Why choose AdvanceTechInfo?
A specialist validation partner — not a generalist IT vendor. Every engagement is scoped around the regulations your inspectors will cite.
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Expert Validation Team
Fully focused on CSV, GxP compliance and pharma regulations.
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Audit-Ready Documentation
Documentation and systems that pass inspections confidently.
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Customized Approach
Validation strategies tailored to each client's needs.
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End-to-End Compliance Support
From gap analysis to training, covering every stage.
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Trusted Partner
Working with companies who prioritize quality and patient safety.
A documented, repeatable sequence
- 01
GxP Assessment
Identify which systems require validation and categorize them per GAMP 5.
- 02
Validation Plan
A detailed validation plan for the system.
- 03
System Requirement Specifications (SRS)
Documented requirements for the system.
- 04
Risk Assessment
Initial and functional risk assessment.
- 05
Installation Qualification (IQ)
Verify hardware and software components are installed correctly.
- 06
Operational Qualification (OQ)
Verify all functions operate correctly.
- 07
Performance Qualification (PQ)
Verify system performance under real conditions.
- 08
Validation Summary Report (VSR)
Summary report issued after all qualification runs.
- 09
Traceability Matrix
Traces all tests across qualification activities.
- 10
System Release Certificate
Issued after all tests pass successfully.
Get a Free Consultation
Tell us about your systems. We will map them to GAMP 5 and outline the path to an audit-ready state — at no cost.