In Dec. 2010, the FDA has stepped up enforcement for 21 CFR 11 compliance with spreadsheets being considered as low hanging fruit for FDA inspectional findings.Spreadsheet Applications such as MS Excel are frequently used in 21 CFR 11 compliant environments, but they were not specifically designed for regulated environments and their development is not optimized for 21 CFR 11 compliance. However, the FDA expects that spreadsheets be compliant and lack of compliance can result in a warning…See More
The business of managing risk is changing. Take advantage of this opportunity to examine best practices, discuss trends, learn new technologies, and much more, as ASSE (the American Society of Safety…Continue
A member of my association (the American Society of Safety Engineers) asks for information on the following:I have heard cloud computing may have greater risk for third party subpoenas and government…Continue
OSHA has won another round in its bid to expand its enforcement power, underscoring the need for employers and insurance companies to be careful not to dig a hole for themselves when they conduct…Continue
Started by David Green. Last reply by Lukeav - Lanier Upshaw Jun 14, 2011.
Invitation to apply for ISQEM Director This is your chance to raise you own professional profile in the HSQE industry by becoming a Director of ISQEM, and help increase our membership worldwide. If…Continue