[ITG by FDA] The Computer in FDA Regulated Industries

Pharmacy / Pharmaceuticals:

Pharmacy (general category)

Life cycle of medicinal products and medical devices:

Validation, qualification

Medical devices / equipment:

Medical devices / equipment (general category)

Resource type:

guideline / guidancewebsite of an authority

Language:

[EN] English

Report

Added by: Ekaterina Chashnikova

Description

This ITG is the first of a series of ITGs intended to aid the Investigator in understanding computerized operations. The approach will be a simplified explanation of the basic principles of the computer with later ITG issues covering such areas as programming and details of computer operation and specific applications.

Comments