March 22, 2018
The deadline to comply with the EU General Data Protection Regulation (GDPR) is May 25, 2018. Are you ready? If you're a life sciences company, the key is to leverage the controls and practices that you should already have in place.
August 30, 2017
Validation regulatory requirements are driven by regulations such as FDA 21 CFR Part 11, EU Annex 11 and many other country specific requirements for validation.
January 25, 2017
Much has been written about validating equipment, instruments, and computer systems. Add articles written about 21 CFR Part 11 to the pile and you become engulfed in a titlewave of information.