processing, formal agreements must exist between the 18 When outside agencies are used to provide a computer existing manufacturer and any third parties, and these agreements service, there should be a formal agreement including a requirements; should include clear statements of the responsibilities of clear statement of the responsibilities of that outside Updating text to the third party. IT-departments should be considered agency (see Chapter 7). developing analogous. computer 3.2 The competence and reliability of a supplier are key technology factors when selecting a product or service provider. The standards 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. Validation 2. The extent of validation necessary will depend on a Clarification of number of factors including the use to which the system is requirements; 4.1 The validation documentation and reports should to be put, whether it is prospective or retrospective and cover the relevant steps of the life cycle. Manufacturers Providing whether or not novel elements are incorporated. Validation should be able to justify their standards, protocols, further detail on should be considered as part of the complete life cycle of a acceptance criteria, procedures and records based on existing computer system. This cycle includes the stages of their risk assessment. requirements; planning, specification, programming, testing, commissioning, documentation, operation, monitoring and 4.2 Validation documentation should include change Updating text to changing. control records (if applicable) and reports on any developing deviations observed during the validation process. computer 3. A written detailed description of the system should be technology and produced (including diagrams as appropriate) and kept up 4.3 An up to date listing of all relevant systems and their standards to date. It should describe the principles, objectives, GMP functionality (inventory) should be available. security measures and scope of the system and the main
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. 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. 18 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). existing requirements; Updating text to developing computer technology standards Validation 4.1 The validation documentation and reports should cover the relevant steps of the life cycle. Manufacturers should be able to justify their standards, protocols, acceptance criteria, procedures and records based on their risk assessment. 4.2 Validation documentation should include change control records (if applicable) and reports on any deviations observed during the validation process. 4.3 An up to date listing of all relevant systems and their GMP functionality (inventory) should be available. 2. The extent of validation necessary will depend on a number of factors including the use to which the system is to be put, whether it is prospective or retrospective and whether or not novel elements are incorporated. Validation should be considered as part of the complete life cycle of a computer system. This cycle includes the stages of planning, specification, programming, testing, commissioning, documentation, operation, monitoring and changing. 3. 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 Clarification of requirements; Providing further detail on existing requirements; Updating text to developing computer technology and standards
consult-manuf-automatic-adoption-pics-130529-comparison.docx