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“Labeling and packaging issues are the cause of 33 percent of medication errors, including 30 percent of fatalities.”   
                                               
Institute of Medicine of the National Academies

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Verification and Validation

enLabel's verification and validation services ensure that your packaging systems output complies with predetermined standards and specifications.

The first step in the verification process is to create a master plan by gathering information about all standards that effect the project, both internal and external. This includes specifications for installation, operations, performance, business systems, regulatory requirements, etc. This information is then used to establish comprehensive business rules and requirements to use as a baseline from which to judge compliance.

Verification and Validation Highlights

  • Developing & Executing the Validation Master Plan

  • Installation Qualification (IQ)

  • Operational Qualification (OQ)

  • Performance Qualification (PQ)

  • Business System Qualification (BQ)

  • Regulatory Qualification (RQ)

  • Validation Final Reports

Compliance Expertise FDA 21 CFR Part 11, EU MDD, OSHA, DOT, GMP, and UDI

 

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