TABLE OF CONTENTS The system description is an approved and controlled document that outlines the main elements of the CDS system, what it does and who uses it.
Why do we need a system description? The simplest answer is that it is a regulatory requirement! In European Union GMP27, OECD GLP Guidance28 and the new PIC/S Guidance for Inspectors on Computerised Systems in GXP Environments31 there are the following requirements and statements on a system description:
Clause 427:
A written detailed description of the system should be produced (including diagrams as appropriate) and kept up to date. It should describe the principles, objectives, security measures and scope of the system and the main features of the way in which the computer is used and how it interacts with other systems and procedures.
Section 8.528
For each application there should be documentation fully describing:
The name of the application software or identification code and a detailed and clear description of the purpose of the application.
The hardware (with model numbers) on which the application software operates.
The operating system and other system software (e.g. tools) used in conjunction with the application.
The application programming language(s) and/or database tools used.
The major functions performed by the application.
An overview of the type and flow of data/database design associated with the application.
File structures, error and alarm messages, and algorithms associated with the application.
The...
