EU Guidelines

EU Guidelines For Computerized System Part- 2

Quality Assurance

Project Phase Validation4.1 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 …

EU Guidelines For Computerized System Part- 2 Read More »

EU Guidelines For Computerized System Part -1

Quality Assurance

PrincipleThis annex applies to all forms of computerised systems used as part of a GMP regulated activities. A computerised system is a set of software and hardware components which together fulfill certain functionalities.The application should be validated; IT infrastructure should be qualified.Where a computerised system replaces a manual operation, there should be no resultant decrease …

EU Guidelines For Computerized System Part -1 Read More »