Both regulations, 21 CFR Part 210 and 211, specify that Equipment, Facilities and Utilities (EFU) require qualification when they have direct product impact. EFU qualification is also just good practice. Qualification testing provides you with the assurance that your equipment is operating properly and that it meets both user and product-requirement specifications.
Our Approach to Equipment, Facilities and Utilities Validation
We work with you to reduce qualification costs while focusing efforts on the most business-critical elements. We use a risk-based approach (RBA) that is inline with industry standards (FDA, ISPE Baseline Guide 8). We focus qualification efforts on those areas that have the greatest impact to your product/process, which increases efficiency and helps you save time and money.
Our Equipment, Facilities & Utilities professionals have over 10 years of experience.
We can provide support for part or for all of your EFU qualification needs.
We can provide supplemental subject matter expertise or take the lead on the project. We can help you correctly document the User Requirement Specification (URS) through Design Qualification (DQ), and create the trace-ability matrix to meet the requirements of the FDA. Each EFU project involves documentation. Here is a list of some of the documents we typically produce:
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Change management plans
- Decommissioning plans