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New EU GMP Annex 11:

General

Project Phase

Operational Phase

Table 1: Risk based Approach

Table 2: Suppliers and Service Providers

Table 3: Comparison of Annex 11 versions

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Table 2: Suppliers and Service Providers Section
Current annex 11:  
When outside agencies are used to provide a computer service, there should be a formal agreement including a clear statement of the responsibilities of that outside agency (see Chapter 7).

System
18
Annex 11-01-2011:  
3.1 When third parties (e.g. suppliers, service providers) are used e.g. to provide, install, configure, integrate, validate, maintain (e.g. via remote access), modify or retain a computerised system or related service or for data processing, FORMAL AGREEMENTS MUST EXIST between the manufacturer and any third parties, and these agreements should include clear statements of the responsibilities of the third party. IT-DEPARTMENTS SHOULD BE CONSIDERED ANALOGOUS.

General
3. Suppliers and Service Providers
3.2 The competence and reliability of a supplier are key factors when selecting a product or service provider. The need for AN AUDIT should be based on a risk assessment.

 
3.3 Documentation supplied with COMMERCIAL OFF-THE-SHELF PRODUCTS should be reviewed by regulated users to check that USER REQUIREMENTS ARE FULFILLED.

 
3.4 Quality system and AUDIT INFORMATION RELATING TO SUPPLIERS OR DEVELOPERS OF SOFTWARE AND IMPLEMENTED SYSTEMS SHOULD BE MADE AVAILABLE TO INSPECTORS ON REQUEST.