Validation and GxP

What regulated customers can rely on

The Controlant platform is validated to comply with FDA 21 CFR Part 11 and EU GMP Annex 11.

GxP compliance belongs to you as the regulated company; what a supplier provides is a validated system that supports it.

• ISO 9001:2015 quality management. BSI certificate FM 669608, valid to 18 October 2029.
• ISO/IEC 27001:2022 information security management. BSI certificate IS 725438, valid to 30 August 2029.
• SOC 2 Type 2, audited annually.

Both certificates are scoped to the design, development, manufacturing and service of supply chain monitoring solutions for pharmaceutical industries.

The validation documentation, and how to ask for it

Controlant's supply chain monitoring platform and devices are fully tested and come with all necessary validation documentation, and are designed to be compliant for use in the pharma supply chain.

Request it through commercial@controlant.com, naming the platform components and device models in scope.

What stays with you

Your own validation and qualification processes govern how Controlant products may be used in a GxP environment: the SOPs your team works to, the qualification of your lanes and packaging, and the acceptance criteria you release product against.

Controlant's professional services can assist with change control and implementation, SOP development, temperature studies, and packaging and lane validation. The decisions and the records stay with you.

User access governance is yours as well. An administrator grants access per user or per role, over shipments, locations and templates, with read, create, modify, approve and delete rights.

Calibration and traceability

Saga devices are calibrated at fixed points against a NIST traceable standard. The points, the accuracy at each and the long-term drift are published per model on the device pages.

Calibration certificates are accessible in the platform for every device on the customer account: each device's last calibration date links to its certificate.

Release notifications

Release notes for the platform, devices, analytics, API, Share and Go are published in the Support Center for each version release, including the live release date and the customer impact.

Audit trail and data integrity

Every system action is recorded in an audit trail, including the platform's own automatic actions. An administrator can trace actions by user and by resource; other users see their own.