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Labcompliance News, June 2001

July 23 to Aug 2, 2001

One day seminar
Implementing ISO17025 and GLP/GMP in the Analytical Laboratory

Agilent Technologies,

Singapore, Malaysia, Thailand, Taiwan, Beijing

June 4, 2001

New Validation Master Plan: Rev 2.0

  • The single most important validation document
  • Framework and starting point for all other validation activities
  • Now with 50% more contents, exactly the same price as Rev 1.! (US$ 50.-)
  • Includes network qualification
  • Includes forms and checklists

For more info and ordering information click here

June 1, 2001

What FDA Inspectors Want to See About Computer Validation

At the London Computer Validation Conference of Business Intelligence David Bergeson, gave an interesting presentation on the expectations of FDA inspectors for computer validation. David Bergeson is quite competent to address this topic because he was one of the FDA's experts on computer validation and drafted several FDA documents on this topic. Key recommendations have been to spend more time for setting correct specifications and to stress the system under worst case conditions for functional testing. He also recommended to develop test cases such that they can be easily reused for later requalification.
The presentation can be downloaded from the LabCompliance User Club under computers. 

June 1, 2001

New Guidance on Equipment Qualification of Analytical Instruments:
UV-Visible Spectro(photo)meters

This 22 pages guide has been developed by an expert working group consisting of user and vendor representatives and has been published by LGC/VAM in the UK. It gives advice on the sort of issues that should be considered at each stage of qualification of UV-Visible Spectro(photometers) from purchasing an instrument, through installation qualification and operational qualification to the day-to-day performance checks. The text is supported by an extensive bibliography.

June 1, 2001

New article from R.D.McDowall:
Containing the 21 CFR 11 Problem: Purchase of Non-Compliant Systems

The current emphasis of 21 CFR 11 is on the assessment of legacy systems and their remediation. However, a potential problem is the lack of measures to contain the problem. Organizations are still purchasing non-compliant equipment and systems; what are the steps to be taken to ensure that these new systems will also become compliant? This article will provide the answers.
Download draft version from LabCompliance User Club or order an electronic copy through e-mail.