Common use of Device History Record Clause in Contracts

Device History Record. The Supplier and Customer will agree on which party maintains selected portions of the Device History Record required by 21 CFR §820.181. This list also includes installation reports (21 CFR §820.170) and servicing reports (21 CFR §820.200). • Record Applicable Supplier Customer Specific Records • Device specifications • Production process specifications • Quality assurance procedures and specifications • Labeling specifications • Packaging specifications • Installation procedures and methods • Installation records • Maintenance procedures, methods, and Records • Servicing procedures, methods, and records Upon the request of the Customer, the Supplier shall make all records available within two working days.

Device History Record. The Supplier and Customer will agree on which party maintains selected portions of the Device History Record required by 21 CFR §820.181. This list also includes installation reports (21 CFR §820.170) and servicing reports (21 CFR §820.200). • The responsibilities are defined in the following table. Record Applicable Supplier Customer Specific Records • Device specifications • Production process specifications • Quality assurance procedures and specifications • Labeling specifications • Packaging specifications • Installation procedures and methods • Installation records • Maintenance procedures, methods, procedures and Records • methods Maintenance records Servicing procedures, methods, procedures and methods Servicing records Upon the request of the Customer, the Supplier shall make all records available within two working days.