QUALITY MANAGEMENT AT GATC BIOTECH
GATC Biotech means sequencing with Europe’s leading service provider!
GATC Biotech’s customers can rely on the highest quality data and service standards for their research projects. Our quality standard has been acknowledged by several independent bodies, such as the German Accreditation Body (DAkkS; Deutsche Akkreditierungsstelle GmbH). The permanently updated and validated processes undergo regular internal and external audits for recertification.
As a certified service provider, our scientific methods and data quality are fully compliant with the latest state-of-the-art standards. Fully automated LIMS-controlled processing pipelines guarantee efficient project completion and fast turnaround times.
GATC Biotech places great emphasis on a high level of transparency in all of our processes and we guarantee a reliable and the consistently high quality of our analysis services.
Well-established quality management procedures assure superior quality
Quality Assurance comprises
- Validated processes and equipment used by highly professional scientists
- Extended staff qualification programs
- Optimised workflows supported by our proprietary laboratory information system (LIMS)
- Several quality control steps within the analysis process
- Failure management and a process for corrective action and preventive action (CAPA process)
- Regular participation in proficiency testing
- Internal and external audits for the utmost in objectivity
- Highly automated processes for barcoded samples, keeping errors to a minimum
- Detailed lab reports upon request
- Implemented change process
- Committed data safety and IT security measures
Several external certifications attest to our high standards of quality
The company has been ISO 9001 certified since 1999—evidence that our QM system is highly developed and that we have experience meeting customer needs and expectations.
Your benefits with ISO 9001 certified products and services
- Short production times thanks to highly optimised structured processes
- Well-trained, highly qualified personnel
- Fully documented processes
- Effective complaint and CAPA management
In 2012, the next-generation sequencing laboratories of GATC Biotech’s Genome and Diagnostics Centre became the first in Europe to be accredited by Germany’s accreditation body, DAkkS. Our next-generation sequencing production based on Illumina HiSeq, Illumina MiSeq and PacBio RS II was officially accredited according to the international norm ISO 17025.
The GATC Biotech’s Genome and Diagnostics Centre meets all essential regulatory standards for analysis and calibration laboratories. These include DIN EN ISO/IEC 17025 and DIN EN ISO 9001. Strict observance of these standards is monitored by DAkkS.
The European Custom Sequencing Centre in Cologne has been accredited since 2015.
German accreditation is internationally accepted by the International Laboratory Accreditation Cooperation (ILAC).
ISO 17025 specifications
|Management requirements|| Documented quality management system |
Regular internal audits for continuous improvement
Proprietary Laboratory Information Management System (LIMS)
|Technical requirements|| Validation of analysis methods Participation in inter laboratory comparisons |
Regular testing and calibration of systems
Continuous quality control of reagents and materials
|Customer communication|| Documented customer communication processes (CRM) |
Qualified and trained scientific and technical staff
Detailed, clear, and comprehensible reports of results
Your benefits with ISO 17025 accredited testing
- Guaranteed confidentiality and integrity of testing data
- ISO 17025 accredited testing results are recognised by authorities, customs etc. for release of pharmaceuticals, food and feed and in the case of legal implications
We have been certified to develop in vitro diagnostic medical devices and provide nucleic data analysis for human diagnostics since 2015.
Upon request, we deliver sequencing analysis data meeting GLP/GCP/GCLP/cGMP requirements.
Certified Service Provider status
As an Illumina and PacBio Certified Service Provider, GATC Biotech ensures that our scientific methods and data quality are fully compliant with latest state-of-the-art standards.
We are committed to providing high-quality data from nucleic acid analyses both within the framework of our own services and as a contribution to enhancing international quality standards and sharing experience among international partners. We do this in the following ways:
- By participating in initial projects for developing external quality assessments (EQA). More detailed information is available from the homepage of the European Molecular Quality Network (EMQN), Manchester.
- By taking part in standardisation organisations (DIN and ISO) and projects.
- By providing consulting services and contributing our knowledge in international research projects
Our goal is to maximise customer satisfaction.
GATC Biotech has more than 25 years of experience as a sequencing service provider utilising optimised protocols, cutting-edge technologies and strict quality assurance. Fully automated processing pipelines and certified processes guarantee reliable results and offer customers the most efficient strategy for their scientific approach.
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