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            In Vitro Diagnostic

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            Solutions that enhance the quality of diagnostic analytical systems

            Trust and credibility to monitor your products, capture market share, and strengthen your brand.

            Batch-to-Batch Certification Program

            Each validated batch ensures consistent kits and reliable tests.

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            Collaborating Supplier

            Ensures reference values for your analytical system in Controllab’s Internal Controls.

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            Performance Dashboard

            Tests methods and equipment, ensuring reliability and quality in testing.

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            Linearity Check

            Confirms that your analytical system delivers linear and reliable results across the entire measurement range.

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            Customized Internal Quality Control for Analytical Systems

            Develops customized internal controls to ensure accuracy, reliability, and support for market entry.

            Learn more

            Trust Controllab to accelerate your market entry and strengthen your brand through reliable data, transparency, and a competitive advantage.

            Gain the trust of healthcare services from the very first contact.

            Use market-recognized services and solutions that prove your product’s performance.

            In addition to the solutions described, suppliers can benefit from services that add greater reliability and precision to their processes.
            Explore the available options for Certified Reference Materials.

            Materiais de Referência Certificados (MRC)

            Traceability and accuracy aligned with international standards.

            HAVE AN ENVIRONMENT WITH ANALYSIS OF EXCELLENCE

            Controllab offers complete solutions for quality and assertiveness of results. These solutions facilitate recognition for accreditation processes and regulatory bodies.

            Institutional Brochure

            Partners of the Supplier Collaborator Program

            Many companies join the Supplier Collaborator partnership to demonstrate and ensure the quality of their products.
            Check the related news to see the benefits these companies have gained.

            October 23, 2023
            October 23, 2023
            Categories
            • Supplier of Products

            LabPoc garante valores de referência para dispositivos ao selar parceria com a Controllab

            Iniciativa entre as empresas proporciona mais segurança às rotinas analíticas e evidencia compromisso com a qualidade dos equipamentos. O LabPoc agora faz parte do programa Fornecedor […]
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            March 6, 2023
            March 6, 2023
            Categories
            • Fornecedores de Produtos
            • Supplier of Products

            FirstLab sela parceria com a Controllab e garante valores de referência para tiras de urina

            Iniciativa entre as empresas proporciona mais segurança para as rotinas analíticas. O programa Fornecedor Colaborador da Controllab conta com a adesão da FirstLab. É uma parceria […]
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            February 21, 2022
            Erba
            February 21, 2022
            Categories
            • Quality Control
            • Supplier of Products

            Erba Mannheim integrates Controllab’s supplier program

            Company that works with hematological systems closes a partnership to ensure the reference values ​​of Erba H560 and Elite 580 equipment Erba Mannheim is another partner […]
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                      Fornecedor Colaborador

                      Essa iniciativa garante valores de referência confiáveis para os materiais de Controle Interno (CI) dos sistemas analíticos parceiros usados nos serviços que realizam exames.

                      Funciona assim: o fabricante ou distribuidor estabelece uma parceria contínua com a Controllab e disponibiliza seus sistemas (equipamentos, reagentes e/ou insumos) no laboratório de análises da Controllab. A partir disso, é realizada uma sequência de análises técnicas e estatísticas.

                      Com os resultados obtidos:
                      • São definidos valores de referência específicos para o sistema avaliado.
                      • Esses valores são incluídos nas bulas dos programas de Controle Interno.
                      • O sistema também passa a ser acompanhado nos programas de Ensaio de Proficiência.

                      Esse processo fortalece a confiabilidade, rastreabilidade e comparabilidade dos resultados nos serviços de saúde, contribuindo para decisões clínicas mais seguras.

                      Painel de Perfomance

                      Esse painel ajuda quem realiza exames a testar e validar novos métodos de análise e equipamentos, avaliando a confiabilidade dos sistemas utilizados.

                      Ele é composto por amostras com diferentes níveis de concentração — positivas, negativas e itens heterólogos — coletadas de diversos doadores de várias regiões do Brasil. Essas amostras são previamente avaliadas por diferentes metodologias analíticas.

                      O painel inclui amostras de controle pouco reativas, o que permite obter informações valiosas sobre a capacidade analítica do método e identificar variações entre lotes de reagentes. Isso oferece segurança para que o serviço de saúde confie na eficácia dos seus métodos e equipamentos, assegurando a qualidade dos resultados.

                      Verificação da Linearidade

                      Este serviço utiliza um conjunto de amostras com diluições seriadas, preparadas de forma rigorosa para cobrir uma ampla faixa de concentrações. O objetivo é verificar se o sistema analítico mede essas concentrações de forma linear, ou seja, se os resultados acompanham proporcionalmente a variação real dentro da faixa especificada pelo fabricante do método ou equipamento.

                      Após a análise e o envio dos resultados, a Controllab verifica a linearidade, confirmando se o sistema é capaz de reproduzir resultados de forma linear conforme sua especificação.

