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Validation Service Package from PeopleMed Includes:
Validation SOP
- Preparing the Validation Plan
- Performing Risk Assessment
- Addressing Change control
- Writing a Test Case Procedure
- Handling Validation Deviations
- Validating After a Change
Validation Plan
- Approach
- Resources
- Intended Use
- Risk Analysis
- Identify Critical Control Points
- Assess Degree of Testing Required
- Risk Mitigation Plan and Steps
- Schedule
- Activities
- Tasks
- Approvals
- Requirements
- Operation Qualification
- Performance Qualification
- Test Case Procedures
- Validation Report
SPECIALIZED SERVICES
Revalidation After:
- Hardware Change
- Software Upgrade
- Process Change
ISBT 128 Validation
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