National Genetics Institute

Recipient: National Genetics Institute.
Product:HIV-1 and Hepatitis C virus nucleic acid tests
Date: 1/17/2006

FDA District:Los Angeles District Office

Failure to validate computer software used in production; failure to validate the quality system; failure to document validation activities and results; failure to make adequate provisions for monitoring laboratory test procedures and instruments; failure to maintain written standard operating procedures; failure to maintain adequate procedures for testing blood and biologics components; failure to maintain process control procedures; and failure to establish an adequate system for authorizing, granting and rescinding computer access to functions

Issuer:Los Angeles District Office

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN) and Italy.