Quality Born of Passion. Chemicals, Pharmaceuticals, and Foodstuffs. Quality Management Software Solutions

Transcription

1 Quality Born of Passion Chemicals, Pharmaceuticals, and Foodstuffs Quality Management Software Solutions

2 Chemicals, Pharmaceuticals, and Foodstuffs Modular quality management solutions for your industry The origin and quality of every individual constituent is of paramount importance in the chemical, pharmaceutical, and foodstuffs industries. In order to be able to further improve our software s performance in these industries, special functions such as LIMS and certificate management were added to the portfolio of CAQ.Net. Chemicals Almost every line of business at some point relies on the products of the chemical industry. There would most probably be a standstill in the plastics, foodstuffs, automotive, or mechanical engineering industries without the over 70,000 products of the chemical industry. The chemical industry converts raw materials (oil, natural gas, air, water, metals, and minerals) into polymers and plastics, synthetic rubber, surfactants, dyes and pigments, turpentine, resins, carbon black, explosives, and rubber products or inorganic chemicals like salt, chlorine, caustic soda, soda ash, or acids: all of which are key products that consumers and industries alike rely on. As these chemicals also serve as the base constituents for subsequent products in other industries such as consumer goods, agriculture, manufacturing, construction, and the service sector, a consistently reliable level of quality is a factor of special importance in this initial phase of the production chain. DIN EN ISO risk analysis methods (before/after matrix) Production standards Within its regular operations, the chemical industry must adhere to more rules than merely those of the periodic table. The ICS 71 standards catalogue, for instance, sets the guidelines for chemical technology and production in the chemical industry. Safety also plays a major part, as the substances employed are often hazardous to humans and the environment. Hence, the American TSCA or regulations by the EPA and further industrial chemical standards outline strict guidelines for the testing and evaluation of the physical and chemical properties of substances. REACH, CLP, and the Certificate of Analysis (C of A) are further measures that are applied. The qualification matrix allows you to precisely establish which employee requires training in which area CAQ AG Factory Systems

3 One of the most important factors in the chemical industry is, of course, the purity of substances. This can best be ensured by achieving a consistently high level of quality in products and production processes. That is why our solutions provide everything you need in order to be able to manage, improve, and comprehensively document your adherence to standards and quality. Pharmaceuticals The interplay between quality and safety is particularly important in the pharmaceuticals industry, as lives rely directly on the products that are produced. That is why this sector is very closely monitored by various authorities and is subject to strict rules and regulations such as Directive 2001/83/EC of the European Parliament, FDA, or GMP. These ensure that nothing is brought to market that does not comply with pertinent quality and safety measures and that the product, production process, packaging, and shipping are all faultless. Here too the documentation of standards and quality adherence are crucial factors for any company operating in this sector. In order to meet these demands, a vast variety of pharmaceutical companies lay their trust in our quality management solutions. A holistic solution Successful quality assurance and management in the field of chemicals and pharmaceuticals therefore requires an all-inclusive management solution that covers all quality-related facets from product design to complaint management and safeguards consistent compliance and traceability. This solution must also incorporate aspects of LIMS and facilitate the adherence to valid standards and guidelines. This solution is CAQ.Net : your all-inclusive management solution for the chemical and pharmaceuticals sector. Foodstuffs Our everyday food is probably one of the most strictly controlled products in circulation. The International Food Standard (IFS), British Retail Consortium, GMP, HACCP, ISO 22000, or the MSC-Standard are only a few of the rules and regulations that apply in the foodstuffs industry. CAQ.Net therefore offers a whole host of vital functions in order to support our many customers in the foodstuffs industry with regard to the adherence to these regulations. Far-reaching document management functions, for instance, facilitate the active control, maintenance, and archiving of all documents or certificates of analysis. Features Certified compliance with GMP, ISO 9001, and FDA 21 CFR Part 11 Bidirectional integration into a vast variety of IT-systems Laboratory Information System (LIMS) Online/offline audit and checklist management Certificate generator and management of Certificates of Analysis (CoA) Qualification matrix for monitoring employee training measures Graphic evaluation planning with statistic and analysis functions Traceability down to the individual measurement value Inspection plans for incoming goods, SPC, and outgoing goods Integrated supplier management and webbased supplier evaluation functions Systemwide audit-trail SPC with machine and process capabilities (Pm/Pmk, Pp/Ppk, Cp/Cpk) Change management with cross-departmental change workflows Consistent implementation of PDCA and Kaizen in a cross-modular cycle of control Form generator for designing customized forms Escalation management for action and due-date tracking Workflow-management and assessment of action effectiveness Cross-modular linkage of articles, article groups, processes, documents, inspection plans, etc. User-specific access control Sophisticated system-wide document management functions Optimized for usage on touchscreens And much more System-wide change control furthermore ensures that all documents remain up to date. Our training management module monitors employee-training

4 regarding new documents or process changes. CAQ.Net also provides comprehensive audit and checklist functions as well as action management and escalation procedures in order to always ensure full control of your quality and enable a comprehensive, system-wide overview. Management Quality Center LIMS: Laboratory Information and Management System CAQ.Net 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 CAQ.Net by a number of highly renowned laboratories in a number of industries proves that the combination of a CAQsystem and LIMS functions brings together the best of both worlds for the benefit of product safety and overall production quality. Decades of experience CAQ AG has thirty years of experience in the field of computer aided quality assurance and quality management. Our first customers included a variety of manufacturers from the chemical, pharmaceutical, and foodstuffs industry. Over the decades we have continued to support said customers in the implementation and maintenance of our standard-compliant software solution and many of these customer relationships have since developed into knowledge sharing partnerships. These partnerships allow us to continuously improve our product and rapidly adapt to changing industry demands. The resulting target/actual comparison between CAQ.Net and the most current requirements by manufacturers in this sector, means that our customers are always in command of a cutting-edge software solution that allows professional, efficient, and standard-compliant quality management. Process Management / APQP Document Management Training Management Task Management Supplier Management Audit Management Change Control Key Performance Indicator Management Quality Assurance Inspection Planning / Quality Inspection / SPC / LIMS Initial Sample Inspection Gauge Management Preventive Maintenance Risk Management / FMEA Complaint Management / CAPA Tools / Add-Ons WEB Applications Application of Ishikawa diagrams and 5-Why method for root cause analysis Customizing System Integration / Interfaces CAD Inspection Planning CAQ AG Factory Systems

5 Quality Management Software CAQ AG develops and distributes innovative and all-encompassing quality management solutions for all types and sizes of company. Regardless of whether you are running a local SME or multinational corporation, the challenges faced in today s fast-paced business world call for a quality management system which combines cutting-edge information technology with solid service and highly- skilled support: these challenges call for CAQ.Net by CAQ AG. We place particular emphasis on compliance with industrial standards and consistent releasability of our software solutions and do so whilst offering highest possible customizability in accordance with the wishes and needs of our customers. First-Class References Because no one else knows the detailed ins and outs of specific day-to-day business processes in their company better than our customers themselves, we continually focus on their individual requirements and always listen to what is needed in the field. These synergies allow us put theory into practice and provide standardized, yet highly customizable quality management solutions. Visit our website at and see how some of our most renowned customers describe their success stories. They are happy to serve as guarantor and reference for our powerful, reliable, and fair software solutions. CAQ AG Factory Systems

6 CAQ AG Factory Systems Kastanienweg 1, D Rheinböllen Phone: Fax: Internet: CAQ AG Factory Systems, any use and/or reproduction only with express written permission by CAQ AG Factory Systems. Product and company names and logos used in the brochure may be trademarks or registered trademarks of the respective owners. W610/16