Controle Interno (CI)
logo-CI-ONLINE
MORE SAFETY FOR YOUR LABORATORY

Identify and eliminate errors
inherent in the process

The Internal Control (CI) is responsible for the continuous monitoring of the reproducibility of the laboratory analytical phase, identifying and eliminating errors inherent to the process of analysis of quantitative and qualitative tests. Its purpose is to keep the variability of the test analysis process under control and to offer an opportunity to improve the activities developed in the laboratory.

By enrolling in the internal control programs, the participating laboratory will have access to the service via CI ONLINE, a powerful tool for the management of internal quality control, analysis and treatment of deviations related to batch variation, stability of reagents and calibrators, as well as such as the inaccuracy of the analysis process and its performance over time.

Controllab Catalog

Get to know the broad portfolio of tests covered by quality control and sign up to monitor the quality of tests performed in your routine.

Benefits of Controllab’s Internal Control Program

It unifies and monitors all daily activities of internal quality control

Enables the use of Internal Control materials from other suppliers available on the market and developed by the laboratories themselves

Fully automate your routine internal controls with your Laboratory Information System (LIS)

The laboratory can compare its performance, in each routine, with that of other similar laboratories

Most samples are previously valued through the Proficiency Testing or interlaboratory, which gives them an important reference for their valuation process.

Samples produced with the most modern quality standards in Good Manufacturing Practices (GMP), tested and approved in accordance with the requirements of ABNT NBR ISO/IEC 17043 and ISO 13528 for homogeneity and stability carried out in accredited Controllab testing quality control laboratories according to ISO/IEC 17025 (CRL0586)

In order to ensure metrological traceability, allowing instrument calibration and method validation, Controllab uses Certified Reference Materials (CRM) produced by itself with recognition and competence established in ABNT NRB ISO 17034:2017 (PMR 0009)

ACCREDITATIONS AND
RECOGNITIONS

The samples that integrate the Controllab Internal Control Program go through a rigorous production process, homogeneity and stability. This commitment has provided some recognition:

According to the scope
published at www.inmetro.com.br

Analytical Process Control

At CI ONLINE the laboratory can use Controllab samples (valued by interlaboratory), the internal control materials from other suppliers available on the market and those developed by the laboratories themselves with visualization of the behavior of the results in a single Control Center. This flexibility generates more practicality and productivity in the routine analysis and monitoring processes.

beneficio1 prevencao falhas

Facilitates failure prevention and resolution

Issues approvals, alerts and rejections of analytical runs in real time for laboratory tests.

beneficio2 grafico levey jennings

Performance monitoring

Uses Levey Jennings graphics for tests and equipment.

beneficio3 regra controle

Control rules

It allows the choice of control rules (alerts and rejection) that are most appropriate to the routine: multiple Westgard rules, Percentage, DP or Fixed Limit.

beneficio4 resumo

Summary and statistical information

Displays summary and statistical information for monitoring and decision making.

beneficio5 rastrea acoes

Tracks actions completely

It allows the inclusion of actions and comments with access to the documentation: package insert of reagents/kits and control materials; and equipment manuals.

beneficio6 certificacoes

Meets laboratory accreditation standards

ISO 17025, ISO 15189, PALC, ONA, DICQ and others.

beneficio7 comprova

Prove your credibility and quality

The evidence is quick and practical for regulatory bodies, certifiers and accreditors such as INMETRO, ANVISA, VISA e MAPA.

COMPLETE MANAGEMENT OF INTERNAL QUALITY CONTROL AND INTERLABORATORIAL COMPARISON

CI ONLINE + Integration

CI ONLINE works via web on any device, such as computers, tablets and smartphones, allowing the user the mobility to use anywhere with security, confidentiality and scalability.

Another advantage is that it allows the Integration of any Laboratory System, sending the results and receiving the information of approval or not of the analytical run. The use of “CI ONLINE Integration” fully automates the internal quality control from the receipt of samples to the approval of analytical runs, increasing the safety and productivity of your laboratory.

ci content

How CI ONLINE + Integration will make your routine easier

integracao ci etapa1 1
1   Sample

By reading the sample through the Internal Control barcode, your laboratory’s LIS automatically identifies the control.

integracao ci etapa2 1
2   Laboratory LIS

The integration of LIS, Middleware and equipment, speeds up the sending of control data since it does not require typing.

integracao ci etapa3 1
3   Middleware

Through this exchange, all approvals, alerts and rejections are identified and transmitted in real time.

integracao ci etapa4 1
4   Online System

Demonstrates data in real time for any device, allowing agility in the actions of the analytical routine.

CI ONLINE: MONITORING OF THE ANALYTICAL SYSTEM AND ONLINE CONTROL CENTER

Analyze the behavior of your routine data anywhere

How to monitor data monitoring in CI ONLINE?

The control center allows the user to analyze anywhere (inside or outside the laboratory) the behavior of the data in their routines. According to acceptance rules pre-configured by the laboratory, the system issues alerts that signal data outside its specifications.

Actions such as a new valuation period, data deletion/alteration, control rules changes and comments, can be performed in the Data Entry area at any time by the user. All history is recorded to ensure full traceability of your actions.

