Prepare Before the Inspection
Identify evidence gaps, prepare SMEs, test inspection-response workflows and prioritize the issues most likely to influence regulatory outcomes.
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Inspection Preparation and Independent Assurance
Inspection & Audit
Independent, risk-based audit and inspection support for regulated life sciences organizations requiring stronger compliance visibility, credible assurance, inspection readiness and practical remediation priorities.
Service Overview
Independent Insight Across Complex GxP Environments
The Inspection & Audit portfolio is designed to support organizations before, during and after high-stakes regulatory or client scrutiny, with clear findings and practical next steps.
Assess Real Process Control
Evaluate how procedures, responsibilities, oversight and quality systems operate in practice, not only how they are described in documentation.
Turn Findings Into Priorities
Translate observations into risk-ranked actions that support remediation, leadership decisions and sustainable quality improvement.
Specialized Services
Inspection and Audit Services
Select a service to explore the engagement scope, deliverables, business value and support available for your organization.
Regulatory Preparation
Inspection Readiness
Structured preparation for regulatory, sponsor and client inspections, including readiness assessments, mock inspections, evidence review, SME preparation and inspection-response planning.
- Readiness and gap assessments
- Mock inspection simulations
- SME and leadership preparation
- Document request and war-room planning
GCP Audits
Independent clinical quality audits covering participant protection, protocol compliance, sponsor oversight, CRO performance, trial documentation and data reliability.
- Investigator site audits
- Sponsor and CRO audits
- Clinical process audits
- ICH GCP E6(R3)-aligned reviews
GLP Audits
Independent audits of nonclinical study conduct, raw data, laboratory processes, computerized systems, equipment controls and quality assurance oversight.
- Facility and study audits
- Raw data traceability review
- Equipment and system controls
- QA unit effectiveness assessment
GMP Audits
Risk-based audits of manufacturing, laboratory, documentation, supplier and quality system controls supporting product quality and regulatory compliance.
- Manufacturing and facility audits
- Batch record and documentation review
- Deviation, CAPA and change-control assessment
- Contract manufacturer and supplier audits
GVP Audits
Independent assessment of pharmacovigilance systems, safety case management, signal processes, partner oversight and compliance with safety reporting responsibilities.
- Pharmacovigilance system audits
- Case processing and reporting review
- Signal management assessment
- Partner and vendor oversight audits
Vendor & Service Provider Audits
Qualification and oversight audits for CROs, laboratories, technology providers, manufacturers, consultants and other critical suppliers supporting regulated activities.
- Prequalification and requalification audits
- Risk-based vendor assessment
- Quality agreement and oversight review
- Performance and CAPA follow-up
TMF Audits
Independent review of Trial Master File completeness, quality, timeliness, traceability and inspection readiness across paper, electronic and hybrid environments.
- TMF completeness and quality review
- Essential document assessment
- Filing timeliness and process control
- eTMF governance and oversight
Data Integrity & Computerized Systems Audits
Evaluation of ALCOA+ practices, audit trails, access controls, electronic records, computerized system governance and data lifecycle controls.
- Paper and electronic data integrity
- Audit trail and access-control review
- Computerized system lifecycle assessment
- CSV and governance considerations
For-Cause & Focused Audits
Targeted investigations and focused compliance reviews when serious concerns, repeat findings, deviations or potential systemic failures require independent evaluation.
- Investigation-driven audits
- Repeat finding and recurrence reviews
- Focused process and system audits
- Urgent independent compliance assessment
Audit Program Development
Design and optimization of risk-based internal and external audit programs aligned with organizational priorities, regulatory exposure and vendor risk.
- Risk-based audit strategy
- Audit universe and annual planning
- Vendor audit prioritization
- Auditor qualification and governance
Business Value
Independent Assurance That Supports Better Decisions
Audit findings are most valuable when they improve visibility, strengthen leadership decisions and help the organization focus resources on the risks with the highest regulatory and operational impact.
Earlier Risk Detection
Identify weaknesses in records, systems, governance and oversight before they become regulatory observations or repeat findings.
Stronger Inspection Confidence
Prepare teams, evidence and leadership to demonstrate that regulated processes are understood, controlled and supported by reliable data.
More Focused Remediation
Prioritize systemic and high-risk issues so corrective actions target the real causes of compliance exposure.
Engagement Process
A Clear Path From Scope Definition to Actionable Findings
Engagements can be adapted for planned audit programs, urgent inspection preparation, focused risk reviews or independent investigation support.
Discovery and Context
Understand the organization, regulated activity, business objective, known quality risks and inspection or audit exposure.
Scope and Planning
Define audit criteria, sites, functions, systems, vendors, stakeholders, timing and expected deliverables.
Assessment and Evidence Review
Conduct interviews, walkthroughs, document review, record sampling and evaluation of operational and quality controls.
Reporting and Priorities
Deliver clear findings, risk classification, executive insight and practical recommendations for remediation.
When This Category Is Most Valuable
Common Inspection and Audit Scenarios
Independent audit support can be used proactively, as part of routine governance, or urgently when significant compliance risk becomes visible.
Upcoming Regulatory Inspection
An authority inspection has been announced and rapid readiness assessment is required.
Vendor Qualification
A critical supplier or service provider must be assessed before engagement or renewal.
Repeat Findings
Similar deviations, CAPAs or audit observations indicate a possible systemic weakness.
Growth or Change
New teams, sites, systems or vendors have increased quality and oversight complexity.
Data Integrity Concerns
Electronic records, audit trails, raw data or documentation practices require independent review.
Transaction Due Diligence
A partner, acquisition target or investment requires quality and compliance assurance.
Program Maturity Review
Leadership needs an independent view of audit strategy, quality maturity and risk coverage.
Urgent Compliance Concern
A serious event requires focused, confidential and independent assessment.