Computerized System / CSV Audits

Overview

Computerized systems are integral to modern GxP operations and can directly influence product quality, patient safety, regulatory compliance, and data reliability.

Mediature GxP Solutions Pvt. Ltd. (MGS) provides independent computerized-system and data-integrity audits for pharmaceutical, biopharmaceutical, medical-device, laboratory, clinical, pharmacovigilance, and other regulated organizations.

Our audits assess whether computerized systems are appropriately validated, securely controlled, properly governed, and capable of maintaining complete, accurate, attributable, and traceable GxP records throughout the data lifecycle.

MGS follows a risk-based approach to identify gaps in system validation, access control, audit trails, electronic records, data review, backup, archival, and governance.

Our Audit Services

Computerized System Audits

Assessment of GxP computerized systems to evaluate validation status, system controls, documentation, governance, and operational compliance.

Data Integrity Audits

Evaluation of paper and electronic data practices across the complete data lifecycle, including generation, processing, review, storage, retrieval, retention, and archival.

CSV Compliance Audits

Review of Computer System Validation activities, including requirements, risk assessment, specifications, testing, traceability, release, change management, and periodic review.

21 CFR Part 11 Compliance Assessments

Assessment of electronic records and electronic-signature controls against applicable 21 CFR Part 11 requirements.

EU Annex 11 Assessments

Review of computerized-system controls against applicable EU GMP Annex 11 expectations.

Audit Trail Review Assessments

Evaluation of audit-trail configuration, review practices, user actions, data changes, exceptions, and documentation.

User Access & Security Audits

Assessment of role-based access, user provisioning, privileged accounts, segregation of duties, password controls, and periodic access review.

Data Migration & Interface Audits

Evaluation of data mapping, migration controls, reconciliation, verification, interface integrity, and transfer accuracy between computerized systems.

Cloud & SaaS System Audits

Assessment of cloud-based GxP applications, supplier controls, hosting arrangements, security, backup, availability, change management, and shared responsibilities.

Computerized-System Vendor Audits

Independent assessment of software vendors, hosting providers, cloud-service providers, and other technology partners supporting GxP systems.

Key Audit Focus Areas

Depending on the audit scope, MGS may assess:

• System inventory and GxP classification
• Validation status
• User Requirement Specifications
• Functional and design documentation
• Risk assessments
• Test scripts and execution evidence
• Traceability
• System configuration
• User-access management
• Privileged-access controls
• Password and security controls
• Audit trails
• Electronic signatures
• Data review and approval
• Backup and restoration
• Disaster recovery
• Business continuity
• Data migration
• System interfaces
• Change control
• Incident and deviation management
• Periodic review
• Supplier qualification
• System retirement
• Data retention and archival
• Data governance
• Good documentation practices
• ALCOA+ principles
• Cybersecurity controls relevant to GxP data
• Training and system administration

Data Integrity Perspective

MGS evaluates whether GxP data remain:

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

Audit activities focus on both technical controls and human processes that may affect the reliability and traceability of regulated data.

Applicable Compliance Perspective

Depending on the system and regulatory environment, assessments may consider applicable requirements and expectations associated with:

• 21 CFR Part 11
• EU GMP Annex 11
• GAMP 5 principles
• WHO data-integrity guidance
• MHRA data-integrity expectations
• PIC/S guidance
• Applicable GMP and GxP requirements
• ALCOA+ data-integrity principles
• Other relevant national and international expectations

Our Audit Process

• Define Scope

Understand the system, intended use, GxP impact, business process, data flows, interfaces, users, vendors, and applicable regulatory requirements.

• Prepare

Review system documentation, validation records, procedures, architecture, access controls, and previous findings to develop a risk-based audit plan.

• Assess

Evaluate the system through interviews, document review, configuration checks, audit-trail review, access review, record sampling, and evidence verification.

• Evaluate

Assess observations based on their potential impact on data integrity, product quality, patient safety, compliance, and business continuity.

• Report

Provide a structured audit report with observations, evidence, compliance significance, and recommended improvement areas.

• Follow Up

Where required, support remediation planning, CAPA review, validation improvement, periodic review, and follow-up assessment.

Audit Deliverables

Depending on scope, MGS can provide:

• Audit plan and agenda
• Computerized-system compliance assessment
• Data-integrity gap assessment
• Validation-document review
• Audit-trail assessment
• Access-control review
• Detailed audit report
• Observation summary
• Risk-based finding classification
• CAPA review support
• Remediation recommendations
• Follow-up audit support

Why Choose MGS for Computerized System & Data Integrity Audits

Integrated CSV & Quality Expertise

Our approach combines computerized-system validation, quality-system, regulatory, and data-integrity perspectives.

Risk-Based Assessment

Audit effort is focused on systems and controls with the greatest potential impact on GxP data and regulated operations.

Lifecycle Perspective

MGS evaluates the full computerized-system lifecycle from selection and implementation through validation, operation, change, periodic review, and retirement.

Practical Findings

Observations are presented clearly to help clients understand the gap, associated risk, and required area of improvement.

Vendor & Cloud System Coverage

MGS can assess internal applications as well as external software vendors, cloud systems, hosting providers, and outsourced technology services.

Systems We Can Assess

MGS can support audits of systems such as:

• Laboratory Information Management Systems
• Electronic Quality Management Systems
• Document Management Systems
• Enterprise Resource Planning systems
• Manufacturing Execution Systems
• Building Management Systems
• Environmental Monitoring Systems
• Chromatography Data Systems
• Laboratory instruments with computerized functions
• Safety and pharmacovigilance databases
• Clinical systems
• Training Management Systems
• Cloud and SaaS platforms
• Other GxP computerized applications