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Labcompliance News, April 2001

April 06, 2001

FDA Warning Letter on Analytical Equipment Calibration and Validation of Software

In October 2000 the FDA issued a warning letter to an analytical laboratory citing deviations of equipment calibration and validation of software: "The software programs have not been verified or validated". The fact that the laboratory had developed a software validation schedule did not help: "You indicate that you will develop a complex software validation schedule in cooperation with the software vendor by December 31. However, the validation schedule will not be approved until January 21, 2001, and the software validation exercise will not be completed until June 30, 2001. It appears that you are proposing to continue to use these … systems for testing of … without having completed the calibration of … or validation of its software. This is unacceptable". The FDA expects products and software with high impact on product quality to be validated now. In response to this we have developed a presentation entitled "Operational Compliance for Legacy Systems" with more examples of deviations and a nine step implementation plan. This presentation as well as the full warning letter and an SOP on "Retrospective Evaluation and Validation of Existing Analytical Systems" can be downloaded from the LabCompliance User Club.

April 06, 2001

ISO 9000:2000 Available On-line

The ISO 9000:2000 series quality management standards can be purchased online from techstreet.com. Advantage is immediate delivery and search capability of the electronic file. The standard is being published on December 15, 2000, It has been approved and is now official.