Quality and Information Security Policy
Dreamgenics is a Spanish biotechnology company formed by a multidisciplinary team of computer scientists, bioinformaticians, clinicians and geneticists with extensive experience in different omics and bioinformatics technologies. As a fundamental part of our activity in the field of bioinformatics is the development of products and services to carry out the analysis and interpretation of genomic data from next generation sequencing (NGS) technologies. Our products include the NGS data analysis software Genome One. This software, as well as all the analyses performed with it, comply with the necessary requirements regarding the CE marking of medical devices for in vitro diagnostics (IVD) in accordance with current legislation.
Our day-to-day work includes the performance of genomic studies (genomes, exomes, targeted exomes, etc.), including data analysis and clinical interpretation of the variants found. We also carry out transcriptomic and metagenomic data analysis for different diseases, both at clinical and research level.
OUR MISSION
To provide clinicians and researchers with genomic, proteomic and bioinformatics solutions to help decipher the molecular basis of diseases.
OUR VISION
Each of us at Dreamgenics is proud to be able to contribute to the development of Precision Medicine and our desire is to continue improving every day to help improve people's quality of life.
The pillars on which Dreamgenics is based are fundamentally:
- Support to clinicians and research groups.
- Vast experience, soundness and scientific basis, as well as a deep knowledge of the technology market.
- The in vitro diagnostic medical devices and services provided to our customers carry with them quality, clear and fast results that allow a simple and intuitive genome interpretation in a language very close to the clinic and research.
- Compliance with applicable legal and business requirements regarding medical devices, information security and information systems, among others.
- Ensuring the confidentiality, integrity and availability of the information that our stakeholders deposit and that Dreamgenics stores in its information systems.
- The achievement of excellent working conditions and an excellent working environment, which allows for a high level of satisfaction of the multidisciplinary work team that makes up Dreamgenics.
- Improving the quality of healthcare products and services provided by analysing data and identifying areas for improvement, working together with the stakeholders involved.
We pursue a continuous improvement of our processes and the maintenance of a Technological Management System in accordance with the requirements established by the UNE-EN ISO 9001 standard (Quality management systems, requirements), the UNE-EN ISO 13485 standard (Medical devices, Quality management systems, requirements for regulatory purposes) and the UNE-ISO/IEC 27001 standard (Information security management systems, requirements), requirements for regulatory purposes) and the UNE-ISO/IEC 27001 standard (Information security management systems, requirements), the scope of which is defined as "The provision of bioinformatics analysis of data from genomic material sequencing for clinical and research purposes", "The design and development of software for services of bioinformatics analysis of data from sequencing of genomic material" (based on ISO 9001), "The design and development of software for services of bioinformatics analysis of data from sequencing of genomic material for in vitro diagnosis of genetically based human diseases" (based on ISO 13485) and "The information systems that support the services of: - design and development, marketing and maintenance of software and services - provision of bioinformatics analysis services of DNA sequencing data according to the statement of applicability in force at the date of issuance of the certificate" (based on ISO/IEC 27001).
This policy is reviewed at least once a year in order to verify its adequacy to the actual way the Company operates, as well as to the context in which it provides its services, and provides the reference framework for setting quality and information security objectives.
In order to make it known, it is disseminated to staff and publicly displayed on our website.
Edition - 07
Last modified: 18/11/2021
Quality and Information Security Policy
Dreamgenics is a Spanish biotechnology company formed by a multidisciplinary team of computer scientists, bioinformaticians, clinicians and geneticists with extensive experience in different omics and bioinformatics technologies. As a fundamental part of our activity in the field of bioinformatics is the development of products and services to carry out the analysis and interpretation of genomic data from next generation sequencing (NGS) technologies. Our products include the NGS data analysis software Genome One. This software, as well as all the analyses performed with it, comply with the necessary requirements regarding the CE marking of medical devices for in vitro diagnostics (IVD) in accordance with current legislation.
Our day-to-day work includes the performance of genomic studies (genomes, exomes, targeted exomes, etc.), including data analysis and clinical interpretation of the variants found. We also carry out transcriptomic and metagenomic data analysis for different diseases, both at clinical and research level.
OUR MISSION
To provide clinicians and researchers with genomic, proteomic and bioinformatics solutions to help decipher the molecular basis of diseases.
OUR VISION
Each of us at Dreamgenics is proud to be able to contribute to the development of Precision Medicine and our desire is to continue improving every day to help improve people's quality of life.
The pillars on which Dreamgenics is based are fundamentally:
- Support to clinicians and research groups.
- Vast experience, soundness and scientific basis, as well as a deep knowledge of the technology market.
- The in vitro diagnostic medical devices and services provided to our customers carry with them quality, clear and fast results that allow a simple and intuitive genome interpretation in a language very close to the clinic and research.
- Compliance with applicable legal and business requirements regarding medical devices, information security and information systems, among others.
- Ensuring the confidentiality, integrity and availability of the information that our stakeholders deposit and that Dreamgenics stores in its information systems.
- The achievement of excellent working conditions and an excellent working environment, which allows for a high level of satisfaction of the multidisciplinary work team that makes up Dreamgenics.
- Improving the quality of healthcare products and services provided by analysing data and identifying areas for improvement, working together with the stakeholders involved.
We pursue a continuous improvement of our processes and the maintenance of a Technological Management System in accordance with the requirements established by the UNE-EN ISO 9001 standard (Quality management systems, requirements), the UNE-EN ISO 13485 standard (Medical devices, Quality management systems, requirements for regulatory purposes) and the UNE-ISO/IEC 27001 standard (Information security management systems, requirements), requirements for regulatory purposes) and the UNE-ISO/IEC 27001 standard (Information security management systems, requirements), the scope of which is defined as "The provision of bioinformatics analysis of data from genomic material sequencing for clinical and research purposes", "The design and development of software for services of bioinformatics analysis of data from sequencing of genomic material" (based on ISO 9001), "The design and development of software for services of bioinformatics analysis of data from sequencing of genomic material for in vitro diagnosis of genetically based human diseases" (based on ISO 13485) and "The information systems that support the services of: - design and development, marketing and maintenance of software and services - provision of bioinformatics analysis services of DNA sequencing data according to the statement of applicability in force at the date of issuance of the certificate" (based on ISO/IEC 27001).
This policy is reviewed at least once a year in order to verify its adequacy to the actual way the Company operates, as well as to the context in which it provides its services, and provides the reference framework for setting quality and information security objectives.
In order to make it known, it is disseminated to staff and publicly displayed on our website.
Edition - 07
Last modified: 18/11/2021