 

 

 

 

Data Security

 

 

 

Store & Forward

 

 

Multiple Connectivity

 

Dynamic Reporting

 

 

Store & Forward is a self healing 21 CFR Part 11 data 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 secure electronic recording with total data integrity.
 

 

Logging options

Time based

■ Continuous trace 

■ 21 CFR Part 11

Compliant 

■ Signed audit trails 

■ Batch

■ Start/stop

■ Continuous

(Sub phases or sub  

batches)

 
 

Logging parameters

Time based PV

(Actual max, min, average)

For example:

■ Temp  ■ Rh  ■ Pressure 

■ Speed  ■ Ph  ■ MKT

... plus any other process parameter

Event based

■ Channel Alarms  ■ Batch start/stop 

■ User event messages 

■ Operator actions

■ Operator notes  ■ Electronic signatures

■ Log in/log out

 

Data Presentation

■ Trend chart and

spreadsheet based

■ Absolute or relative time

■ Batch or Sub Batch data

search by:

■ Absolute date & time   

■ Relative date & time

■ Batch name

■ Sub Batch name

 		  
 
 

Data Security

■ 21 CFR Part 11 compliant binary

encoded read-only files

■ Auto-FTP to server

■ Secure embedded audit trails

■ Electronic signing and authorising

  

Secure batch release

■ Operator signed and authorised

batch and continuous records

■ Reviewed

■ Approved

■ Released

  
 
 

 

 

If you would like to contact your local Eurotherm Life Sciences engineer click here

 

To visit the Eurotherm WebStore click here

 

Literature downloads:

 

  

Eurotherm Ltd

  

Eurotherm Ltd

Faraday Close, Durrington,

Worthing, West Sussex BN13 3PL,

UNITED KINGDOM

 

T: +44 (0) 1903 268500

F: +44 (0) 1903 265982

E: info.uk@eurotherm.com