Scope of validation
Validation requires an appropriate and sufficient infrastructure including:
- organization, documentation, personnel and finances
Involvement of management and quality assurance personnel
Personnel with appropriate qualifications and experience
Extensive preparation and planning before validation is performed
A specific programme for validation activities in place
Validation done in a structured way according to documentation including procedures and protocols.
5.2 Scope of validation
5.2.1 There should be an appropriate and sufficient system including organizational structure and documentation infrastructure, sufficient personnel and financial resources to perform validation tasks in a timely manner. Management and persons responsible for quality assurance should be involved.
5.2.2 Personnel with appropriate qualifications and experience should be responsible for performing validation. They should represent different departments depending on the validation work to be performed.
5.2.3 There should be proper preparation and planning before validation is performed. There should be a specific programme for validation activities.