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.
Suppliers: know the solutions that help
evidence the performance of your products
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.
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.
It adds more precision and traceability to the analytical process.
Prevents measurement errors in analysis.
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.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.
