Validation

Micro office

The Micro Assurance Advantage

When you choose Micro, you're choosing a team dedicated to ensuring two critical components of the manufacturing process -- Quality and Validation.

Throughout the entire process, we focus on giving full support to your product and machine development needs, standards, and requirements.

Our experienced Engineers and Machine Builders understand your business requirements, and track the progress of your project with validation and approval at each stage.

Machine Validation

  • Good Automated Manufacturing Practice (GAMP) Compliant
    • Support CE or FDA requirements to complete & document manufacturing process validations per:
      • 21 CFR Part 820 (Quality System Regulations)
      • 21 CFR Part 11 (Electronic Records; Electronic Signatures)
    • Support Factory Acceptance Test (FAT) & Site Acceptance Test (SAT) requirements

Machine Certification

  • CE and UL Certification are available upon request
    • Micro works with several 3rd party evaluation companies for the testing
  • CE Marking
    • Micro can support you whether the machine needs to be CE Mark ready or CE Marked
  • UL Testing
    • Micro can UL mark the electrical panels only or work to certify the entire machine
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