Quality & Compliance

At XiltriX, quality and compliance are at the core of our operations. Our fully validatable system is designed to meet 21 CFR Part 11 standards. Our mature validation protocols, documentation and support significantly reduce the burden, time and cost of validation for your Quality team.

Does Your Team Need Audit Support?

We understand the importance of having data readily available and being able to quickly generate required reports during an audit. Our SafetyNet team can provide additional training in preparation for an audit, or provide live expert assistance with producing last minute reports, logs or statistics during an audit at no additional cost. The XiltriX SafetyNet is there for you when you need them most.

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XiltriX Supports Compliance

  • Validation Support Services

    Our validation support services include the provision of well-vetted specifications, testing, and evidence documentation, as well as a smooth and efficient execution of the IQ and OQ components. This removes a significant burden from your quality organization and makes validation fast and efficient.

  • FDA 21 CFR Part 11

    The XiltriX system complies with the FDA’s directives on the trustworthiness, reliability, integrity, and auditability of electronic records.

  • AABB

    XiltriX supports compliance with the American Association of Blood Banks (AABB). This aspect of compliance is related to all aspects of how blood banks handle collections.

  • CLIA

    XiltriX supports compliance with the Clinical Laboratory Improvement Amendments (CLIA). Compliance related to how laboratories test human samples.

  • Joint Commission

    XiltriX supports compliance with the Joint Commission. This organization seeks to continuously improve health care for the public and evaluates health care organizations to ensure highest quality and safety.

  • GxP

    XiltriX supports compliance by following a 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.

  • AAALAC

    XiltriX supports compliance with the Association for Assessment and Accreditation for Laboratory Animal Care (AAALAC). These standards are set to ensure proper use of animals in research, testing, and teaching.

  • CAP

    XiltriX supports compliance with the College of American Pathologists (CAP). These regulations and guidelines are for laboratories to ensure best practices.

  • HAACCP

    XiltriX supports compliance with the Hazard Analysis and Critical Control Points (HAACCP). This systematic preventive approach helps ensure food safety.

  • USP 797

    XiltriX supports compliance with the United States Pharmacopeia (USP). They set enforceable sterile compounding standards for compounding pharmacies and facilities. Chapter 797 concentrates on the safety and protection of patients and healthcare staff.

Our Commitment To Compliance

  • SOC 2 TYPE 2

    Achieving SOC 2 Type 2 is a testament to our commitment to safeguarding sensitive information and ensuring the highest level of data protection and compliance. We work with an independent auditor to maintain our SOC 2 reports and follow the Trust Services Criteria created by the Assurance Services Executive Committee (ASEC) of the American Institute of Certified Public Accounts (AICPA).

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  • ISO 9001:2015 Certified QMS

    XiltriX’s ISO 9001:2015 QMS certificate was issued by Amtivo (USA) Inc., a provider of third-party system registration and accredited by the ANSI National Accreditation Board. Our certification includes designs, installs, and maintains a real-time monitoring system to provide its Monitoring-as-a-Service solution to organizations.

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