Common use of Validation Services Clause in Contracts

Validation Services. For clients required to comply with FDA 21CFR Part 11, DocXellent provides services to establish proper requirements, installation and functionality qualification documentation and evidence inclusive of a User Requirements Specification, Traceability Matrix, Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) as well as Deviation and Validation Summary Reports. For Cloud clients, these services are included in Cloud pricing. Additional Client initiated validation services that not part of the standard DocXellent provided services can be considered on an as-needed basis and may be subject to further quotation.

Validation Services. For clients required to comply with FDA 21CFR Part 11, DocXellent provides services to establish proper requirements, installation and functionality qualification documentation and evidence inclusive of a User Requirements Specification, Traceability Matrix, Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) as well as Deviation and Validation Summary Reports. For Cloud clients, these services are included in Cloud pricing. For on- premises clients, these are optional services that can be provided if requested. Additional Client initiated validation services that not part of the standard DocXellent provided services can be considered on an as-needed basis and may be subject to further quotation.