ISPE GAMP Good Practice Guide: Global Information Systems Control and Compliance

For processes that are conducted at multiple sites, there are clearly advantages to all participants using the same suite of software systems. The implementation of these multi-site computer systems can be very difficult, and for regulated systems, validation issues add an extra layer of complication.

The GAMP® Good Practice Guide: Global Information Systems Control and Compliance considers major issues that confront companies validating a multi-site computerized system. This Guide aims to assist in the efficient and effective development, implementation, and maintenance of these systems and addresses compliance with international pharmaceutical regulations and guidelines. It covers:

• new systems and extensions to existing ones
• existing validated systems to be maintained

The main body of the GAMP® Good Practice Guide: Global Information Systems Control and Compliance is divided into four main sections:

• Project Management
• Validation and Implementation
• Global Systems Management
• Data Management

The appendices provide additional material and guidance to assist in the identification of regulations, issues, and topics that should be considered.

References are provided to supporting information available in other GAMP guidance. This Guide is intended as a supplement to GAMP 4, and provides more specific detail where additional information is not already available in GAMP 4.

Published:

11/01/2005

ISBN(s):

1931879435

Number of Pages:

92