Data Integrity Consulting for Pharmaceutical & Life Sciences
Protect your organization with ALCOA+ compliant data practices. We help pharmaceutical, biotech, and medical device companies build data integrity into every system, process, and workflow across the UAE and GCC.
20+
Years Experience
100%
Audit Success
483
Remediation Expert
ALCOA+
Framework Aligned
Understanding ALCOA+ Data Integrity Framework
ALCOA+ is the FDA and international regulatory framework defining data integrity requirements for pharmaceutical and life sciences organizations.
ALCOA Principles
Attributable
Who acquired or performed the action? Data must be traceable to the individual who created or modified it.
Legible
Can the data be read and understood? Records must be clear, permanent, and interpretable throughout retention.
Contemporaneous
Was it recorded at the time of the activity? Data must be documented when the action occurred.
Original
Is it the first capture or a certified copy? Original records or verified true copies must be preserved.
Accurate
Does it correctly reflect the observation? Data must be error-free and truthfully represent the activity.
The "+" Extensions
Complete
All data including repeat tests, out-of-specification results, and failed runs must be recorded and retained.
Consistent
Data elements must match across all systems, with timestamps and sequences that make sense chronologically.
Enduring
Data must remain readable and accessible for the required retention period without degradation.
Available
Data must be retrievable for review, audit, or inspection throughout its retention lifecycle.
Our Data Integrity Services
Comprehensive support for building and maintaining data integrity across your regulated operations—from assessment to remediation to culture change.
ALCOA+ Assessments
Comprehensive evaluations of data practices against ALCOA+ principles across all systems, processes, and data types in your organization.
Data Governance Frameworks
Establish policies, procedures, roles, and controls for data integrity across your entire organization and system landscape.
System Configuration for Integrity
Configure systems to prevent data manipulation, ensure complete audit trails, and enforce proper access controls.
Audit Trail Design & Review
Design audit trail requirements, implement review procedures, and establish periodic audit trail assessment programs.
Remediation Programs
Address FDA 483s, warning letters, and inspection findings with prioritized remediation plans and execution support.
Staff Training & Culture Building
Build a data integrity culture through role-based training, awareness programs, and behavioral change initiatives.
Risk-Based Data Mapping
Identify critical data flows, assess vulnerability points, and implement controls based on impact to product quality and patient safety.
Access Control & Security
Design and implement role-based access controls, user authentication, and security procedures to protect data integrity.
Our Data Integrity Program Methodology
A systematic six-phase approach to building sustainable data integrity that goes beyond compliance checkboxes to genuine organizational culture.
Current State Assessment
We conduct a comprehensive data integrity assessment across your organization, evaluating systems, processes, documentation practices, and culture. This includes data flow mapping, audit trail review, access control analysis, and identification of vulnerability points.
Gap Analysis & Risk Prioritization
Identified gaps are categorized by severity and potential impact on data integrity, product quality, and patient safety. Using ICH Q9 risk management principles, we create a prioritized remediation roadmap that addresses critical vulnerabilities first.
Governance Framework Development
Development of comprehensive data governance policies, procedures, and controls including data ownership definitions, integrity standards, audit trail requirements, and accountability frameworks tailored to your organization.
Technical Remediation
Implementation of technical controls including system configuration for audit trails, access control setup, electronic signature implementation, and integration of data integrity features into existing systems and workflows.
Training & Culture Development
Role-based training programs for all staff levels, from operators to leadership. We focus on building genuine data integrity culture—understanding why integrity matters, not just what rules to follow.
Ongoing Monitoring & Maintenance
Establishing periodic review schedules, audit trail review procedures, self-inspection programs, and continuous monitoring to sustain data integrity as systems and regulations evolve.
Common Data Integrity Findings We Address
Regulatory agencies consistently cite these data integrity issues. Our assessments proactively identify and remediate these vulnerabilities.
Audit Trail Deficiencies
Missing, incomplete, or unreviewed audit trails; disabled audit trail functionality; failure to capture required metadata.
Shared User Accounts
Multiple users sharing login credentials, preventing attribution of data entries and system actions to individuals.
Inadequate Access Controls
Users with excessive system privileges; administrators able to modify data without oversight; lack of segregation of duties.
Data Deletion Without Controls
Ability to delete original data, test results, or electronic records without proper authorization and documentation.
Backdating & Time Manipulation
System clocks not synchronized; ability to change timestamps; records created after events occurred.
Uncontrolled Spreadsheets
Unvalidated spreadsheets used for GxP calculations; lack of version control, audit trails, or access restrictions.
Frequently Asked Questions About Data Integrity
Expert answers to common questions about ALCOA+, data governance, and regulatory compliance.
Why Data Integrity Matters for UAE Life Sciences
Data integrity has become one of the most scrutinized aspects of regulatory inspections worldwide. For pharmaceutical, biotech, and medical device companies in the UAE and GCC, maintaining robust data integrity practices is essential for both local compliance and access to international markets. FDA warning letters citing data integrity violations have increased dramatically, and such findings can result in import alerts, consent decrees, and lasting reputational damage.
Beyond regulatory compliance, data integrity is fundamental to good science and sound decision-making. Organizations depend on their data to make critical decisions about product release, patient safety, and business strategy. When data cannot be trusted, the entire foundation of quality-based decision-making collapses. Investing in data integrity is investing in the reliability of every decision your organization makes.
Our approach goes beyond technical fixes to build genuine data integrity culture. We help organizations understand that data integrity is not a burden imposed by regulators, but a fundamental aspect of doing good science and protecting patients. When your team understands why data integrity matters, compliance becomes a natural outcome rather than a checkbox exercise.
Related Services
Ready to Achieve Compliance Excellence?
Whether you're facing an audit, implementing new systems, or building AI solutions for regulated environments—we're here to help.
Free initial consultation • No obligation • UAE & GCC focused