Full GMP compliance including electronic signatures

(Bonaduz, 1/17/2019) – Hamilton Bonaduz AG recently released the next generation of its ArcAir sensor management software, adding features that further streamline processes for biopharmaceutical companies looking for more robust GMP compliance.

First launched in 2016, ArcAir allows technicians to manage and monitor process sensors across a production plant. Instead of a manual process that required at-line calibration and printed documentation, ArcAir enables a process where pH, ORP, dissolved oxygen and conductivity sensors are calibrated in a controlled lab setting and then deployed to the production environment. These sensors can then be monitored remotely via a smartphone, a tablet or directly on a PCS/Computer.

This latest ArcAir release adds a handful of features that will help companies increase their GMP capabilities:

  • Sensor calibration and validation reports can be electronically signed, allowing for a completely paperless workflow. This adds to the existing functionality where process technicians can calibrate, document, and review all sensor history from a digital interface and quickly produce GMP compatible documentation.
  • In addition to automated reporting and centralized data storage, all activities from Windows, Android and iOs devices are now logged in an audit trail. This enables full traceability of user actions, allowing for compliance with international GMP regulatory guidances.
  • Users can be assigned to user groups and roles with pre-defined access rights, in compliance with individual internal user rules. Customized user roles can be created according to customer needs, too.
  • Finally, the ArcAir IQ/OQ service in combination with the regulatory compliance documentation updates now supports faster on premise validation.

Each of these new features adds to the already robust feature set which boasts responsive design, barcode/ QR code scanning of calibration buffers and the step-by-step instructions for calibration and verification.

All features are included in the ArcAir Advanced version, and ready for compliance with the requirements of GMP guidances such as FDA CFR 21 Part 11 and EudraLex Volume 4 Annex 11.

All mobile versions of ArcAir can be downloaded from Apple’s App Store, Google’s Play Store and the Amazon Appstore for territories (such as China) where the before mentioned stores are not available. The desktop version of the software is available at www.hamiltoncompany.com/arcair.