Inspection Readiness, Operationalized

A risk-based, regulatory-aligned service embedding continuous readiness into your clinical operations
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Independent Oversight
Why Inspection Readiness
Needs to Be Continuous
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Regulatory inspections are no longer rare or episodic. EMA, FDA, MHRA, and PMDA expect ongoing, demonstrable control over clinical processes, documentation, and decision-making.
QARP’s IRaaS delivers a structured, risk-based model to maintain this control in real time—across your people, systems, and data.

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
  • 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
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
Outputs

  • Simulation report with graded findings (Critical/Major/Minor)
  • Full CAPA package with RCA tools and monitoring triggers
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
Materials & Formats

  • Quick-reference guides, readiness scripts, decision trees
  • Delivered via workshops, microlearning, and live drills
Targeted capability uplift for key inspection-facing roles
Protocol for Inspector Interactions
Structured Q/A strategies, bridging responses, 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
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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