DATA INTEGRITY | REGULATORY READY
DI and Regulatory Compliances
Services
Assessment, Remediation, and control of Data Integrity risks to ensure compliance with ALCOA+ principles, FDA 21 CFR Part 11, EU Annex 11, and Global Regulatory expectations.
Our DI and Regulatory Compliances Services
Data Integrity Risk Assessment
Identification and evaluation of data integrity risks across systems, processes, and records in accordance with ALCOA+ principles.
Key Deliverables
- Data Integrity Risk Assessment Report
- System & Process Risk Mapping
- Critical Data Flow Identification
ALCOA+ Compliance Implementation
Implementation of procedural and technical controls to ensure data is attributable, legible, contemporaneous, original, accurate, and complete.
Key Deliverables
- ALCOA+ Gap Assessment
- Data Integrity Control Matrix
- Updated SOPs & Work Instructions
21 CFR Part 11 & EU Annex 11 Compliance
Assessment and remediation of electronic records and electronic signature controls to meet global regulatory requirements.
Key Deliverables
- Part 11 / Annex 11 Gap Analysis
- Electronic Records & Signature Assessment
- Compliance Remediation Plan
Audit Trail & Access Control Review
Review of audit trails, user access, and system security to ensure traceability and prevent unauthorized data changes.
Key Deliverables
- Audit Trail Review Report
- User Access & Privilege Matrix
- Security & Traceability Findings
Data Integrity Remediation & CAPA
Risk-based remediation of identified data integrity deficiencies supported by root cause analysis and CAPA implementation.
Key Deliverables
- Root Cause Analysis (RCA)
- Data Integrity CAPA Plan
- Remediation Effectiveness Evidence
Ongoing Data Governance & Monitoring
Establishment of governance, periodic review, and monitoring mechanisms to sustain data integrity compliance.
Key Deliverables
- Data Governance Framework
- Periodic Review & Monitoring Plan
- Continued Compliance Evidence
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 data integrity in regulated industries?
Data integrity refers to the completeness, consistency, and accuracy of data throughout its lifecycle. In regulated industries, data integrity ensures that records are attributable, legible, contemporaneous, original, accurate, and complete (ALCOA+), as required by FDA, EMA, and MHRA regulations.
What are ALCOA+ principles and why are they important?
ALCOA+ principles define regulatory expectations for trustworthy data. They ensure that data is properly attributed, recorded at the time of activity, protected from unauthorized changes, and retained in a complete and accurate form. Compliance with ALCOA+ is a key focus area during regulatory inspections and data integrity audits.
How do you assess data integrity compliance during audits?
We perform risk-based data integrity assessments that include process reviews, system configuration checks, audit trail evaluation, user access analysis, and data flow mapping. Identified gaps are documented and prioritized based on regulatory risk and data criticality.
What is the role of 21 CFR Part 11 and EU Annex 11 in data integrity?
FDA 21 CFR Part 11 and EU Annex 11 define requirements for electronic records and electronic signatures. These regulations ensure data security, audit trails, access control, and record authenticity, forming a critical part of data integrity compliance in computerized systems.
How do you remediate data integrity gaps identified during inspections?
Data integrity gaps are remediated through root cause analysis (RCA), risk-based corrective and preventive actions (CAPA), system control enhancements, and procedural updates. Remediation activities are documented to provide clear, defensible evidence during regulatory inspections.