Validation Services
Built upon OakRiver's quality system, our Validation Support Services were designed to assist our health and medical device customers with scaling up a validated manufacturing operation. Our customers save time and money through a validation plan delivered in conjunction with the automation equipment.
If OakRiver has designed and built a piece of equipment, we are naturally suited to offer additional "down-stream" services such as validation support given our in-depth understanding of a piece of equipment and Title 21 CFR part 11 compliance.
Validation support services include;
If OakRiver has designed and built a piece of equipment, we are naturally suited to offer additional "down-stream" services such as validation support given our in-depth understanding of a piece of equipment 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
- Develop user manuals & standard work procedures
Contact us Today
Phone: 651.770.8710
Fax: 651.770.8724
www.OakRiver.biz
Phone: 651.770.8710
Fax: 651.770.8724
www.OakRiver.biz