A Focus on Quality – Fully Integrated Certificate Management
As products generally consist of a variety of individual constituents – which are often provided by external suppliers – aspects relating to the quality and safety of the final product are decided via the careful selection and control of each base constituent at a very early stage of the production process.
It is therefore of paramount importance, that the origin and quality of each component is documented correctly and that it can be traced all the way back to the individual batch it originated from. This documentation generally consists of inspection reports or certificates. Most products consist of a vast number of constituents or components and the correct management of certificates and inspection reports is subject to strict national and international rules and regulations.
Fully Integrated Certificate Manager
The solution for a clearly structured and compliant management of certificates lies in the application of aggregated certificates, which consist of the individual certificates of each component and are automatically maintained throughout the entire product lifecycle. The comprehensive and fully integrated certificate generator and the inclusion of raw material and supplier certificates in CAQ.Net® allow you to achieve precisely that. By consolidating a vast variety of certificates via article and batch information, one aggregated certificate is formulated that can be easily distributed alongside the final product.
Certificates of Analysis
Particularly strict regulations apply in the chemical and pharmaceutical industries as well as in all other areas in which the final product is consumed directly and people’s health and lives depend on it being free of any impurities or other faults. These regulations therefore primarily address aspects such as audits, certificates, and the overall effectiveness of the quality management system. In the pharmaceutical industry and in areas where critical foodstuffs such as baby food are produced, so-called certificates of analysis (CoA) are applied in order to provide evidence regarding the chemical composition and purity of a product. These certificates prove that the content of substance-batches corresponds to the guidelines of pertinent medical standards or similar validated test methods. The analyses that are applied address a variety of characteristics such as e.g. the pH-value, the percentage of water contained, the microbiological status, or provide evidence that the correct storage temperature was consistently maintained. All of this information needs to be recorded and suitable documentation must accompany each constituent throughout the entire production workflow.
Traceability and GMP
In order to facilitate comprehensive traceability, it is necessary that the certificates of analysis and the corresponding sample protocol are always linked and handled as one unit. It is equally important that the certificates of the individual constituents can always be clearly linked to the final product. CAQ.Net® facilitates this by implementing aggregated certificates and thus supports the implementation of GMP throughout the entire product lifecycle.
Comprehensive Certificate Management
CAQ.Net® provides a whole host of further certificate management functions besides the certificate generator. Far-reaching document management functions, for instance, facilitate the active control, maintenance, and archiving of all certificates and the system-wide change control furthermore ensures that all certificates remain up to date. Employees can then be trained regarding new certificates or process changes via the training management module. CAQ.Net® also provides additional audit and checklist functions as well as action management and escalation procedures in order to always ensure full control of certificates and enable a comprehensive, system-wide certificate overview.
Key Components for the Application in Laboratories
The CAQ.Net® LIMS-Edition equips you with everything that is required for sophisticated quality control and data management in the laboratory. By combining individual LIMS functions such as the certificate manager with all the functions of a comprehensive and cutting-edge CAQ-system, we were able to forge a quality management solution for the pharmaceutical/chemical industry and foodstuffs sector that is second to none. It provides everything that is required for measurement value acquisition and evaluation, audit management, compliance, CRM, gauge management, and much more. The successful application of the CAQ.Net® LIMS-Edition by a number of highly renowned laboratories in a number of industries proves that the combination of a CAQ-system and LIMS functions brings together the best of both worlds for the benefit of product safety and overall production quality.