Built upon OakRiver's quality system, our Validation Support Services are designed to assist our health and medical device customers with scaling up a validated manufacturing operation.

OakRiver is well suited to offer additional "down-stream" services such as validation support given our in-depth understanding of the equipment design and Title 21 CFR part 11 compliance.

Validation support services include;

• Documentation support - OakRiver quality system tools
• Design History File
• Design Requirements Document
• Software Requirements Document
• Trace Matrix
• Design Verification Plan (and Results)
• Documentation support - customer documentation
• Populate customer quality system documents
• Editorial support for customer documents and templates
• IQ/OQ/PQ templates
• Complete IQ template developed for DC100 platform
• Develop / populate customer templates
• Assist with and/or execute IQ protocols
• Assist with and/or execute OQ protocols
• Assist with PQ process