Written by Moises Eilemberg
CEO of XiltriX North America
Companies are on the lookout for regulatory compliance standards when updating SOPs and other processes. We have provided some consultative information about facility regulations when it comes to vivarium monitoring compliance. Comprehensive environmental monitoring systems equip clients with the necessary tools to continuously monitor vivarium conditions during and between clinical trials, ensuring lab compliance standards. When clinical trials yield positive results, it is essential to demonstrate that animals were consistently housed in well-regulated environments throughout the entire process. This substantiates the outcomes and provides the essential data needed for quality control and compliance reporting.
To meet all regulatory compliance standards effectively, certain lab regulations need to be adopted in SOPs. Depending on the jurisdiction (whether the California Dept of Health or the USDA at the Federal level), different regulatory bodies have standards of care for laboratory animals, all of which contain provisions for the careful regulation and monitoring of environmental conditions.
We created these helpful guidelines with detailed information to help both new and experienced companies better understand the regulatory requirements of owning and operating a vivarium. Several include references from the AAALAC (the key national accreditation body promoting the responsible use of animals in science) in their accreditation requirements. Of course, to demonstrate compliance with any of these standards, any animal facility needs not only to adhere to the environmental requirements and ensure that appropriate personnel would know if there are environmental parameter excursions, but also be able to prove it in an inspection.
- Institute for Laboratory Animal Research
Source: https://grants.nih.gov/grants/olaw/guide-for-the-care-and-use-of-laboratory-animals.pdf
Key Takeaways:
- American Society of Animal Science
Source: https://www.asas.org/docs/default-source/default-document-library/agguide_4th.pdf?sfvrsn=56b44ed1_2
Key Takeaways:
-Appendix A of the European Convention for the Protection of Vertebrate Animals Used for Experimental and Other Scientific Purposes (ETS No. 123)
Source: https://www.aaalac.org/pub/E900C0A9-EEB3-1C2E-6A3C-0C84FF348CDD
Key Takeaways:
- United States Department of Agriculture
Source: https://www.aphis.usda.gov/animal_welfare/downloads/bluebook-ac-awa.pdf
Key Takeaways:
These guides are meant to provide a basic understanding of regulatory compliance standards as an organization adopts them in its SOPs. If your company is looking for a better way to monitor a vivarium while staying within the means of regulatory compliance like those described above, XiltriX offers a powerful vivarium monitoring solution. By taking a consultative approach and going beyond basic safeguards, XiltriX provides the software and hardware to measure data, enabling precise experiment replication and maintaining compliance throughout the entire process. With a commitment to continuous monitoring and measuring of environmental data, XiltriX empowers clients to substantiate outcomes, provide essential data for quality control, and comply with local and facility compliance regulations. By adopting these standards, validating the system's integrity, and adhering to accreditation requirements, XiltriX offers a trusted and FDA 21 CFR Part 11-compliant environmental monitoring system that keeps a pulse on your operations. Find out more: