TESTING OVERSIGHT & ANALYTICAL REVIEW
Ensure Accurate, Defensible, Inspection-Ready Analytical Results
Independent, audit-trained review of the test data and documentation produced by your third-party contract laboratory — verified against regulatory requirements before it supports a release decision or a submission.
Analytical data is the evidence base for every release decision, every shelf-life claim, and every regulatory submission your organization makes. When that data is generated by an external laboratory — and reviewed only by the people who generated it — you are carrying risk you cannot see.
ARIREX reviews the data package the third-party laboratory issues to you — method validation records, test results, investigation reports, and supporting documentation — the way a regulator would: against the applicable requirement, on the strength of objective evidence. We do not manage or direct the laboratory's operations; we independently assess what it produces. Regulatory responsibility for outsourced testing does not transfer to the laboratory performing it — it stays with you. Our role is to make sure the data you are relying on can carry that weight.
How the Process Works
ARIREX has no direct relationship with the third-party laboratory and does not manage its day-to-day operations. Our review begins once the laboratory has completed its work and issued its data to you:
Samples are sent to the laboratory
Either you send samples directly to the third-party laboratory of your choice, or ARIREX arranges sample submission on your behalf — whichever is set out in our engagement agreement.
The laboratory performs the testing
The laboratory conducts the analysis and issues its data, certificate of analysis, method validation package, or investigation report to you.
You forward the data package to ARIREX
As soft copies (electronic files) or hard copies (physical documents) — whichever suits your systems and confidentiality requirements.
ARIREX independently reviews the data
We assess it against the applicable regulatory requirement — method validation adequacy, specification compliance, audit trail integrity, or investigation rigour, depending on scope.
ARIREX delivers a written report
A risk-ranked assessment with findings traceable to objective evidence and cited to the applicable regulation, guideline, or standard.
You use the report
To support your release decision, strengthen a CAPA response, or defend a regulatory submission.
Whichever arrangement applies, ARIREX has no ongoing operational or commercial relationship with the laboratory itself — our review is based on the data it produces, which is what keeps the assessment genuinely independent.
When Test Data Doesn't Hold Up
Laboratory controls and data integrity remain among the most frequently scrutinized areas in regulatory inspections across the pharmaceutical sector. The consequences of weak testing data are rarely confined to the laboratory:
A submission is delayed because method validation data does not support the specification that was filed.
A batch is held while an out-of-specification investigation is reopened for insufficient root cause justification.
A contract laboratory's finding becomes your finding — regulatory accountability for outsourced testing stays with the product owner.
An audit trail gap surfaces during inspection, and every result generated on that system comes into question.
A stability programme cannot defend the shelf life already printed on the label.
A supplier qualification is challenged because the laboratory that tested your incoming material was never independently assessed.
Every one of these is recoverable. All of them are cheaper to prevent than to remediate.
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 Data Review
Independent review of the test data, certificates of analysis, and reporting the third-party contract laboratory issues to you — confirming that methods, specifications, and results meet US FDA, Health Canada, and EU GMP expectations, based on the records and data provided.
Ideal for: manufacturers relying on external laboratories 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 and USP requirements — covering accuracy, precision, specificity, linearity, range, robustness, and the adequacy of the underlying raw data supporting each parameter.
Ideal for: organizations introducing a new test method, transferring a method between laboratories, or defending a method challenged during inspection.
3. Raw Material & Finished Product Testing Oversight
Review of testing programmes for raw materials, in-process samples, and finished products against compendial and registered specifications, including sampling plans, retest policies, and reduced-testing justifications.
Ideal for: manufacturers establishing or auditing their incoming and release testing programmes.
4. Stability Testing Programme Review
Review of stability study design, storage conditions, pull schedules, bracketing and matrixing justification, and data trending against ICH stability guidance and Health Canada / US FDA expectations.
Ideal for: organizations establishing shelf-life claims, extending expiry, or supporting a regulatory submission.
5. Microbiological Testing Oversight
Oversight of microbiological testing programmes, including environmental monitoring, bioburden, and sterility testing, against USP General Chapters and GMP expectations — with attention to method suitability, alert and action limits, and excursion investigation.
Ideal for: manufacturers of sterile products or facilities operating active environmental monitoring programmes.
6. Data Integrity & Laboratory Data Review
Review of laboratory data governance against ALCOA+ principles and 21 CFR Part 11 — covering audit trail review practices, chromatography data system (CDS) configuration, user access and privilege control, sample sequence and reprocessing controls, and electronic record lifecycle management.
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 and OOT investigations for scientific rigour, adequacy of root cause determination, justification of invalidated results, 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 and calibration, reference standard management, personnel training and competency, document control, and change management.
Ideal for: contract laboratories and in-house QC laboratories maintaining or pursuing accreditation, or preparing for client audits.
What You Receive
Every ARIREX engagement concludes with a documented, evidence-based deliverable package:
Data Review Report
Written findings supported by objective evidence: documents reviewed, data examined, systems assessed, personnel interviewed. Every observation is traceable to a specific requirement.
Risk-Ranked Observation Log
Findings classified by regulatory and product-quality impact, so your team knows what to address first.
