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
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