Commissioning, Qualification & Validation

Key CQV Challenges

Organizations may face challenges such as:

• Incomplete or inconsistent validation documentation
• Weak linkage between URS, risk assessment, testing, and acceptance criteria
• Poor coordination between engineering and validation teams
• Inadequate qualification of utilities or HVAC systems
• Unclear requalification strategy
• Validation gaps following modifications or upgrades
• Weak deviation handling during qualification
• Inadequate process-validation lifecycle management
• Cleaning-validation challenges
• Maintaining validated state after changes
• Insufficient periodic review
• Lack of traceability across qualification and validation documents

Our CQV Approach

• Define

Understand the system, process, intended use, critical requirements, regulatory expectations, and validation objective.

• Assess Risk

Identify critical quality, process, engineering, and compliance risks to determine the appropriate level of qualification and validation.

• Plan

Develop the validation strategy, documentation pathway, responsibilities, protocols, acceptance criteria, and execution plan.

• Execute

Support commissioning, qualification, validation testing, documentation, deviation handling, and evidence collection.

• Review

Evaluate results, deviations, data integrity, acceptance criteria, and overall readiness for release or routine operation.

• Maintain

Support change control, periodic review, requalification, revalidation, and ongoing maintenance of the validated state.    

CQV Deliverables

Depending on scope, MGS can provide:

• Validation Master Plan
• CQV strategy
• User Requirement Specifications
• Risk assessments
• Design review support
• IQ/OQ/PQ protocols
• Commissioning checklists
• Test scripts
• Traceability matrices
• Qualification reports
• Process-validation protocols and reports
• Cleaning-validation protocols and reports
• Deviation assessment
• Requalification strategy
• Periodic-review reports
• Validation status trackers
• Lifecycle documentation support

Regulatory & Compliance Perspective

Depending on the system, process, product, and target market, MGS CQV support may consider applicable expectations associated with:

• US FDA
• EU GMP
• WHO GMP
• MHRA
• PIC/S
• TGA
• ANVISA
• ICH Guidelines
• Revised Schedule M
• GAMP-based principles where computerized systems are involved
• Applicable qualification and validation guidance
• Other relevant national and international requirements

What Sets MGS Apart

Engineering & Validation Integration

MGS combines engineering understanding with qualification, validation, quality, and regulatory perspectives.

Risk-Based Lifecycle Approach

Validation effort is focused on critical systems, functions, and risks rather than unnecessary documentation.

Practical Execution Support

Our services can extend from strategy and protocol development through on-site execution, review, and closeout.

Multidisciplinary Expertise

CQV projects can draw on engineering, quality, manufacturing, laboratory, CSV, EHS, and regulatory expertise.

Documentation Quality

MGS focuses on clear, traceable, inspection-ready documentation that reflects actual system performance and evidence.

Support for New & Existing Facilities

We can support greenfield projects, brownfield modifications, system upgrades, remediation, requalification, and periodic review.

Who We Support

MGS CQV services can support:

• API manufacturing facilities
• Finished dosage form plants
• Sterile manufacturing facilities
• Biopharmaceutical facilities
• Medical-device manufacturing
• Laboratories
• Warehouses
• HVAC and cleanroom systems
• Utility systems
• Manufacturing equipment
• High-potency and containment facilities
• Greenfield projects
• Brownfield expansions and upgrades