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.

in vitro

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

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

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.

17 de March de 2020

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 […]
10 de January de 2020

Controllab Collaborating Supplier Program Includes Biocon Urine Analyzes

Partnership offers quality assurance, more interaction and knowledge exchange As part of its proposal to offer tools for the constant improvement of laboratory results and in […]
15 de March de 2019

One more supplier is part of the Controllab Collaborating Supplier Program.

A Controllab, em sua busca contínua de disseminar a qualidade nos laboratórios, disponibiliza aos fornecedores de reagentes e equipamentos a participação no Programa Fornecedor Colaborador, com o […]

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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.

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.

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 - Control Laboratory

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.

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