Product category:
Measurement and Quality Software and SPC
News Release from: Labtronics | Subject: Pipette Tracker Pro Version 3.2
Edited by the Manufacturingtalk Editorial
Team on 14 May 2004
Pipette Calibration Meets Compliance
Requirements
Pipette Tracker Pro version 3.2, provides laboratories operating in an FDA regulated environment with the tools that they need to meet 21 CFR Part 11 compliance requirements.
Labtronics has released Pipette Tracker Pro version 3.2, the only pipette calibration software that provides laboratories operating in an FDA regulated environment with the tools that they need to meet 21 CFR Part 11 compliance requirements The security implementation in Pipette Tracker Pro includes: User ID and Password control, Electronic Signatures and an audit trail function that logs all system activity and changes
This article was originally published on Manufacturingtalk on 2 May 2006 at 8.00am (UK)
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Pipette Tracker Pro Meets 21 CFR Part 11
The security implementation in Pipette Tracker Pro includes: User ID and Password control, Electronic Signatures and an audit trail function that logs all system activity and changes.
A workstation can be automatically locked out if left inactive for a specified period of time, preventing undocumented access to an unattended workstation.
Pipette Tracker Pro methods and test plans can be validated and versioned with authorized users only being allowed to use current validated methods and test plans.
Pipette Tracker Pro also fully supports Oracle and SQL Server databases allowing companies using these platforms to implement Pipette Tracker Pro in a manner that meets the requirements and standards of their IT structure.
Pipette Tracker Pro automatically schedules calibration testing for all pipettes.
Pipettes can be setup to appear on a work-list ahead of the testing date to ensure that the pipette is available for testing at the appropriate time or Pipette Tracker Pro can automatically e-mail the pipette operator advising them that calibration is due.
During the calibration test, Pipette Tracker Pro can interface directly with the balances, and environmental monitoring equipment to automatically retrieve each weight and the environmental conditions during the calibrations.
This does away with the need for manual recording of results and eliminates associated errors.
Pipette Tracker Pro can generate a variety of standard or user customized reports.
Pipette Tracker Pro performs all calculations and calibrations in full accordance with international standards including ISO 8655, DIN Standard12650, GLP, ISO 9000 and conforms to the procedures recognized by the National Committee for Clinical Laboratory Standards (NCCLS).
For any laboratory that wants to ensure the accuracy and precision of their pipettes and liquid handling devices, Pipette Tracker Pro is an automation solution that reduces the time and resources required to schedule, perform and document regular in house calibration testing, within a secure environment that meets regulatory compliance requirements.
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