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Validation

Our validation specialists are trained in current Good Manufacturing Practices (cGMP) and have experience implementing them in the Pharmaceutical, Food & Beverage, Consumer Products and Chemical Industries. Integrating commissioning and validation with design engineering and scheduling allows our validation specialists to have input from conceptual design through turnover, resulting in the design and construction of a validatable facility or system.

Process Plus works directly with our clients’ engineering personnel to improve their operations and provide thorough cGMP documentation of compliance to federal regulations.

Our Validation Specialists have provided complete validation services including validation project management and coordination as well as document development from Validation Master Planning through Validation Summary Reports. We have successfully validated cGMP facilities, equipment, utilities, and HVAC systems / environmental conditions found in manufacturing, packaging and storage areas.



Validation Services We Offer:

  • Consulting
  • cGMP Compliance Audits
  •  Equipment File Audits
  • Gap Analyses
  • FDA Audit Preparation
  • Validation Master Plans (VMP
  • System Impact Matrices
  • Commissioning Plans (CP)
  • Turnover Package Requirements (TOP)
  • Validation Schedule
  • Design Qualification (DQ)
  • Factory & Site Acceptance Tests (FAT/SAT)
  • System Validation Plans
  • GAMP Specifications (UR/FS/DS)
  • Trace Matrices
  • Installation Qualifications (IQ)
  • Operational Qualifications (OQ)
  • Performance Qualifications (PQ)
  • Standard Operating Procedures (SOPs)