Validated Conformity
to Standards

„Validation with proof of
capability“ Certificate

Validation with proof of capability

The Society for the Advancement of Quality Management, GFQ Akademie GmbH, presented this certificate to CAQ AG Factory System as the first German software company recipient. This verifies the flawless conformity of our software solutions to pertinent standards, rules and regulations, directives, and recommendations in the area of quality, environmental, and production management.

The Society for the Advancement of Quality Management, GFQ Akademie GmbH, confirmed, by awarding this certificate, all of CAQ AG Factory Systems (its main headquarters and subsidiaries located in Rheinböllen [D], Langgöns [D], Vienna [A], London [GB], and Wilmington [USA]) existing modular software solutions for quality, environmental, and production management. The Society for Advancement of Quality Management, GFQ Akademie GmbH, arrived at its decision to grant CAQ AG Factory Systems this certificate by means of comprehensive audits of products, systems, and procedures, as well as capability tests, product validations, suitability assessments, and product validations during a time span of three months. It also performed detailed tests assessing CAQ AG Factory Systems software’s complete compliance with demands stemming from standards, rules and regulations, directives, and recommendations.

• DDIN EN ISO 9001
• ISO/TS 16949
• IATF HTS 2
• QS 9000
• VDA Vol. 1, Vol. 2, Vol. 3 Part 1+2, Vol. 4, Vol. 4 Chapter 1-9, Vol. 5, Vol. 6, Vol. 6 Part 1+2+3+4+5+7, Vol. 7, Vol. 8, Vol. 9 Vol. 10, Vol. 12, Vol. 13, Vol. 16, Vol. 18, Vol. 18 Part 1+2+3+4+6+7+8
• VDI/VDE 2618
• Six Sigma
• VW 10130, VW 10131, VW 10133
• ISO 5479
• ISO 3951, ISO 3951-1, ISO 3951-2
• ISO 2859, ISO 2859-1, ISO 2859-3
• ISO 3534-2
• ISO 21747
• DIN 32937
• DIN EN ISO 10012
• DIN EN ISO/IEC 17025
• DIN EN 10204
• EFQM
• DIN EN 9100
• ISO 14000
• DIN EN ISO 14971
• DIN EN ISO 13485
• GMP
• FDA 21 CFR Part 11

The software modules’ compliance with regard to content, function, nomenclature, procedures, and methods, as well as all verified calculation procedures of the standards, rules and regulations, directives, and recommendations was deemed flawless within the framework of product, system, and process audits.

CAQ AG Factory Systems also charged the Society for Advancement of Quality Management, GFQ Akademie GmbH, to continually, and without prompting, perform cyclical validations for all updates, upgrades, and new releases, for example perform annual validations. In certain cases, the validation documentation may be viewed after explicit agreement with the client.