Glossary

A form used by the FDA to report inspectional observations.

A weighing device used in laboratories.

A method of identifying an individual's identity based on measurement of the individual's physical feature(s) or repeatable action(s) where those features and/or actions are both unique to that individual and measurable.

A form used in clinical trials by a physician to report findings made during patient visits.

Media that is intended to be permanent.

Any combination of text, graphics, data, audio, pictorial, or other information represented in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.

A computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individuals signature.

A method of encoding data in order to preserve the integrity of the data.

A term that includes GLPs, GMPs and GCPs.

The scripted name or legal mark of an individual handwritten by that individual with the present intention to authenticate a writing in permanent form.

A system that uses handwritten signatures in conjunction with electronic records.

Laboratory Information Management System.

Data about the data in an electronic record. This might include system configuration parameters, audit trails, file properties, or formulas in an Excel spreadsheet.

A method of identifying an individual's identity based on at least two distinct identification components such as identification code and password. Requires that at least one component be known only to the individual. The combination must be unique.

The underlying FDA Regulations (GLPs, GMPs, and GCPs that govern activities in the life sciences industry.

An interpretation that states that when a computer system that creates the information in an electronic record is used simply as a typewriter (i.e., only to print out information onto paper), then the record is not considered an electronic record.

A letter issued by the FDA when they feel that a company has not satisfactorily corrected any noncompliance issues previously cited in a 483.