Solutions

Validation

IDC offers a full range of regulatory compliance and validation services for new facilities, existing facilities, upgrades to existing facilities, or response to issues raised during regulatory inspections. We provide qualified personnel for a fully integrated validation program or for a specific validation service as required.

Expertise includes:

• GMP Regulatory Compliance Consultancy
  

• Generation of Validation Master Plans
  

• Review of Facility Design
  

• Integration of Validation Schedule into Design & Construction

• Schedule
  

• Liaison with Regulatory Authorities
  

• Regulatory Risk Assessments
  

• Generation of Design, Installation, Operation & Performance

• Qualification Protocols
  

• Establishment of Documentation Management Systems
  

• Field Execution of Protocols
  

• Validation Turnover Packages
  

• Deviation Identification and Resolution
  

• Final Validation Summary Reports