Compliance

Enterprise labeling is a term that refers to a labeling management solution which can include label design, review, and controlled revision with printing capabilities across multiple global locations. An enterprise labeling system that is designed for the life sciences must accomplish all of the above but in addition, it must comply with the provisions of

Automatic identification and data capture (AIDC), also known as auto-ID and automatic data capture refers to the process of acquiring data by means of electronically analyzing images, videos or sounds. The data is captured then converted to a digital representation. Several different types of technology are used to accomplish AIDC, including:

General medical device labelling requirements are outlined in the FDA’s 21 CFR Part 801. This documentation outlines the minimum requirements for all medical devices. Here is an abbreviated rundown on the 5 most common medical device labeling requirements.

10 Things to Know 21 CFR Part 11 is a section of Title 21 of the Code of Federal Regulations that authorizes the U.S. FDA rules and regulations related to electronic records and electronic signatures (ERES). It outlines the criteria which designate ERES to be a reliable equivalent to paper records. Here are ten important