Compliance is about proper practices and accurate reporting. With XiltriX, we help ensure both.
Our service provides the hardware and software that help organizations reach and maintain compliance, control, and peace-of-mind as well as custom reports that help prove compliance.
FDA regulation for electronic documentation and electronic signatures
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
Good Automated Manufacturing Practice. ISPE’s guide for validation of automated systems in pharmaceutical manufacturing
Compliant with Association for Assessment and Accreditation for Laboratory Animal Care. Set of standards for proper use of animals in research, testing, and teaching
Accredited by American Association of Blood Banks. Compliance related to all aspects of how blood banks handle collections
Compliant with College of American Pathologists. Set of regulations and guidelines for laboratories to ensure best practices
Compliant with Clinical Laboratory Improvement Amendments. Compliance related to how laboratories test human samples
Compliant with Hazard Analysis and Critical Control Points. Systematic preventive approach to ensure food safety
The Joint Commission seeks to continuously improve health care for the public and evaluates health care organizations to ensure highest quality and safety
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
Our SOC 2 Type 1 certification 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 AICPA.
XiltriX’s ISO 9001:2015 certificate was issued by American Systems Registrar, LLC, a provider of third-party system registration and accredited by the ANSI National Accreditation Board. XiltriX’s certification includes designs, installs, and maintains a real-time monitoring system to provide its Monitoring-as-a-Service solution to organizations.