FDA Compliance

Validation of your system keeps you in compliance with FDA guidelines, including 21 CFR Part 11. The Validated Datatron EXT Monitoring System meets or exceeds the requirements set by GMP, GLP, AABB, and HACCP for temperature monitoring and electronic record keeping.

Documentation Package

Validation is included as part of a full IQ / OQ / PQ documentation package with the Datatron EXT Environmental Monitoring System installation.

Certified Validation Specialists

Validation is performed by R&D Scientific trained and certified validation specialists.