AUDIT READINESS & REMEDIATION SERVICES
AUDIT AND REMEDIATION
SERVICE
We help organizations prepare for regulatory inspections, support live audits, and remediate compliance gaps through a structured, risk-based approach aligned with FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
Our Audit & Remediation Services
Inspection Readiness & Mock Audits
Proactive evaluation of inspection readiness to identify compliance gaps prior to regulatory inspections.
Key Deliverables
- Inspection Readiness Assessment
- Mock Inspection Findings Report
- Compliance Gap Assessment
Regulatory Inspection Support (Front & Back Room)
On-site and remote support during FDA, EMA, or notified body inspections.
Key Deliverables
- Controlled Document Retrieval
- Real-Time Inspection Response Support
- Validation Evidence Compilation
Inspection Observation Management
Structured handling of regulatory observations to ensure accurate, timely, and defensible responses.
Key Deliverables
- Observation Impact Assessment
- Root Cause Analysis (RCA)
- CAPA Definition & Documentation
CSV Remediation & Retrospective Validation
Remediation of identified CSV deficiencies in operational and legacy computerized systems.
Key Deliverables
- Retrospective Validation Strategy
- Remediated CSV Documentation
- Risk-Based Revalidation Plan
Data Integrity Remediation (ALCOA+)
Assessment and remediation of data integrity vulnerabilities in line with ALCOA+ principles.
Key Deliverables
- Data Integrity Risk Assessment
- ALCOA+ Gap Remediation Plan
- Data Governance & Control Enhancements
Post-Inspection Compliance Sustainability
Implementation of corrective and preventive controls to ensure sustained regulatory compliance.
Key Deliverables
- SOP & Governance Enhancements
- Periodic Review & Monitoring Framework
- Ongoing Compliance Improvement Plan
SERVICE HIGHLIGHT
Mock Inspections &
Audit Support
Don’t wait for the regulator to find a gap. Our “Front-Room/ Back-Room” audit support services prepare your team for the pressure of a live FDA or EMA inspection.
100%
Audit Success Rate
90+
Systems Validated
What's included in Audit Support:
- Personnel Coaching & Roleplay
- Document Room Management
- Rapid Response Validation Evidence
- Post-Audit Remediation Planning
- Observation (Form 483) Defense
FAQs
Addressing the complex concerns of quality and IT leadership.
What is audit readiness in computerized system validation (CSV)?
Audit readiness in CSV refers to the state where computerized systems, validation documentation, and data integrity controls are fully compliant and can be confidently presented during FDA, EMA, or notified body inspections. This includes up-to-date validation records, traceability, risk assessments, and Part 11 / Annex 11 compliance evidence.
How do you support organizations during FDA or EMA inspections?
We provide real-time front-room and back-room inspection support, including document retrieval, validation evidence presentation, clarification of CSV controls, and assistance in responding to inspector questions. Our support helps ensure accurate, consistent, and defensible responses during regulatory inspections.
How do you handle regulatory observations such as FDA Form 483 findings?
We assess the impact of each observation, perform root cause analysis (RCA), and develop risk-based corrective and preventive actions (CAPA). Our approach ensures responses are scientifically justified, regulator-aligned, and supported by appropriate validation and data integrity evidence.
What is retrospective validation and when is it required?
Retrospective validation is performed for existing or legacy computerized systems that were implemented without adequate validation. It involves reconstructing validation documentation, assessing system risks, and implementing remediation actions to meet current regulatory expectations without unnecessary system disruption.
How do you ensure data integrity compliance during audits?
We assess data integrity risks using ALCOA+ principles, focusing on data accuracy, traceability, access controls, audit trails, and system governance. Where gaps are identified, we implement remediation measures and controls to ensure sustained data integrity and inspection readiness.