                      Essa verificação é essencial para assegurar o bom desempenho do método analítico e garantir a confiabilidade dos resultados em toda a faixa de medição.

                      Controle Interno Customizado para Sistemas Analíticos

                      O Controle Interno monitora continuamente a qualidade dos exames. Sem valores de referência específicos, sistemas analíticos podem ter dificuldades para entrar no mercado.

                      A Controllab desenvolve controles internos customizados, garantindo:
                      • Maior confiabilidade dos resultados.
                      • Diferencial competitivo para o fabricante.
                      • Oferta de solução completa para quem realiza o exame.

                      Com expertise técnica e estrutura dedicada, a Controllab cria controles que atendem às características específicas do seu sistema, assegurando desempenho e segurança nos exames.

                      Collaborating Supplier

                      This initiative ensures reliable reference values for Internal Control (IC) materials of partner analytical systems used by testing services.

                      Here’s how it works: the manufacturer or distributor establishes an ongoing partnership with Controllab and makes its systems (equipment, reagents, and/or supplies) available at Controllab’s analysis laboratory. From there, a series of technical and statistical analyses are carried out.

                      Based on the results obtained:
                      • Specific reference values are defined for the evaluated system
                      • These values are included in the package inserts of the Internal Control programs.
                      • The system is also monitored in Proficiency Testing programs.

                      This process strengthens the reliability, traceability, and comparability of results in healthcare services, contributing to safer clinical decisions.

                      Performance Dashboard

                      This panel helps those who perform exams to test and validate new analytical methods and equipment by assessing the reliability of the systems used.

                      It consists of samples with different concentration levels — positive, negative, and heterologous items — collected from various donors across different regions of Brazil.
                      These samples are pre-assessed using different analytical methodologies.

                      The panel includes low-reactivity control samples, which provide valuable information about the analytical capacity of the method and help identify variations between reagent batches. This offers safety for healthcare services to trust the effectiveness of their methods and equipment, ensuring result quality.

                      Linearity Check

                      This service uses a set of samples with serial dilutions, rigorously prepared to cover a wide range of concentrations. The goal is to verify whether the analytical system measures these concentrations linearly, that is, if the results proportionally follow the real variation within the range specified by the method or equipment manufacturer.

                      After analysis and result submission, Controllab checks the linearity, confirming whether the system can reproduce results linearly according to its specifications.

                      This verification is essential to ensure the good performance of the analytical method and guarantee the reliability of results throughout the measurement range.

                      Customized Internal Quality Control for Analytical Systems

                      Internal Control continuously monitors test quality. Without specific reference values, analytical systems may face difficulties entering the market.

                      Controllab develops customized internal controls, ensuring:
                      • Greater reliability of results.
                      • Competitive advantage for the manufacturer.
                      • A complete solution offering for testing laboratories.
                      With technical expertise and dedicated infrastructure, Controllab creates controls tailored to the specific characteristics of your system, ensuring performance and safety in testing.
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                      PRM 0009

                      Accreditation Cgcre/Inmetro - Certified Reference Material Producer

                      Controllab has been accredited as a Certified Reference Material Producer (MRC) since 2016 by Coordenação-Geral de Acreditação do Inmetro (CGCRE), under the PMR 0009 number. The assessment of this conformity is carried out according to the requirements established in ABNT NBR standards ISO 17034 and Inmetro, thus ensuring competence for the production of MRCs, according to the Scope of Accreditation.

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                      access accredited scope
                      Materiais de Referência Certificados - PMR 0009 - ABNT NBR ISO 17034-Controllab
                      Cgcre is signatory to the Mutual Recognition Arrangements of the International Laboratory Accreditation Cooperation (ILAC) and Interamerican Accreditation Cooperation (IAAC).

                      CAL 0214

                      Accreditation Cgcre/Inmetro - Calibration Laboratory

                      In December 2002, the Calibration Laboratory was accredited by Coordenação-Geral de Acreditação do Inmetro (CGCRE). With this recognition, it became an integral part of the Brazilian network of accredited laboratories, under nº214. Since then, it is periodically evaluated for the maintenance and/or extension of accreditation.

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                      access accredited scope - RBC/Cgcre/Inmetro - Physical-Chemical
                      access accredited scope - RBC/Cgcre/Inmetro - Massa
                      access accredited scope - RBC/Cgcre/Inmetro - Volume and Specific Mass
                      access accredited scope - RBC/Cgcre/Inmetro - Pressure
                      access accredited scope - RBC/Cgcre/Inmetro - Temperature
                      Calibração de Instrumentos - CAL 0214 - ABNT NBR ISO/IEC 17025 - Controllab
                      Cgcre is signatory to the Mutual Recognition Arrangements of the International Laboratory Accreditation Cooperation (ILAC) and Interamerican Accreditation Cooperation (IAAC).