ARIREX — Testing Services
Independent Oversight. Defensible Data.
ARIREX provides independent oversight of third-party analytical testing and laboratory operations — bringing an audit-trained eye to test data, method performance, and laboratory compliance. We help organizations verify that testing data will withstand regulatory scrutiny before it reaches a submission or a batch release decision.
Our Testing Oversight Practice Areas
ARIREX's testing practice covers eight core areas supporting laboratory quality, data integrity, and third-party test coordination across the product lifecycle.
1. Third-Party Analytical Testing Coordination
Coordination and oversight of testing performed by external contract laboratories, ensuring test methods, specifications, and reporting meet US FDA, Health Canada, and EU GMP expectations.
Ideal for: manufacturers relying on external labs for raw material, in-process, or finished product testing.
2. Analytical Method Validation & Verification Review
Independent review of method validation and verification packages against ICH Q2(R1) and USP General Chapter requirements, covering accuracy, precision, specificity, and robustness.
Ideal for: organizations introducing a new test method or transferring a method between laboratories.
3. Raw Material & Finished Product Testing Oversight
Review of testing programs for raw materials, in-process samples, and finished products against USP, Health Canada, and US FDA specifications.
Ideal for: manufacturers establishing or auditing their incoming and release testing programs.
4. Stability Testing Program Review
Review of stability study design, storage conditions, and data trending against ICH Q1A(R2) stability guidelines and Health Canada/US FDA expectations.
Ideal for: organizations establishing shelf-life claims or supporting a regulatory submission.
5. Microbiological Testing Oversight
Oversight of microbiological testing programs, including environmental monitoring and sterility/bioburden testing, against USP General Chapters and GMP expectations.
Ideal for: manufacturers of sterile products or facilities with active environmental monitoring programs.
6. Data Integrity & Laboratory Data Review
Review of laboratory data governance against ALCOA+ principles and 21 CFR Part 11, including audit trail review, chromatography data system (CDS) controls, and electronic record integrity.
Ideal for: organizations preparing for a data integrity-focused inspection or remediating a prior finding.
7. Out-of-Specification (OOS) & Out-of-Trend (OOT) Investigation Review
Independent review of OOS/OOT investigations for scientific rigor, root cause justification, and compliance with US FDA and Health Canada investigation expectations.
Ideal for: organizations strengthening their laboratory investigation process or responding to a regulatory finding.
8. Laboratory Quality System Audits
Audits of laboratory quality systems against ISO/IEC 17025 and GMP laboratory control requirements, covering equipment qualification, personnel training, and document control.
Ideal for: contract laboratories and in-house QC labs maintaining or pursuing accreditation.
Why ARIREX for Testing Oversight
Practitioner-led
Our reviewers have direct laboratory management and quality assurance experience, not just document-review backgrounds.
Built for defensibility
Every review is structured to withstand a real regulatory data integrity inspection, not just an internal checklist.
Independent perspective
As a third party, we identify gaps your internal team may be too close to see.
Our Testing Oversight Process
Scope
Defining which testing programs, methods, or data sets require review.
Review
Conducting document, data, and system-level assessment.
Report
Delivering findings with clear, risk-ranked observations.
Remediate
Supporting corrective action and re-review as needed.
Sustain
Ongoing oversight as methods, labs, or regulations change.
Ready to strengthen your testing data?
Book a free 30-minute consultation and we'll help you identify where independent testing oversight adds the most value.
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