XiltriX complies with:

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  FDA 21 CFR Part 11 Compliant

  FDA regulation for electronic documentation and electronic signatures

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  GxP

  Collection of quality guidelines and regulations to ensure bio/pharma products are safe, meet intended use, and adhere to quality standards throughout the supply chain

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  GAMP

  Good Automated Manufacturing Practice. ISPE’s guide for validation of automated systems in pharmaceutical manufacturing

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  AAALAC

  Compliant with Association for Assessment and Accreditation for Laboratory Animal Care. Set of standards for proper use of animals in research, testing, and teaching

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  AABB

  Accredited by American Association of Blood Banks. Compliance related to all aspects of how blood banks handle collections

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  CAP

  Compliant with College of American Pathologists. Set of regulations and guidelines for laboratories to ensure best practices

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  CLIA

  Compliant with Clinical Laboratory Improvement Amendments. Compliance related to how laboratories test human samples

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  HAACCP

  Compliant with Hazard Analysis and Critical Control Points. Systematic preventive approach to ensure food safety

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  Joint Commission

  The Joint Commission seeks to continuously improve health care for the public and evaluates health care organizations to ensure highest quality and safety

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  USP 797

  United States Pharmacopeia is a set of enforceable sterile compounding standards for compounding pharmacies and facilities. Chapter 797 is concentrated on the safety and protection of patients and healthcare staff