Common use of Qualification/Validation Clause in Contracts

Qualification/Validation. Equipment qualification, process validation, analytical methods validation and validation of computerized systems, if used, are in place and covered by Change Control. Validation documentation shall be available for review during an audit. On request, the Client will get copies or summaries from the process validation reports. Development (Early clinical phase) Supplier’s equipment qualification and Change Control process are in place. Verification of analytical methods for intended use (see Note).

Qualification/Validation. Equipment qualification, process validation, analytical methods validation and validation of computerized systems, if used, are in place and covered by Change Controlchange control. Validation documentation shall be available for review during an audit. On request, the Client CONTRACT GIVER will get copies or summaries from the process validation reports. Development (Early clinical phase) Supplier’s equipment qualification and Change Control process are in place. Verification of analytical methods for intended use (see Note).