Product category:
Telemetry, data acquisition + loggers
News Release from: ABB Automation Tech (Instrumentation + Automation) | Subject: InformIT SM Series
Edited by the Processingtalk Editorial
Team on 27 January 2003
Videographic recorders for 21CFR Part 11
use
The ABB InformIT SM Series Videographic Recorders now have documentation detailing their compliance with the FDA 21 CFR Part 11 regulations concerning the use of electronic recorders for process data
Food and Drug Administration (FDA) 21 CFR Part 11 lays down stringent requirements for the use of videographic recording equipment aimed at safeguarding data security Key requirements under the regulations include the ability to prevent unauthorised tampering and ensure data validity
This article was originally published on Processingtalk on 20 Jul 2004 at 8.00am (UK)
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ABB InformIT SM1000 and SM2000 recorders incorporate a number of advanced security features to ensure data integrity in line with 21 CFR Part 11.
These features include restricted access to the smart cards used to record process data.
To prevent tampering with the recorders, four individual users can be configured and allocated with their own password.
As an extra layer of security, the recorders also feature an internal security switch protected by a tamper-proof seal preventing unauthorised personnel from making changes to the configuration of the recorder.
Throughout operation, all system events are logged by an internal audit trail, which records the details of any changes made to the configuration of the unit, including who made them and when, as well as logging all datafiles created and many other events key to process data security.
Added measures to protect the security of archived data are also included in the ABB DataManager analysis software, which enables users to easily download and analyse process data files recorded by an InformIT SM series recorder.
All files created are attributed an encrypted digital signature, which is then used by DataManager to check the integrity of the recorded data.
ABB InformIT SM Series is designed for applications in the food, dairy, brewing, pharmaceuticals, water treatment, power generation and plastics and rubber industries and provides an easy migration from paper charts to all-electronic recording on the process.
The recorders feature up to 12 recording channels, IP66 and NEMA 4X front face protection for use in harsh locations and 'state-of-the-art' internal flash memory, as well as operator-friendly Windows-based controls and dialogues.
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