Compliance by design, from the first prototype
Our lab devices are built for regulated QC and R&D labs. We design the technical controls and documentation that support data integrity and instrument qualification into the hardware and software.
Built around ALCOA+ principles
Records that are attributable, legible, contemporaneous, original and accurate, as well as complete, consistent, enduring and available.
Documentation that supports your validation
Provided with your order.
IQ/OQ documentation
Installation and operational qualification documentation for instrument qualification per USP <1058>.
Calibration certificates
Each device ships with a calibration certificate.
Part 11 assessment
A 21 CFR Part 11 assessment of our software controls, to support your own validation.
GAMP 5-aligned software lifecycle
Software is developed and documented in line with GAMP 5 principles.
How this applies to our products: the Acculize BET 96 Plus is designed for use in 21 CFR Part 11-regulated environments, the Acculize BET 96 Smart provides printed dot-matrix records for standalone use, and both are dry bath heating blocks for the LAL test.
Regulatory compliance depends on the user's validated system and procedures; Acculize lab devices provide the technical controls and documentation to support it.