Design Group > Services > Validation & Regulatory Compliance

Validation & Regulatory Compliance

Design Group is a leading supplier of Validation and Regulatory Consulting Services to the Biotech, Pharmaceutical, and Medical Device industries. Combining the GAMP life-cycle methodology with strong internal procedures, Design Group Validation and Regulatory Services team delivers flexible and diverse validation packages.

Our broad capabilities encompass master plans, specifications and commissioning, as well as protocol development, execution and summarization for utilities, equipment, computer, laboratory and cleaning systems. In addition to comprehensive quality system audits, we conduct 21CFR-11 gap analyses and implement remediation programs.

Design Group provides the technical resources and industry-experienced insight for a Total Operational Solution to your most challenging business requirements.

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Validation Regulatory Compliance

Services and Capabilities

  • Validation Master Plans
  • cGMP Auditing Services
  • Specifications Development
  • Equipment / Systems Commissioning
  • Equipment Qualification
  • Process Validation
  • Cleaning Validation
  • 21CFR-11 Compliance
  • Laboratory Qualification
  • Enterprise Software Validation
  • Lab Methods Validation
  • Facilities Qualifications

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