CSV & Digitalization

Systems We Can Support

Depending on project scope, MGS can support systems such as:

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

Key CSV & Digital Compliance Challenges

Organizations may face challenges such as:

• Incomplete validation documentation
• Weak user requirements
• Excessive or insufficient testing
• Poor risk-based justification
• Inadequate supplier assessment
• Uncontrolled system changes
• Weak audit-trail review
• Data-integrity gaps
• Inadequate access control
• Shared user accounts
• Incomplete backup and recovery controls
• Poor data migration verification
• Unvalidated interfaces
• Lack of periodic review
• Inadequate system retirement controls
• Unclear responsibilities between users, IT, vendors, and quality teams

Our CSV Lifecycle Approach

• Understand

Define the system, intended use, business process, GxP impact, data criticality, users, interfaces, and regulatory requirements.

• Assess Risk

Determine system criticality and identify functions that may affect product quality, patient safety, data integrity, or regulatory compliance.

• Plan

Establish validation strategy, responsibilities, documentation, testing approach, supplier involvement, and acceptance criteria.

• Configure & Verify

Review configuration and support risk-based functional testing, integration testing, security verification, and data-integrity controls.

• Release

Confirm that documentation, deviations, testing, training, security, procedures, and approvals support controlled system use.

• Maintain

Support change control, incident management, periodic review, access review, audit-trail review, backup, recovery, and continued validated state.

• Retire

Support controlled system decommissioning, data migration, archival, record retention, and continued data accessibility.

Typical CSV Deliverables

Depending on scope, MGS can provide:

• Validation Plan
• System risk assessment
• GxP impact assessment
• User Requirement Specification
• Functional or configuration specifications
• Supplier assessment
• Traceability matrix
• Test strategy
• IQ/OQ/PQ or equivalent lifecycle testing
• Functional test scripts
• Interface test scripts
• Security and access-control testing
• Data-migration plan and report
• Data-integrity assessment
• Part 11 / Annex 11 assessment
• Validation Summary Report
• Periodic-review report
• Change-impact assessment
• System-retirement plan
• Validation status tracker

Regulatory & Compliance Perspective

Depending on the system and intended use, MGS support may consider applicable expectations associated with:

• US FDA 21 CFR Part 11
• EU GMP Annex 11
• GAMP 5
• Data-integrity principles
• ICH quality-system and risk-management principles
• Applicable WHO guidance
• MHRA data-integrity expectations
• PIC/S requirements
• Revised Schedule M
• Other applicable national and international GxP requirements

What Sets MGS Apart

Risk-Based Validation

MGS focuses testing and documentation on functions that are critical to quality, safety, compliance, and data integrity.

GxP & Technology Integration

Our approach considers both regulated business processes and technical system controls.

Data-Integrity Focus

CSV activities are integrated with access control, audit trails, data lifecycle, security, backup, recovery, and record-retention requirements.

Lifecycle Support

MGS can support systems from initial implementation through operation, change, periodic review, upgrade, migration, and retirement.

Practical Documentation

Our focus is on clear, usable, traceable validation documentation rather than unnecessary documentation volume.

Who We Support

MGS can provide CSV and digitalization support for:

• Pharmaceutical manufacturers
• API manufacturers
• Biopharmaceutical organizations
• Medical-device companies
• Laboratories
• Pharmacovigilance organizations
• Contract manufacturers
• CROs
• Quality and regulatory teams
• IT and digital-transformation teams
• Greenfield facilities
• Existing sites undergoing system implementation, upgrade, migration, or remediation