Focusing on risk based approach, we identify the correct level of validation for your equipment process, facility, and computer systems. We have experience authoring executing and summarizing validations:

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  • Master Validation Plan
  • Legacy System Validation Remediation
  • Equipment Qualification, Validation and Commissioning
  • Test Method Validation, Process Validation, Cleaning Validation
  • Qualification Protocol (IQ, OQ, PQ) Development
  • System Gap Analyses and Audits
  • Risk Assessment
  • Remediation Plan Implementation