Evaluate Study Conduct
Assess protocol adherence, study execution, observations, raw data, specimen handling and reporting to determine whether study evidence is complete and reliable.
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Good Laboratory Practice Auditing
GLP Audits
Independent, risk-based GLP audits for nonclinical laboratories, contract research organizations, test facilities and regulated research environments seeking stronger study integrity, reliable raw data, effective quality assurance and inspection-ready operations.
Service Overview
Independent Assurance Across the Nonclinical Study Lifecycle
GLP audits evaluate whether studies are planned, conducted, monitored, recorded, reported and archived in a controlled manner that supports scientific integrity, regulatory confidence and reliable reconstruction.
Assess Laboratory Systems
Review facilities, equipment, computerized systems, methods, environmental conditions and operational controls supporting regulated nonclinical work.
Challenge QA Effectiveness
Evaluate the independence, planning, execution, reporting and follow-up activities of the quality assurance unit.
Common GLP Risks
Where Laboratory and Study Controls Commonly Break Down
GLP risk often emerges where raw data cannot be reconstructed, responsibilities are unclear, equipment control is weak or quality assurance activities do not identify systemic issues.
Incomplete Raw Data Traceability
Observations, calculations, corrections, metadata or source records do not provide a complete and attributable reconstruction of study work.
Protocol and SOP Noncompliance
Study activities, methods or laboratory processes are not performed consistently with approved protocols and controlled procedures.
Weak Equipment and System Control
Qualification, calibration, maintenance, access control or audit trail practices do not adequately support data reliability.
Ineffective QA Oversight
QA inspections, findings, escalation or follow-up activities do not provide sufficient independent assurance over study and facility risk.
GLP Audit Types
Flexible Audit Scope Based on Study and Facility Risk
Audit scope can focus on a single study, facility, method, system or process, or support a wider GLP compliance and inspection-readiness program.
Facility Audits
Independent review of the overall GLP framework, organizational controls, facilities, equipment, systems, documentation and QA oversight.
- Organization and personnel responsibilities
- Facility design and environmental control
- Equipment qualification and maintenance
- SOP and document control systems
- Archive and record-retention controls
Study Audits
Assessment of study execution from protocol approval through raw data, observations, analysis, reporting and archival.
- Protocol and amendment control
- Study director oversight
- Test and reference item control
- Raw data and specimen traceability
- Final report consistency
Process Audits
Focused review of high-risk laboratory and study-support processes where control weaknesses may affect study reliability.
- Sample and specimen management
- Method validation and execution
- Data review and approval
- Equipment and calibration processes
- Deviation and CAPA management
Computerized Systems Audits
Evaluation of electronic records, system lifecycle controls, access, audit trails and data integrity risks within GLP operations.
- System validation and lifecycle governance
- User access and privilege control
- Audit trail generation and review
- Backup, retention and recovery
- Electronic record integrity
Quality Assurance Unit Audits
Independent assessment of QA independence, inspection planning, reporting, escalation and follow-up effectiveness.
- QA organization and independence
- Inspection program and coverage
- Finding classification and reporting
- Management notification
- CAPA and follow-up oversight
For-Cause GLP Audits
Focused independent review when data reliability, repeat deviations, study conduct or potential systemic failures require urgent assessment.
- Data integrity concerns
- Protocol or SOP noncompliance
- Repeat findings or recurring deviations
- Equipment or system failure impact
- Independent investigation support
Audit Scope
Areas Commonly Evaluated During a GLP Audit
The final audit scope is adapted to the study type, facility, computerized environment, known risks and intended regulatory or business outcome.
Organization and Personnel
- Defined roles and responsibilities
- Study director authority
- Training and qualification
- Workload and resource adequacy
- Delegation and oversight
Protocol and Study Control
- Protocol approval and amendments
- Study plan adherence
- Deviation documentation
- Study communication and escalation
- Final report accuracy
Raw Data and Records
- Contemporaneous recording
- Attribution and traceability
- Corrections and amendments
- Data review and approval
- Archive and retrieval
Equipment and Facilities
- Qualification and calibration
- Preventive maintenance
- Environmental monitoring
- Equipment status control
- Facility segregation and suitability
Test and Reference Items
- Receipt and identification
- Characterization and stability
- Storage conditions
- Preparation and use
- Reconciliation and disposition
Quality Assurance
- QA inspection planning
- Study, facility and process coverage
- Reporting to management
- Finding follow-up
- Statement of QA activities
Audit Process
A Structured GLP Audit From Planning to Follow-Up
The process is designed to produce objective findings, clear risk classification and practical recommendations for laboratory, QA and leadership teams.
