Yoh Validation Services Include: 

Process Validation Services

Yoh Services helps clients adhere to FDA guidelines and expectations on Process Validation.

Guidelines include a three-stage lifecycle approach:

• Process Design
• Process Qualification 
• Continued Process Verification

Cleaning Validation Services

Yoh Services adheres to these cleaning validation guidelines:

• Critical Process Cleaning
• Cleaning Validation Master Plan
• Cleaning Validation Protocol Development

Computer System Validation

• Project Initiation and Planning
• System Development and Verification
• System Requirements and Design
• System Type Expertise:
  • Building, Facility, Utility Control Systems
  • Manufacturing Process Control Systems
  • Manufacturing Execution Systems
  • Laboratory Data Acquisition and Information Systems
  • Quality Workflow and Document Management Systems

Yoh Qualification Services Include:

• Validation Master Plan (VMP)
• Risk Analyses
• Commissioning (FAT, SAT)
• Integrated Commissioning and Qualification
• Leveraging Strategies
• Qualification Plans for all Phases of a Life Cycle:
  • DQ, IQ, OQ, PQ
• Execution of Qualification Plans
• Preparation of Qualification Reports
• Preparation of GMP Documentation
• Re-qualification and Periodic Review
• Establishing Change Control Processes

Yoh Compliance Services Include:

• FDA Remediation Services
• Master Planning
• Regulatory Interpretation
• Meeting w/Regulatory Authorities
• Inspection Readiness
• Quality System Development and Improvement
• Standards Assessments Including Gap Analysis
• Supplier Quality Management Program Implementation
• Auditing (cGMP, Supplier, Internal, Process)
• Document Management System Assessments and Implementations
• Investigation and Root Cause Analysis Program Implementation
• Quality Risk Management Program Deployment
• Quality Management Review Implementation
• Regulatory Submissions and Strategy (510k, PMA, NDA, BLA, IND, etc.)
• Post Approval Activities
• Compliance Remediation