AC9000-plus Checkweigher Controller with 21CFR-Part 11



The already expansive feature set of the Thermo Scientific AC9000-plus controller can now be expanded to meet the requirements of the US FDA’s 21CFR-Part 11 relating to electronic signatures. Fully integrated into the controller hardware with no external PC required, this is a cost effective option offering complete traceability for this requirement or for contributing to compliance with the requirements of the 2002 bioterrorism act as it relates to food products. Available in new equipment or as a retrofit to existing AC9000-plus systems.
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The Thermo Scientific AC9 Checkweigher Controller is a state-of-the-art instrument for the measurement and control of packaged weights in the food, pharmaceutical, and consumer industries. The new high security variant of the AC9 addresses one of the outstanding operational issues within these industries. No matter what the performance of a particular checkweigher, the operational efficiency can be greatly impaired, or even negated, by unauthorized changes to its setup.

Based on work in the pharmaceutical industry to meet the stringent FDA requirements for 21 CFR Part 11, the unit requires an authorized user to enter a unique user ID and passcode. Without this electronic signature a user can interrogate the checkweigher information but is unable to make operational changes to the unit.

The system administrators for the checkweigher have various options at their command, which lets them determine how the security system will operate. They can also determine which level of access is available to each authorized user.

Greater security means better brand protection and higher quality standards for the user. For customers who require a full audit trail on their checkweighers, the option to incorporate the full functionality of FDA 21 CFR Part 11 is available.

Particular elements of the option include:

  • All users are defined by the administrator. (min. 7 characters).
  • Users are required to have unique passwords of at least six digits.
  • Passwords can be assigned expiry dates.
  • System can be set to automatically default to ‘protected’ level after some time on inactivity.
  • Users can be automatically disabled if their password is incorrectly entered a number of times.

Audit trail tracks each of the following events:

  • User log-in
  • Password change
  • User change
  • Reset of alarms
  • Clear of statistics
  • Product change
  • Product copy
  • Calibration
  • Speed calibration
  • Manual re-zero
  • Change of any options

Audit records, viewable on-screen, or via export to diskette, include:

  • Date/time of event
  • User ID
  • Event description
  • Variable description
  • Old value
  • New value

See other Checkweigher products at www.thermo.com/checkweighers

 
Purchase Details
SKU : PID-10124472 
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