Day

January 12, 2011
Recipient: Verichem Laboratories Inc.Product: clinical chemistry reference materials for in-vitro diagnostic (IVD) use Date: 12/16/10 1. Failure to validate the design under defined operating conditions and by using initial production units, lots, batches, or their equivalents, as required by 21 CFR 820.30(g). b) Your firm failed to perform design validation for the data analysis software...
Read More

CSV Training Course

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

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.