Validation Services
FDA 21 CFR Part 11 compliant IQ/OQ/PQ validation services for environmental monitoring systems. GAMP 5 methodology with complete documentation packages.
IQ/OQ/PQ Methodology
Comprehensive qualification for regulatory compliance
Installation Qualification
Verify that equipment is installed correctly according to specifications and manufacturer guidelines.
- Installation checklist
- Hardware verification
- Documentation review
Operational Qualification
Confirm that equipment operates as intended across the entire operating range.
- Functional testing
- Alarm testing
- Performance verification
Performance Qualification
Demonstrate that the system performs as expected under real-world conditions.
- System integration testing
- Report generation
- Compliance verification
Regulatory Compliance
ATEK validation services are designed to meet the requirements of FDA, EMA, and other regulatory authorities. Our validation approach follows GAMP 5 guidelines and is tailored to your specific compliance needs.
- FDA 21 CFR Part 11 compliance
- GAMP 5 methodology
- cGMP requirements
- EU GMP Annex 11
- ISO 13485 support
- Complete documentation package
Validation Deliverables
- Validation Master Plan (VMP)
- User Requirements Specification (URS)
- Functional Requirements Specification (FRS)
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Validation Summary Report
- Traceability Matrix
Our Validation Process
Structured approach to system qualification
Planning
Define scope, develop Validation Master Plan, and establish requirements.
Protocol Development
Create IQ/OQ/PQ protocols and test scripts based on requirements.
Execution
Execute test protocols, document results, and manage deviations.
Documentation
Compile validation summary report and obtain final approvals.
Frequently Asked Questions
What validation documentation does ATEK provide?
ATEK provides complete validation documentation including Validation Master Plan, User Requirements Specification, Functional Requirements Specification, IQ/OQ/PQ protocols, test scripts, and validation summary reports.
Does ATEK follow GAMP 5 guidelines?
Yes, all ATEK validation services follow GAMP 5 guidelines. Our validation approach is risk-based and scalable to meet the specific requirements of your system and regulatory environment.
How long does system validation take?
Validation timeline depends on system complexity and scope. A typical environmental monitoring system validation takes 2-4 weeks. ATEK works with you to develop a timeline that meets your project requirements.
Can ATEK help with FDA audit preparation?
Yes, ATEK provides ongoing validation support and can assist with FDA audit preparation. Our documentation is designed to withstand regulatory scrutiny and demonstrate compliance.
Need Validation Services?
Contact us to discuss your validation requirements and receive a customized proposal.