Qualification and Validation

Among the activities offered we can highlight:

• Validation Master Plan.
• Specific Validation Plan (Process Validation, Equipment Qualification…).
• User Requirements.
• Functional and Technical Specifications.
• Risk Analysis.
• Standard Operating Procedures related to the Qualification/Validation area as well as GMP.
• Commissioning (FAT & SAT).
• Equipment Qualification (Design, Installation, Operation and Performance Qualification).
• Utilities Qualification (Water System, Compressed Air, HVAC and others).
• Thermal Qualification.
• Computerized Systems Validation: Business Systems Validation (ERP, SCM, CRM, etc); Plant Operation Systems (MES, LIMS, WMS, etc) and Automation Systems (SCADA, DCS, PLC, etc); and Electronic Spreadsheets.
• Process Validation.
• Cleaning Validation.
• Analytical Methodology Validation.
• Transport Validation (Cold Chain).
• Traceability Matrix.