Context and Scope Review
Understand the facility, study type, systems, previous findings, inspection exposure and business purpose of the audit.
Risk-Based Planning
Define audit criteria, documentation needs, sampling strategy, interviewees and high-risk areas requiring deeper review.
Pre-Audit Document Review
Review protocols, SOPs, study records, QA documentation, equipment records, validation files and available quality data.
Audit Execution
Conduct interviews, laboratory walkthroughs, study reconstruction, document review, raw data sampling and system demonstrations.
Finding Evaluation
Assess significance, recurrence, systemic impact and potential effect on study integrity or regulatory confidence.
Reporting and Follow-Up
Deliver risk-ranked findings, recommendations and optional CAPA review or effectiveness verification support.
Deliverables
Clear Outputs for Laboratory, QA and Leadership Teams
Deliverables can be adapted to qualification, routine compliance, inspection readiness, due diligence or for-cause audit objectives.
Audit Plan
- Audit objectives and scope
- Applicable GLP criteria
- Functions and systems included
- Document request list
- Audit schedule and interview plan
Audit Report
- Executive summary
- Evidence-based observations
- Risk classification
- Systemic and recurring themes
- Recommended next steps
Leadership Risk Summary
- Material compliance concerns
- Study integrity implications
- Data reliability concerns
- Inspection exposure
- Priority decisions and actions
CAPA Review Support
- Root cause challenge
- Action adequacy review
- Risk reduction assessment
- Evidence expectations
- Closure-readiness considerations
Follow-Up Audit
- CAPA implementation review
- Evidence verification
- Repeat finding assessment
- Residual risk review
- Effectiveness verification
Inspection Readiness Summary
- Critical readiness gaps
- Priority study and facility risks
- QA and leadership actions
- Document readiness considerations
- Final readiness priorities
When GLP Audits Are Most Valuable
Common Laboratory and Study Audit Scenarios
GLP audits can support qualification, routine assurance, inspection preparation, transaction due diligence or urgent independent review.
Test Facility Qualification
A laboratory or CRO requires independent assessment before study award or contract renewal.
Upcoming GLP Inspection
The organization needs assurance over study, facility, QA and data readiness before regulatory scrutiny.
Study Integrity Concern
Raw data, protocol compliance or study reconstruction requires focused independent review.
Repeat Deviations
Similar findings or deviations indicate a possible systemic laboratory or quality-system weakness.
Computerized System Risk
Electronic records, audit trails or system lifecycle controls require independent assessment.
QA Program Maturity Review
Leadership needs an independent view of QA coverage, independence and inspection effectiveness.
Transaction Due Diligence
A laboratory, research platform or acquisition target requires GLP compliance and quality-risk assessment.
For-Cause Investigation
Serious study or data concerns require confidential and targeted independent assurance.
Business Value
Protect Study Integrity and Regulatory Confidence
Independent GLP audits help organizations identify weaknesses earlier, strengthen laboratory governance and improve confidence in study data, facility control and quality assurance.
More Reliable Study Evidence
Improve confidence that raw data, observations, calculations and final reports are complete, traceable and reconstructable.
Stronger Facility Control
Identify weaknesses in equipment, systems, methods, environmental conditions and operational governance.
More Effective QA Oversight
Strengthen QA independence, inspection coverage, escalation and follow-up across studies and laboratory processes.
FAQ
GLP Audit Questions
Common questions from laboratories, CROs, sponsors and research organizations considering independent GLP audit support.
Can GLP audits be conducted remotely?
Yes. Depending on the scope, document availability and system access, selected facility, study, process and computerized system audits can be delivered remotely or through a hybrid model.
Can the audit focus on one specific study?
Yes. A study audit can focus on protocol compliance, raw data, specimen control, equipment, computerized systems, reporting and study reconstruction.
Can you audit a contract laboratory or CRO?
Yes. Qualification, requalification and oversight audits can be performed for contract research organizations, laboratories and other regulated service providers.
Can you assess computerized systems used in GLP work?
Yes. Scope can include system lifecycle governance, validation, access control, audit trails, electronic records, backup, retention and data integrity.
Can you support CAPA development after the audit?
Yes. Support can include root cause review, CAPA adequacy assessment, remediation planning and follow-up effectiveness verification.
Is the engagement confidential?
Yes. GLP audit engagements are handled confidentially, and NDA-based collaboration can be used where required.