DATA INTEGRITY: THE FOUNDATION OF PATIENT SAFETY
Data integrity is critical — without it patient safety is at risk. Traditional controls haven't been applied to electronic records and computer systems with the same rigour as paper-based processes. MAPTech Solutions bridges this gap, ensuring your digital records are trustworthy and compliant.
THE ALCOA++ STANDARD
- Attributable: Clear record of who performed an action.
- Legible: Readable throughout the record lifecycle.
- Contemporaneous: Documented at the time of the activity.
- Original: The first recording or a certified copy.
- Accurate: Verified, error-free, and truthful.
- Complete: All data, including repeats and reanalysis.
- Consistent: Follows chronological order and expected formatting.
- Enduring: Retained for the entire required period.
- Available: Accessible for review, audit, or inspection.
- Traceable (ALCOA++): Complete history of the data lifecycle per EU GMP.
ALCOA+ Data Integrity
The ALCOA+ framework defines the standards for data integrity in a regulated GxP environment. MAPTech Solutions provides guidance to ensure your systems remain compliant with FDA, EU, and global standards.
A
Attributable
Indicates who performed the action and when.
L
Legible
Data is readable and permanent throughout its lifecycle.
C
Contemporaneous
Data recorded at the time work is performed.
O
Original
First capture of the data or a certified true copy.
A
Accurate
Data is truthful, valid, reliable, and correct.
+
Complete & Traceable
Includes Consistent, Enduring, and EU GMP Traceability (ALCOA++).
Policies & Procedures
We develop cross-functional policies and lifecycle procedures that move beyond compliance-by-checklist to create a robust, resilient data integrity culture tailored to your specific operational environment.
Audit Trail Review
Risk-based procedures for periodic log assessment to identify and mitigate potential GxP data integrity issues.
Data Lifecycle Management
Managing records from creation and processing through to archiving and secure decommissioning.
DI Policy Development
Establishing the high-level framework for ALCOA+ compliance and data governance across the enterprise.
Incident Response
Workflows for handling data integrity failures, ensuring transparency and thorough root cause analysis.
System SOPs
Detailed technical instructions for managing computer systems, including access control, backup, and restoration.
DI Training Programs
Comprehensive staff training modules designed to foster a culture of quality and regulatory awareness.
DI GAP
ASSESSMENTS
Our expert team performs risk-ranked evaluations of your electronic data lifecycle. We move beyond simple check-boxes to analyze audit trails, access controls, and global regulatory alignment for FDA 21 CFR Part 11 and EU GMP Annex 11. We identify critical vulnerabilities across hybrid systems, laboratory instruments, and enterprise SaaS/cloud infrastructure.
THE DELIVERABLE
A prioritized, risk-ranked gap report accompanied by a comprehensive remediation roadmap, providing clear direction for inspection readiness and long-term compliance stability.
ASSESSMENT SCOPE
- Audit Trail Configuration
- Security & Access Control
- SaaS and Cloud Infrastructure
- Data Lifecycle Integrity
DATA INTEGRITY FRAMEWORK
Data Governance & Integrity Culture
Our data governance framework goes beyond technical controls, establishing a culture of ownership and accountability throughout the drug development lifecycle. We ensure your data remains attributable, legible, and contemporaneous by integrating integrity metrics into your daily operations.
Data Ownership
Establishing clear data stewardship roles across departments, ensuring accountability for data creation, modification, and long-term archiving.
DI Metrics & KPIs
Continuous monitoring of data integrity indicators through automated dashboards, providing visibility into compliance risks before findings occur.
Integrity Culture
Regular training and awareness to embed quality as an operational mindset, where data integrity is the baseline for every activity.
Periodic Reviews
Structured evaluation cycles for audit trails and electronic records, ensuring adherence to global ALCOA++ principles throughout the lifecycle.
Change Integration
Integrating DI requirements into the change control lifecycle, ensuring that updates never compromise the integrity of validated audit logs.