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SmartGene Apps & Lab Accreditation

Laboratory Accreditation: Ensuring Quality and Competence in Testing

Dr Coralie Kerestedjan-Pallier, Hospital Practicioner in France, who recently achieved COFRAC accreditation, attests to the effectiveness of our solution and the value of SmartGene's Customer Support Team in providing assistance and documentation for the SmartGene Apps during their recent accreditation process:

FR: "SmartGene a accompagné très efficacement le service de virologie – LBM Sud, GHU AP-HP, Université Paris Saclay dans la démarche d’accréditation COFRAC selon la norme ISO 15189 version 2022, permettant l’extension de notre accréditation en portée VB04 qui correspond à la virologie spécialisée.  SmartGene nous a fourni tous les éléments nécessaires pour répondre aux exigences de la norme dans la rédaction de notre dossier de vérification de méthode pour le sous-processus concernant l’analyse bio-informatique de nos données de NGS pour le test génotypique de résistance du VIH-1 aux antirétroviraux." Dr Coralie Kerestedjan-Pallier, APHP Hôpital Paul-Brousse (Villejuif, France)

EN: "SmartGene very effectively assisted the virology department – LBM Sud, GHU AP-HP, Université Paris Saclay in the COFRAC accreditation process according to the ISO 15189:2022 standard, allowing the extension of our accreditation in scope VB04, corresponding to specialized virology. SmartGene provided us with all the necessary elements to meet the standard's requirements in the preparation of our method verification file for the sub-process concerning the bioinformatics analysis of our NGS data for the genotypic resistance test of HIV-1 to antiretrovirals." Dr Coralie Kerestedjan-Pallier, APHP Hôpital Paul-Brousse (Villejuif, France)

Accreditation is a vital process for laboratories worldwide, ensuring that they meet the highest standards of quality and competence in testing. In France, the Comité Français d'Accréditation (COFRAC) is the primary body responsible for granting accreditation. COFRAC accreditation signifies that a laboratory adheres to rigorous standards, providing reliable and accurate test results.

The accreditation process involves a thorough evaluation of a laboratory's quality management system, technical competence, and overall operations. Laboratories must demonstrate adherence to ISO/IEC 15189, the international standard for testing and calibration laboratories. This involves extensive documentation, internal audits, proficiency testing, and regular assessments by COFRAC.

When accreditation documentation is needed for a particular SmartGene App, the SmartGene Customer Service Team can provide the necessary guidance and details to meet the requirements. SmartGene Apps are fully compatible with the requirements set forth by COFRAC and other accrediting bodies. Our Customer Support team is well-equipped to assist our customers with relevant documentation, thus ensuring a smooth and efficient path to accreditation.

Dr. Pallier's success is just one example of the compatibility of SmartGene's SaaS solutions with regulatory requirements, and how the SmartGene Customer Service Team has been responsive and informative to help laboratories achieve their accreditation goals, ensuring that they meet high standards of quality and reliability.

NB: Many of the SmartGene Apps are CE-IVD labeled, 21 CFR Part 11 compliant, and documented following CSV guidelines for Medical Device Software.   All of SmartGene's offerings are ISO27001 and HDS / HDH certified.

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