Regulatory Traceability
Each observation cited to the applicable regulation, guideline, compendial chapter, or ISO clause.
Practical Remediation Guidance
Recommended corrective actions written by people who have implemented them, not generic instructions to revise an SOP.
Executive Summary
Issued when the review identifies a significant finding — such as a deviation, an OOS/OOT investigation adequacy issue, or a data integrity concern — that warrants senior management, quality council, or board-level attention. Not issued for routine reviews with no such finding.
Who We Work With
Pharmaceutical and biologics manufacturers relying on contract laboratories for raw material, in-process, release, or stability testing.
Virtual and emerging pharma companies without internal QC infrastructure, who need qualified oversight of every outsourced analytical activity.
Contract laboratories and CROs seeking independent readiness assessment ahead of a client audit or regulatory inspection.
Medical device and IVD manufacturers whose test method validation and data controls fall under quality system scrutiny.
Natural health product, cosmetics, and food manufacturers meeting Health Canada, US FDA, or ISO testing and specification requirements.
Organizations under regulatory pressure — responding to a Form 483 observation, warning letter, import alert, or a data integrity commitment already made to an agency.
Why Companies Choose ARIREX
Dedicated, Industry-Experienced Reviewers
Our reviewers are dedicated, industry-experienced professionals with real, hands-on laboratory and quality assurance backgrounds — not desk-based generalists. They have managed testing operations, signed off on batch release decisions, and defended their own data in front of regulators, before ever reviewing someone else's.
Practitioner-Led Review
Because our team has direct laboratory management and quality assurance experience, we assess method validation, investigation quality, and data governance with the judgement of people who have owned those decisions.
Genuinely Independent
ARIREX holds no commercial interest in the laboratories we assess and accepts no referral arrangements from them. Our finding is our finding.
Objective Evidence, Always
No finding is written on assumption or impression. Every observation in an ARIREX report is anchored to a document, a record, a data set, or a witnessed activity — the same standard a regulator applies.
Built for Defensibility
Our reports are structured to survive a real inspection, not to satisfy an internal checklist. If a finding cannot be supported with evidence, it does not go in the report.
A Global Auditor Network
ARIREX works with expert, dedicated, and experienced auditors across North America, Europe, and Asia — allowing us to assess laboratories where they operate and deliver consistent standards across a multi-site supply chain.
Confidentiality by Default
All engagements operate under a signed confidentiality agreement. Your data, findings, and remediation status remain yours. We do not name clients in marketing materials without written permission.
Standards and Frameworks We Assess Against
Analytical method validation and verification
ICH guidance on validation of analytical procedures and analytical procedure development; USP General Chapters <1225> and <1226>.
Stability
ICH stability testing guidance for new drug substances and drug products.
Laboratory data integrity
ALCOA+ principles; 21 CFR Part 11; MHRA data integrity guidance; PIC/S good practice guidance on data management and integrity; WHO data integrity guidance.
GMP laboratory controls
US 21 CFR Part 211 Subpart I; EU GMP Part I Chapter 6; Health Canada Good Manufacturing Practices Guide (GUI-0001).
Microbiological and sterile testing
USP General Chapters <61>, <62>, and <71>; EU GMP Annex 1.
Laboratory competence
ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories. ARIREX assesses laboratory quality systems against this standard.
Our Testing Oversight Process
Scope
We define which testing programmes, methods, data sets, or laboratories require review, and agree the standards each will be assessed against. A confidentiality agreement is executed before any document exchange.
Review
Assessment of the data package the third-party laboratory has issued to you — document and data-level review, including raw data examination and audit trail review, as scope requires.
The review can be conducted remotely with you, or you can send the data package directly to ARIREX for assessment — as soft copies (electronic files) or hard copies (physical documents), whichever best suits your systems and confidentiality requirements.
Report
Findings delivered with clear, risk-ranked observations, each traceable to objective evidence and cited to the applicable requirement.
Remediate
Support for corrective and preventive action development, review of your CAPA responses for adequacy, and re-review of remediated areas.
Sustain
Ongoing oversight as methods change, laboratories change, and regulations change — supporting continued vendor qualification and periodic review requirements.
How Engagements Are Structured
Targeted Review
A single method validation package, one stability study, or one OOS investigation. Fast, defined scope, fixed fee. A common entry point for new clients.
Laboratory Assessment
A full on-site or remote assessment of a contract or in-house laboratory against GMP laboratory controls and ISO/IEC 17025, with a formal report.
Data Integrity Assessment
A focused review of laboratory data governance — audit trails, CDS configuration, access control, and electronic record lifecycle — against ALCOA+ and 21 CFR Part 11.
Ongoing Oversight Programme
Scheduled periodic review of your network of third-party contract laboratories, supporting continuous vendor qualification and annual product quality review requirements.
Remediation Support
Post-finding support where a regulatory observation or client audit has already identified a laboratory or data integrity gap.
Frequently Asked Questions
Find Out Where Your Testing Data Is Exposed
Book a complimentary 30-minute consultation. We will discuss your current testing arrangements, identify where independent oversight adds the most value, and outline a scope — with no obligation to proceed.