Inspection Readiness, Operationalized

A risk-based, regulatory-aligned service embedding continuous readiness into your clinical operations
Schedule a Consultation Independent Oversight
Why Inspection Readiness
Needs to Be Continuous
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Regulatory inspections are no longer rare or scheduled in advance. Authorities such as EMA, FDA, MHRA, and PMDA increasingly conduct unannounced and remote inspections, requiring sponsors and CROs to demonstrate real-time control over critical processes at any moment.

QARP’s IRaaS provides a structured, risk-based model that supports ongoing inspection readiness across people, systems, and data, aligned with current regulatory practices and expectations.

Measurable Outcomes:

  • Audit-Ready Systems
    Documentation, decisions, and controls aligned with regulatory expectations
  • Skilled, Ready Teams
    Demonstrated process knowledge and confident regulatory interactions
  • Reduced Inspection Risk
    Fewer and lower-severity findings; faster response and close-out
QARP IRaaS = system-level maturity + regulatory alignment + operational continuity

What We Deliver:

1. TMF / eTMF Technical Assessment


Deliverables:
  • Gap report with severity and regulatory impact
  • Remediation roadmap with actions, owners, and timelines
  • SOP templates and QC checklists for future-proofing
How we do it:
  • Metadata-driven analysis of completeness, control, and compliance.
  • Inventory Mapping
  • Artifact-level audit vs. TMF RM v3.x or your custom taxonomy
  • Identifies missing, misfiled, and obsolete records
  • Structure and Access Review
  • Checks folder logic, naming rules, ingestion flows, and RBAC
  • Timeliness and Governance
  • Compares planned vs. actual filing, monitors version lineage
  • Audit Trail Forensics
Assesses user actions, timestamps, e-signatures, and traceability
Benchmarked to 21 CFR Part 11, EU Annex 11, ALCOA+

2. Mock Inspections and Scenario Simulations

Deliverables:

  • Simulation report with graded findings (Critical/Major/Minor)
  • Full CAPA package with RCA tools and monitoring triggers
  • Option to conduct sessions with former FDA or EU inspectors to ensure regulatory realism and depth of assessment
How we do it:
  • Realistic, cross-functional inspection rehearsals tailored to authority procedures
  • Authority-Aligned Protocols
  • FDA BIMO, EMA/HMA, MHRA, PMDA, and local agency models
  • Role-Based Interviews
  • CRA, PI, DM, PV, Stats, QA, IT/CSV, vendor oversight
  • Evidence Tracing in Real Time
  • System/document walkthroughs, CAPA chain reviews
3. Functional Readiness Training
Deliverables, Materials & Formats

  • Quick-reference guides, readiness scripts, decision trees
  • Delivered via workshops, microlearning, and live drills
How we do it:
  • Targeted capability uplift for key inspection-facing roles
  • Protocol for Inspector Interactions
  • Structured Q/A strategies, bridging responses, and documentation access
  • Process Ownership Coaching
  • Articulation of controls, SOP design, performance indicators
  • Scenario-Based Learning
  • Interactive cases (e.g., ICF gaps, vendor oversight issues) with expert facilitation
Contact Our Team Let’s Discuss
How Engagement Works:
  • Diagnostic Phase
    Baseline maturity mapping and inspection readiness risk profiling
  • Implementation Phase
    Execution of remediation actions, training programs, and dashboard setup
  • Operational Phase
    Continuous monitoring, periodic mock drills, and quality cycle improvement
Built to Scale with You
QARP’s IRaaS integrates into your operations to support readiness at every stage from a single pivotal trial to a growing global portfolio.
Let’s align your processes with current expectations
Contact Us
Phone number: +34 625263964
Email: info@theqarp.com