What resources are used by CI ONLINE to monitor quantitative data?

In CI ONLINE the laboratory defines for each test which control rules should be used. In this process, the laboratory, with its quality specification, must register the reference values ​​and/or the multiple rules necessary to control its routine.

The system also allows the user to follow their data through the Levey-Jennings graph in an interactive way, including actions and comments during the routine, and to view the application of multiple rules.

In addition to the graph monitoring, the user has access to the statistical summary with monthly analysis, accumulated (from all data since the beginning of the use of the control material) and “in use” (data statistics for the configured control rule) and statistics per batch of the reagent kit used.

Vitros® system users also have specific statistics per slide generation. Data is easily viewed and any sudden or gradual change in performance can be identified immediately

How does CI ONLINE contribute to the improvement of the routine?

CI ONLINE has a report that correlates the batch of reagent kits, the period of use and the number of times that it was applied.

It has a resource for identifying recurrent causes, which helps in verifying the effectiveness of the implemented actions. During the analysis of violations of the control rules and/or the Allowed Random Error, if the reported cause has already been used for the same exam/test material, the system will indicate the recurrence(s), equipment/kit/material control/lot(s) and associated reason(s).

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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CRL 0586

Acreditação Cgcre/Inmetro - Laboratório de Controle

Em dezembro de 2012, o Laboratório de Controle, responsável pelas análises de controle de processo e controle de qualidade dos materiais preparados pela Controllab para atender ao Ensaio de Proficiência e Controle Interno foi acreditado pela Coordenação Geral de Acreditação (CGCRE) do Inmetro, tornando-se parte integrante da rede brasileira de laboratórios acreditados, sob o nº 0586.

O selo do Inmetro atesta competência técnica, credibilidade e capacidade operacional da Controllab para a realização de ensaios, conforme requisitos da ABNT NBR ISO/IEC 17025.

A Cgcre é signatária dos Acordos de Reconhecimento Mútuo da International Laboratory Accreditation Cooperation (ILAC) e da Interamerican Accreditation Cooperation (IAAC)

Certificado BPF/ANVISA

Materiais para controle de qualidade

Em outubro de 2012, a Controllab recebeu a certificação de Boas Práticas de Fabricação de produtos para saúde, para as classes de risco I e II, concedida pela Anvisa, e em novembro de 2018 para as classes de risco III e IV, mediante a Resolução RE n.º 4.023, publicada no DOU de 06/10/2020, suplemento, relativa à produção de produtos para saúde para fins de controle de qualidade de laboratórios.

Esse processo de certificação é voluntário e conduzido conforme requisitos da Resolução RDC n.º 16, de 28 de março de 2013 (BPF para produtos para diagnóstico para uso in vitro), frente a qual a Controllab é inspecionada periodicamente (como correlata), pela Vigilância Sanitária para verificação das boas práticas de fabricação.

A ANVISA é uma agência regulamentadora vinculada ao Ministério da Saúde do Brasil, que tem a missão de proteger e promover a saúde, garantindo a segurança sanitária de produtos e serviços. Embora o registro junto a Anvisa não se aplique aos materiais da Controllab (RDC n.º 36/2015, Artigo 2º, Parágrafo Único, I), a certificação em BPF é aberta.

Request Controllab Internal Control and count more safely on the laboratory.

CRL 0586

Accreditation Cgcre/Inmetro - Control Laboratory

In December 2012, the Control Laboratory, responsible for the analysis of process control and quality control of the materials prepared by Controllab to meet the Proficiency Test and Internal Control, was accredited by Inmetro’s General Coordination for Accreditation (CGCRE), becoming if part of the Brazilian network of accredited laboratories, under Nº 0586.

A Cgcre é signatária dos Acordos de Reconhecimento Mútuo da International Laboratory Accreditation Cooperation (ILAC) e da Interamerican Accreditation Cooperation (IAAC)

BPF/ANVISA Certificate

Quality control materials

In October 2012, Controllab received the certification of Good Manufacturing Practices for health products, for risk classes I and II, granted by Anvisa, and in November, 2018 for risk classes III and IV, through Resolution RE n.º 4,023, published in the DOU of 06/10/2020, supplement, related to the production of health products for the purpose of laboratory quality control.

This certification process is voluntary and conducted according to the requirements of Resolution RDC n.º 16, of March 28, 2013 (GMP for diagnostic products for in vitro use), against which Controllab is periodically inspected (as a correlate), by Health Surveillance to verify good manufacturing practices.

ANVISA is a regulatory agency linked to the Ministry of Health of Brazil, whose mission is to protect and promote health, guaranteeing the health safety of products and services. Although registration with Anvisa does not apply to Controllab materials (RDC No. 36/2015, Article 2, Sole Paragraph, I), GMP certification is open.

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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.

A Cgcre é signatária dos Acordos de Reconhecimento Mútuo da International Laboratory Accreditation Cooperation (ILAC) e da 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.

A Cgcre é signatária dos Acordos de Reconhecimento Mútuo da International Laboratory Accreditation Cooperation (ILAC) e da Interamerican Accreditation Cooperation (IAAC)