A Trusted Partner for Comprehensive Instrument Calibration

In the captivating world of genomic exploration, where the intricacies of life's code are deciphered and the frontiers of scientific knowledge are pushed ever further, one company stands at the forefront: Illumina. Known for its visionary genome-sequencing devices, Illumina has long understood that the pursuit of groundbreaking discoveries demands accuracy and precision. To that end, the company has embarked on a partnership with Tektronix, the experts in test and measurement equipment, to manage the calibration of the company’s wide array of instruments.

A large manufacturer in an FDA regulated industry found itself with repeated Form 483 findings. Tektronix partnered with the company to determine the right type of calibration services.

The US Food and Drug Administration (FDA) consistently lists inadequate maintenance and calibration procedures as a top reason for issuing Form 483 observations to medical device manufacturers (hint: this is NOT a good thing). Within highly regulated industries, calibration program problems can leave you open to risks ranging from delays in time to market to increased liability and patient safety.

The regular calibration of sensitive medical equipment test instrumentation such as temperature sensors, pressure transducers and weighing instruments is mandated by the U.S. Food and Drug Administration (FDA). Precise and repeatable measurements are crucial for test equipment being used in the medical equipment given the increased risk associated with non-compliance for medical device manufacturers. 

Calibration management systems that provide real-time visibility and consistency should be standard operating procedure for companies in regulated industries. Using a manual or hybrid process for calibration management can lead to missed calibration cycles. Instruments that are left uncalibrated can offer less accurate data, resulting in compromised product quality and downtime.

Learn about the differences between a traditional CMMS and web-based calibration program management, and find out how you can take your calibration program to the next level with CalWeb.