21 CFR PART 11: Complete Manual for Compliance Success

FDA inspectors are ever increasing the number of inspections where they include Part 11 as a part of the scope or THE scope of the inspection. The trends and reports are showing that the FDA inspectors are focusing on electronic signatures and electronic records as more and more companies are implementing systems and technologies to […]

Understanding 21 CFR Part 11 compliance for software validation and SaaS/Cloud

Software as a Service, SaaS is a method of delivering applications over the Internet. This small definition just about summarizes the core of SaaS: It provides Software as a Service using just the Internet. SaaS applications go by different nomenclatures such as on-demand software, hosted software, or web-based software. SaaS is a fundamentally different method […]