Regulatory Focus™ > News Articles > FDA To Contract Laboratory: Change Your Password

FDA To Contract Laboratory: Change Your Password

Posted 01 March 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) wants companies to know that having a login name and password to access the company intranet is great-so long as every employee in the company doesn't use the same one.

A warning letter to Biochem Laboratories released 17 February by FDA notes this exact problem, along with FDA's concern that the lack of account ownership could lead to data integrity issues.

"All employees in your firm used the same username and password. In addition, you did not document the changes made to the software or data stored by the instrument systems. Without proper documentation, you have no assurance of the integrity of the data or the functionality of the software used to determine test results," wrote FDA.

While Biochem wrote back to FDA saying that it had fixed the problem, FDA found additional concerns with data backup procedures and unfit computer systems.


Read more:

Outsourcing Pharma - FDA hits lab with warning letter for using one login for all staff

FDA Warning Letter - Biochem Laboratories Inc. 2/17/12


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