Operational qualification

Evosep offers modular maintenance and qualification
services for regulated laboratories and those maintaining
high quality standards.

Have a technical issue? Contact support or access online troubleshooting

Evosep Qualification Service Offerings

In addition to our service plans, Evosep offers modular maintenance and qualification services for regulated laboratories and those maintaining high quality standards.

Operational Qualification (OQ):

The Operational Qualification ensures the Evosep separations system will function within its operational specifications and is fit for its intended use.

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System qualification is essential for:

– Accredited and regulated laboratories –

– Laboratories with high quality standards –

– Performing tests for future clinical approval –

– Managing scientific data risk effectively –

Adapted from USP <1058>

Analytical Instrument Qualification is the Foundation of Data Quality

Analytical Instrument Qualification (AIQ) ensures data quality by verifying that instruments perform as intended.

The Evosep One OQ was designed to meet the requirements of US Pharmacopeia (USP) <1058> on Analytical Instrument Qualification (Group C). 

    Why Qualify your Evosep One?

    A Qualified and Standardized system offers peace of mind through:

    • Assuring data confidence
    • Being approved for use by Quality Department1
    • Saving time on quality test evaluations and reports
    • Meeting requirements and demonstrating compliance to laboratory quality standards
    • Minimising the risk of downtime through regular Preventative Maintenance (PM) and OQs

    1 Evosep cannot guarantee suitability for any specific quality regulation in the user laboratory and will work with users to facilitate their evaluation.

      “The Evosep OQ contains exactly what we need for our instrument qualification.”

      Quality Assurance Manager

      Biotech Company

      Frequently asked questions

      We understand that selecting the right solutions for your laboratory can come with many questions. Our FAQ section is here to provide clear and concise answers to the most common inquiries about our services and qualifications. 

      Do I need Qualification?

      In regulated laboratories it is a requirement that processes are validated, however it is not needed in all labs. It is valuable for labs where high data confidence is needed to:

      • comply with regulations
      • make critical decisions
      • supply data with certification
      • reduce risk
      How does the Evosep qualification service support me meeting my GMP/GLP quality requirement?

      GLP, GMP and other GxP requirements require qualification of systems as the foundation of data quality.

      Evosep OQ

      • Is designed to meet USP <1058> Analytical Instrument Qualification requirements
      • Is a tool to support users in maintaining their quality accreditations
      • Testing plans can be shared for evaluation and approval in advance (contact Sales)
      • Delivers a fully automated and tamper-proof report
      How close is the Evosep One OQ evaluation to the use of the system?

      Evosep OQ is customized to match closely to Evosep One analytical use

      • including testing the system with the same method solvents A and B
      • Evaluation focuses on the ranges of flow rates and gradient compositions used in Evosep One methods
      • Comprehensive testing evaluates all aspects of use from sample introduction to gradient composition

      Do you have a technical question? 

      Our service engineers are here to guide you through any technical difficulties you may encounter, ensuring a smooth and productive experience with Evosep. Simply fill out the request form, and a member of our support team will reach out to assist you promptly. For more information about our qualification services and service plans, please reach out to sales@evosep.com. 

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