Multi-vendor System Life Cycle Validation

OneSource provides fully customized System Life Cycle Validation, GAMP 5 / ASTM E 2500/ USP 1058 AIQ compliant for laboratory instruments, including both software and hardware, and standardized protocols and procedures.

System Life Cycle Validation manages and integrates your instrument implementation projects from purchase to end-of-life, including software and hardware validation, SOP creation and method development and transfer validation. Some of the custom documents we can prepare include:

• User Functional Requirements Specifications (UFRS)
• Computer System Validation (CSV)
• Design Specifications / Qualification (DS/DQ)
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Administration / Operational / PM / Disaster Recovery / Backup & Restore SOP creation
• Risk Assessments
• 21CFR Part 11 Assessments
• Application development
• Training

How may I help you achieve your compliance goals?

Contact Joe Tehrani, global leader of OneSource Compliance and Laboratory Relocation services to learn more about how we can reduce the burden of compliance, control costs, improve productivity and ensure audit readiness in your labs.

Contact OneSource – Joe Tehrani
Joe Tehrani, Ph.D.
Global Business Leader
Qualification & Relocation Solutions
PerkinElmer OneSource Laboratory Services