Day

August 6, 2015
Mylan.Product: pharmaceutical manufacturing facility Date: 8/6/2015 Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel can change master production and control records, or other records (21 CFR 211.68(b)). Your Siemens computer-based BMS and NVPMS do not require passwords to access the network and servers. Your contractors?...
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

+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TN) and Italy.