GAMP 5 Compliance

Overview

GAMP 5 provides a widely used risk-based framework for managing computerized systems in regulated life-sciences environments. It emphasizes patient safety, product quality, data integrity, intended use, supplier involvement, and appropriate lifecycle controls.

Mediature GxP Solutions Pvt. Ltd. (MGS) supports pharmaceutical, biopharmaceutical, API, medical-device, laboratory, pharmacovigilance, and other regulated organizations with GAMP-aligned system assessment, validation planning, supplier evaluation, risk management, testing, documentation, periodic review, and lifecycle support.

Our approach focuses on applying appropriate effort according to system complexity, criticality, intended use, and risk, helping clients avoid both under-validation and unnecessary documentation.

Our GAMP 5 Compliance Services

GAMP-Based Validation Strategy

Development of validation approaches aligned with system category, intended use, GxP impact, complexity, and risk.

System Classification Support

Assessment and categorization of computerized systems to determine appropriate lifecycle documentation, supplier reliance, testing, and control requirements.

GxP Impact Assessment

Evaluation of how the system may affect:

• Product quality
• Patient safety
• Data integrity
• Regulatory records
• GxP processes

Supplier Assessment

Evaluation of software or service providers based on their quality systems, development practices, documentation, support model, change management, and lifecycle responsibilities.

Risk Assessment

Identification and evaluation of critical system functions, failure modes, data risks, and controls to determine validation and testing priorities.

Lifecycle Documentation

Development and review of documentation across the system lifecycle, including:

• Validation plans
• User requirements
• Specifications
• Risk assessments
• Test scripts
• Traceability matrices
• Validation reports
• Change assessments
• Periodic-review records

Risk-Based Testing

Support for testing strategies focused on critical functions, workflows, interfaces, calculations, security, and data-management controls.

Configuration & Change Control

Assessment of configured functionality and support for controlled system changes throughout the operational lifecycle.

Periodic Evaluation

Support for periodic review of system performance, incidents, changes, user access, backup, supplier status, deviations, and validated-state maintenance.

System Retirement

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

Key GAMP 5 Principles We Consider

MGS may support organizations in applying principles such as:

• Product and process understanding
• Patient safety
• Product quality
• Data integrity
• Science-based quality risk management
• Lifecycle approach
• Scalable validation effort
• Supplier involvement
• Critical thinking
• Efficient testing
• Leveraging supplier documentation
• Configuration management
• Traceability
• Change control
• Periodic evaluation
• Maintaining the validated state

Typical System Areas

GAMP-based approaches may be applied to systems such as:

• eQMS
• EDMS
• LIMS
• MES
• ERP
• LMS
• Pharmacovigilance databases
• Regulatory systems
• Laboratory instruments and software
• Chromatography data systems
• BMS
• EMS
• Warehouse systems
• Cloud-based applications
• Configured commercial software
• Custom applications
• Interfaces and APIs

Our Approach

• Understand the System

Define intended use, users, process, system architecture, interfaces, data, and regulatory relevance.

• Classify & Assess

Determine system type, GxP impact, complexity, criticality, supplier role, and associated risks.

• Define the Lifecycle Strategy

Establish documentation, testing, responsibilities, supplier reliance, traceability, and control requirements.

•  Verify Critical Functions

Perform or support risk-based testing and review evidence for critical system functionality.

• Release

Confirm that requirements, testing, deviations, procedures, training, and controls support operational use.

• Maintain

Support change management, incident review, periodic evaluation, supplier monitoring, access control, and continued validation.

• Retire

Support controlled system retirement while maintaining required data and records.

Deliverables

Depending on scope, MGS can provide:

• GAMP-based validation strategy
• System classification assessment
• GxP impact assessment
• Supplier assessment
• System risk assessment
• Validation plan
• User Requirement Specification
• Functional or configuration review
• Test strategy
• Risk-based test scripts
• Traceability matrix
• Validation Summary Report
• Change-impact assessments
• Periodic-evaluation reports
• System-retirement documentation
• Validation status tracker

Why Choose MGS

Scalable Validation Approach

MGS helps align validation effort with actual system risk and complexity.

Critical-Thinking Focus

Our approach emphasizes meaningful assurance rather than excessive documentation.

Supplier-Leverage Strategy

Where appropriate, MGS helps clients evaluate and leverage reliable supplier activities and evidence.

Data-Integrity Perspective

System lifecycle controls are reviewed in conjunction with data generation, processing, storage, access, review, and retention.

Lifecycle Support

MGS can support computerized systems from initial selection through implementation, operation, upgrade, migration, and retirement.

Who We Support

MGS can provide GAMP 5 compliance support for:

• Pharmaceutical manufacturers
• API manufacturers
• Biopharmaceutical organizations
• Medical-device companies
• Laboratories
• CROs
• Pharmacovigilance organizations
• Contract manufacturers
• Quality teams
• IT and digital teams
• Greenfield projects
• Existing sites implementing or remediating computerized systems