Data Integrity Assessment

Overview

Data integrity is fundamental to pharmaceutical and life-sciences quality systems because regulatory decisions, product release, investigations, validation, safety activities, and operational decisions depend on reliable data.

Mediature GxP Solutions Pvt. Ltd. (MGS) supports pharmaceutical, biopharmaceutical, API, medical-device, laboratory, pharmacovigilance, and other regulated organizations with data-integrity assessments covering paper records, electronic systems, laboratory data, manufacturing records, quality systems, and computerized processes.

Our approach evaluates data governance, ALCOA+ principles, user access, audit trails, record creation, review, modification, storage, backup, retrieval, archival, system controls, procedures, and personnel practices to identify vulnerabilities and support practical remediation.

Our Data Integrity Services

Data Integrity Gap Assessment

Structured review of systems, processes, documentation, and practices to identify weaknesses that may affect the reliability or trustworthiness of GxP data.

ALCOA+ Assessment

Evaluation of whether data are appropriately:

• Attributable
• Legible
• Contemporaneous
• Original
• Accurate
• Complete
• Consistent
• Enduring
• Available

Data Governance Review

Assessment of organizational responsibilities, policies, procedures, ownership, oversight, escalation, and management controls related to data integrity.

Electronic System Assessment

Evaluation of computerized systems used to generate, process, review, store, or report GxP data.

Audit Trail Assessment

Review of audit-trail availability, configuration, retention, review frequency, responsibilities, and handling of critical events.

User Access & Security Review

Assessment of user accounts, role-based access, administrator privileges, shared accounts, password controls, and user lifecycle management.

Laboratory Data Integrity Assessment

Review of laboratory practices, instruments, chromatography systems, worksheets, calculations, raw data, metadata, review processes, and result reporting.

Manufacturing Data Integrity Assessment

Assessment of manufacturing records, equipment-generated data, process parameters, logbooks, electronic records, and production documentation.

Paper Record Assessment

Review of handwritten entries, corrections, controlled forms, worksheets, logbooks, transcription practices, and original-record management.

Data Lifecycle Review

Evaluation of controls from initial data generation through processing, review, approval, reporting, storage, archival, retrieval, and eventual retention or disposal.

Remediation Support

Development and implementation support for corrective actions addressing identified data-integrity gaps.

Key Areas We Assess

Depending on scope, MGS may review:

• Data governance
• Roles and responsibilities
• Original data
• Metadata
• Audit trails
• Electronic records
• Paper records
• Hybrid systems
• User access
• Administrator privileges
• Shared accounts
• Password controls
• Data modification
• Deletion controls
• Data review
• Second-person verification
• Calculations
• Transcription
• Manual entries
• Backdating risks
• Blank forms
• Logbooks
• Worksheets
• Backup
• Restore capability
• Data retention
• Archival
• Retrieval
• System interfaces
• Data migration
• Incident management
• Change control
• Training
• Periodic review

Common Data Integrity Risk Areas

Organizations may encounter issues such as:

• Shared login credentials
• Excessive administrator access
• Disabled or poorly configured audit trails
• Incomplete review of audit-trail data
• Uncontrolled worksheets
• Missing original records
• Manual transcription without verification
• Inadequate backup controls
• Editable electronic records without adequate controls
• Uncontrolled deletion or overwriting of data
• Incomplete documentation of corrections
• Poor metadata retention
• Weak record-review practices
• Inadequate archival arrangements
• Lack of clear data ownership
• Inadequate oversight of hybrid paper/electronic systems

Our Assessment Approach

• Define Scope

Identify relevant departments, systems, records, processes, data flows, and critical GxP activities.

• Map the Data Lifecycle

Understand how data are generated, recorded, processed, reviewed, approved, stored, transferred, archived, and retrieved.

• Assess Controls

Evaluate technical, procedural, organizational, and behavioral controls against applicable data-integrity expectations.

• Identify & Classify Gaps

Document weaknesses and prioritize them according to potential impact on product quality, patient safety, regulatory compliance, and data reliability.

• Develop Remediation Actions

Recommend practical corrective and preventive measures covering systems, procedures, governance, training, or technical controls.

• Verify Improvement

Support implementation review, CAPA effectiveness, follow-up assessment, and continued data-integrity monitoring.

Deliverables

Depending on scope, MGS can provide:

• Data Integrity Assessment Report
• ALCOA+ assessment
• Department-wise gap analysis
• Computerized-system assessment
• Audit-trail assessment
• User-access assessment
• Data lifecycle map
• Risk classification
• Remediation roadmap
• CAPA recommendations
• SOP recommendations
• Training recommendations
• Follow-up assessment
• Compliance action tracker

Why Choose MGS

End-to-End Data Lifecycle Perspective

MGS evaluates data from initial creation through review, storage, archival, and retrieval rather than focusing only on individual system features.

Paper & Electronic Data Coverage

Our assessments can include paper-based, electronic, and hybrid GxP environments.

Risk-Based Prioritization

Findings are prioritized based on their potential impact on data reliability, product quality, patient safety, and compliance.

CSV & Quality Integration

Data integrity is assessed together with computerized-system validation, document controls, quality systems, and operational practices.

Practical Remediation

Recommendations focus on sustainable improvements that can be implemented within actual operational environments.

Who We Support

MGS can provide data-integrity assessment support for:

• Pharmaceutical manufacturers
• API manufacturers
• Biopharmaceutical organizations
• Medical-device companies
• Quality-control laboratories
• Research and development laboratories
• CROs
• Pharmacovigilance organizations
• Contract manufacturers
• Quality departments
• IT and digital teams
• Sites preparing for regulatory inspections
• Organizations undergoing data-integrity remediation