Validation Support Services

Oakriver Technology Validation Services

GHTF

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