Validation & Compliance

GEX has validated the DoseControl system and the associated instructions for installation and operation in accordance with GEX QMS policies. See Product Development and ISO 9001:2015 compliance.

• Validation documentation is available for audit at GEX offices in Palm City, FL U.S.A. or electronic copies may be purchased.

• Current product specification and usage documents are available in the document library, and maintained in accordance with GEX QMS policies.

Compliance with Industry Guidelines and Standards

• Compliant with ISO 11137, ISO/ASTM 51275, 51261, 51649, 52628 consensus standards.

• Compliant with electronic records requirements of US FDA 21 CFR, Part 11. DoseControl does not have electronic signature functionality.

• An internal GEX assessment has determined that this software and the lifecycle design comply with all applicable sections of EU Annex 11 with regard to electronic records. 

User responsibilities

The end-user must follow and abide by the system security and product documentation for the installation, maintenance, and operation of this product in order to be fully compliant with the above listed guidelines.