Equipment, Facilities, Utilities Qualification
Our Approach to Equipment, Facilities, and Utilities (EFU) Qualification
We partner with you to optimize qualification efforts, reducing costs while focusing resources on the most business-critical systems. Using a risk-based approach (RBA) aligned with FDA expectations and ISPE Baseline Guide 8, we prioritize qualification activities that directly impact product quality and patient safety—improving efficiency and saving both time and money.
We can provide support for part or for all of your EFU qualification needs.
MAPTech can support all or part of your EFU qualification program, offering supplemental subject matter expertise or leading the project end-to-end. Our consultants ensure that each stage—from User Requirement Specifications (URS) through Design Qualification (DQ)—is properly documented and fully compliant. We also create comprehensive traceability matrices to satisfy FDA and other regulatory requirements.
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Typical documentation deliverables include:
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Design Qualification (DQ)
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Installation Qualification (IQ)
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Operational Qualification (OQ)
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Performance Qualification (PQ)
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Change Management Plans
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Decommissioning Plans