Computer System Validation

Overview

Computerized systems used in regulated environments must be appropriately specified, configured, tested, controlled, and maintained to ensure reliable operation and protection of GxP data.

Mediature GxP Solutions Pvt. Ltd. (MGS) supports pharmaceutical, biopharmaceutical, API, medical-device, laboratory, pharmacovigilance, and other regulated organizations with Computer System Validation (CSV) across the full system lifecycle.

Our approach combines intended use, GxP impact, quality risk management, supplier oversight, data integrity, security, electronic records, testing, change control, periodic review, and system retirement to help clients establish and maintain compliant computerized systems.

Our Computer System Validation Services

CSV Strategy & Planning

Development of system-specific validation strategies defining scope, responsibilities, risk level, documentation requirements, testing approach, supplier involvement, and lifecycle controls.

GxP Impact Assessment

Assessment of whether and how the computerized system may affect product quality, patient safety, regulatory records, or data integrity.

User Requirement Specification

Development or review of clear, testable user requirements covering business, quality, security, data, regulatory, and operational needs.

System Risk Assessment

Risk-based evaluation of system functions to determine the level and depth of validation and testing required.

Supplier Assessment

Evaluation of software vendors and service providers, including development practices, quality systems, support arrangements, documentation, security, and lifecycle responsibilities.

Configuration & Specification Review

Review of system configuration, functional specifications, workflows, roles, interfaces, calculations, and critical settings.

Validation Testing

Development, review, and execution support for risk-based test scripts covering critical functionality, workflows, security, data handling, alarms, interfaces, and other GxP-relevant functions.

Traceability Management

Linkage of requirements, risks, specifications, test cases, deviations, and final validation conclusions.

Validation Summary & Release

Preparation or review of validation reports confirming completed activities, deviations, outstanding actions, and readiness for controlled operational use.

Periodic Review & Continued Validation

Support for periodic evaluation, change control, access review, incidents, deviations, system performance, supplier changes, and continued validated-state assessment.

System Retirement

Support for controlled decommissioning, data migration, archival, retention, accessibility, and retirement documentation.

Systems We Can Support

Depending on project scope, MGS can support validation of:

• Electronic Quality Management Systems
• Electronic Document Management Systems
• Learning Management Systems
• Laboratory Information Management Systems
• Manufacturing Execution Systems
• Enterprise Resource Planning systems
• Pharmacovigilance databases
• Regulatory systems
• Electronic batch-record systems
• Laboratory instruments and associated software
• Chromatography data systems
• Building Management Systems
• Environmental Monitoring Systems
• Stability-management systems
• Warehouse-management systems
• Cloud-based GxP applications
• Customized or configured software
• System interfaces and APIs

Key CSV Considerations

MGS may assess:

• Intended use
• GxP criticality
• Patient-safety impact
• Product-quality impact
• Data-integrity risk
• System architecture
• User roles and permissions
• Authentication
• Electronic records
• Electronic signatures
• Audit trails
• Data storage
• Backup and recovery
• Interfaces
• Data migration
• Configuration
• Calculations
• Reports
• Workflow controls
• Security
• Vendor controls
• Incident management
• Change control
• Periodic review
• Business continuity
• Disaster recovery
• Data archival
• System retirement

Our CSV Approach

• Understand

Define the business process, system functionality, intended use, users, data, interfaces, and applicable GxP requirements.

• Assess

Determine system criticality and identify risks to product quality, patient safety, regulatory compliance, and data integrity.

• Plan

Establish validation scope, documentation, responsibilities, test strategy, acceptance criteria, and supplier involvement.

• Verify

Execute or support risk-based testing of critical functionality, configuration, security, workflows, interfaces, and data controls.

• Release

Review completed evidence, deviations, procedures, training, security controls, and approvals before operational use.

• Maintain

Support incidents, changes, periodic review, access management, backup verification, audit-trail controls, and continued validated state.

• Retire

Ensure controlled decommissioning and appropriate retention, migration, archival, and accessibility of required records.

CSV Deliverables

Depending on scope, MGS can provide:

• Validation Plan
• GxP Impact Assessment
• System Risk Assessment
• User Requirement Specification
• Functional or configuration specification review
• Supplier assessment
• Validation test strategy
• Test scripts
• IQ/OQ/PQ or equivalent test documentation
• Traceability matrix
• Deviation documentation
• Validation Summary Report
• Change-impact assessments
• Periodic-review reports
• System-retirement plan
• Validation status tracker

Why Choose MGS

Risk-Based Validation

MGS focuses validation effort on functions and data that are critical to GxP operations.

Lifecycle Perspective

Support can extend from system selection and implementation through operation, upgrade, migration, and retirement.

Data-Integrity Focus

Validation activities consider data generation, processing, review, storage, security, retrieval, and retention.

GxP & Technical Understanding

Our approach integrates quality, regulatory, business-process, IT, and system-control perspectives.

Practical Documentation

MGS focuses on clear, traceable, and usable validation documentation aligned with the actual system and business process.

Who We Support

MGS can provide CSV support for:

• Pharmaceutical manufacturers
• API manufacturers
• Biopharmaceutical organizations
• Medical-device companies
• Laboratories
• CROs
• Pharmacovigilance organizations
• Contract manufacturers
• Quality organizations
• Regulatory teams
• IT and digital teams
• Greenfield projects
• Existing facilities implementing or upgrading GxP systems