Quality Commitment

rap.ID’s product quality is directly linked to the company’s strong commitment to highest regulatory standards. rap.ID´s quality policy is to meet or exceed our customers' needs and expectations through continual improvement of our processes, products and services.

Both rap.ID facilities’ in Europe and the US comply with the ISO 9001:2008 standards. The contract testing laboratories provide investigations under GMP and have proven their compliance by the US FDA. The Berlin headquarter passed the January 2015 audit with no ´483´ observation and the Princeton laboratory passed August 2017 with no´483´ observation.

rap.ID laboratories are meeting the requirements of the following quality standards:

  • 21 CFR parts 210 & 211

  • 21 CFR part 820

  • cGMP-compliant

  • FDA Registered & Inspected

    • rap.ID GmbH, January 2015 with no´483´ observation

    • rap.ID Inc., August 2017 with no´483´ observation

  • DEA licensed rap.ID Inc.

  • ISO 9001:2008 rap.ID Inc.

  • ISO 9001:2008 rap.ID GmbH

 

The entire instrumentation software line is 21 CFR Part 11 compliant and can be delivered with (IQ, OQ, and PQ) qualification documentation upon request.

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© rap.ID Particle Systems GmbH