Suppliers of <i>in vitro</i> diagnostic productsSuppliers of <i>in vitro</i> diagnostic productsSuppliers of <i>in vitro</i> diagnostic productsSuppliers of <i>in vitro</i> diagnostic products
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            Suppliers of in vitro diagnostic products

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            • Suppliers of in vitro diagnostic products

            Partnerships between Controllab and suppliers of in vitro diagnostic products offer quality assurance, more interaction and knowledge exchange. ​

            Controllab, in its continuous search to disseminate the quality of the results of the exams, provides diagnostic suppliers with solutions that promote the quality of their products. Among them, participation in programs that provide continuous improvement of laboratory results and in vitro diagnostic products.

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            Suppliers: know the solutions that help
            evidence the performance of your products

            Participating Supplier Partnership
            Contributor Supplier Partnership
            Participating Supplier Partnership

            The Participating Supplier Partnership has the immediate benefit of becoming familiar with Controllab services and accessing general reports on the performance of analytical systems. The supplier participates in the quality control programs and acquires knowledge that allows him to better support his customers in doubts and questions related to the Proficiency Testing, Internal Control and product behavior.

            Contributor Supplier Partnership

            As a Contributor Supplier, the contracting company makes its products available* (reagent, kit, equipment, consumable material) for Controllab to perform the sequence of repeated analyses for internal control valuation. In other words, the reference values for the supplier’s material become part of the package insert for Controllab’s internal control programs, without depending on a minimum training of results of the laboratories that use the system of this supplier.

            Controllab also checks proficiency testing materials with the analytical system of the Collaborating Supplier. This partnership is continuous, with each new control material produced, whether for use in external control or internal control, analyzes and evaluations will be carried out in the supplier’s system. This partnership allows for even more integration between the supplier, the client laboratory and Controllab, as the dynamics of the program favor the exchange of information.

            As the Collaborating Supplier is also a user of the internal and external control programs, having this support is yet another evidence of the company’s commitment to the quality of the products offered. Consequently, there is more reliability for laboratories looking for quality verification when choosing a kit, for example.

            * The availability of products must include reagents, equipment, consumables, installation, training, preventive and corrective technical assistance and any other necessary resources for the tests.

            Linearity Check and Calibration

            In this program, test items produced with a rigorous serial dilution are sent, in order to cover a larger range of concentrations. After analyzing and sending the results, Controllab performs the verification (by interlaboratory comparison or internally) of the analytical system’s ability to reproduce results linearly according to its specification.

            Batch-to-batch validation / Shipping

            Checks the proximity of results obtained with the new batch and the current batch to detect any significant deviations in the performance of the reagent and, then, define whether there is a need for a replacement of the reagent batch.

            Performance Panel

            Used to evaluate and validate new test methods and equipment, the service demonstrates the reliability of the systems. Composed of positive and negative items, with varied concentrations and heterologous items obtained from different donors in the regions of Brazil, this panel is previously valued by different analysis methodologies. The use of low reactive control materials allows obtaining valuable information regarding analytical capacity and variations between reagent lots.

            Development of customized internal control for analytical systems

            Internal control is a tool that enables greater reliability and accuracy of results. The absence of reference values for an analytical system may represent an obstacle for suppliers to enter the market. Controllab has extensive technology and productive capacity in the development of customized controls for the various analytical systems available on the market. In this way, the manufacturer has the opportunity to have a specific quality control material to offer along with his system.

            More solutions that cater to service providers
            in vitro diagnostic products

            Além das soluções descritas, os In addition to the solutions described, suppliers can benefit from services that add more reliability and precision to their processes. See the options available for Certified Reference Materials and Instrument Calibration.

            Materiais de Referência Certificados (MRC)

            It adds more precision and traceability to the analytical process.

            Calibration of Instruments (CA)

            Prevents measurement errors in analysis.

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            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.
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            Collaborating Supplier Program Partners

            Many companies are part of the Contributor Supplier partnership to demonstrate and to ensure the quality of their products. See related benefits for some benefits obtained by these companies.

            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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            December 13, 2021
            Foco Vet
            December 13, 2021
            Categories
            • Uncategorized
            • News
            • Others
            • Supplier of Products
            • Veterinary
            • Veterinary

            Foco Vet joins partnership as Controllab Collaborating Supplier

            The equipment distributor has teamed up with the quality control provider to evidence and ensure the quality of the “BC 30 vet”, a high-tech four-part hematology […]
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            March 17, 2020
            lumiradx
            March 17, 2020
            Categories
            • News
            • Supplier of Products

            LumiraDX: more quality, safety and performance with the Collaborating Supplier Program of Controllab

            English multinational, focused on the Point of Care Testing segment, highlights search for process improvements by including its remote laboratory tests in this partnership. A demanda […]
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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 Inmetro’s General Coordination for Accreditation (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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                      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 Inmetro’s General Coordination for Accreditation (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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                      Cgcre is signatory to the Mutual Recognition Arrangements of the International Laboratory Accreditation Cooperation (ILAC) and Interamerican Accreditation Cooperation (IAAC).

                      PEP 0003

                      Accreditation Cgcre/Inmetro - Proficiency Test Provider

                      In September 2011, Controllab was accredited by Inmetro’s General Coordination for Accreditation (CGCRE) as a proficiency test provider, under nº PEP0003. Initially as part of a pilot project by Inmetro, this accreditation was based on ILAC G13: 2007 and included several clinical and hemotherapy tests. In the periodic evaluations of this accreditation, new segments and tests are included and the evaluation is now conducted according to ABNT NBR ISO/IEC 17043.

                      This accreditation attests to Controllab’s technical competence to develop and conduct proficiency tests in accordance with international requirements and enables it to be recognized in other countries, in accordance with mutual recognition agreements signed by Brazil in Mercosur, the Americas and Europe.

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                      Cgcre is signatory to the Mutual Recognition Arrangements of the International Laboratory Accreditation Cooperation (ILAC) and Interamerican Accreditation Cooperation (IAAC).