Quality management software solutions for the world of medical devices.
Quality management software solutions for the world of medical devices. We are a company that has developed itself from a pioneer in the field of quality-related software back in the 1980s to one of the global technology leaders for management software solutions today.
We see ourselves as tool and solution provider for our customers, as our software enables them to implement superior processes and produce high-quality goods. As the product quality has a direct impact on the success of a company, we believe that we and our solutions directly contribute to said success. Hence, we are not only proud of our own products, but primarily proud of the products of our customers. We aim to always provide our customers with the best, most sophisticated and up-to-date software solutions the market has to offer, in order to support them on their journey to success.
Or in other words: What do Germany’s most successful mineral water, most traditional pencil factory, most exported sparkling wine brand, most renowned medical technology companies, and two of the world’s five largest automotive suppliers have in common? They all rely on our CAQ.Net® software solutions.
We have over thirty years of experience in the area of computer aided quality assurance and quality management for manufacturers and suppliers of medical technology. 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.
We also work in close cooperation with a variety of partner companies who are specialized in qualification and validation procedures in the medical technology field. The resulting target/actual comparison between our software and the most current requirements by manufacturers and suppliers of medical technology means that our customers are always in command of a cutting-edge software solution that allows professional, efficient, and standard-compliant quality management.
Successful quality assurance and management in the field of medical technology 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 all aspects of CAPA management and facilitate the adherence to valid standards and guidelines. This solution is our software CAQ.Net®: your all-inclusive management solution for the medical technology sector.
Or to put it short: We are your reliable partner in all matters relating to quality and are here to support you throughout whatever the digital future may bring.
We all conduct risk analysis in our everyday lives. Every time we weigh up the probability of something happening and the resulting degree of severity, we are conducting risk analysis. If you leave the house when it is raining, the prospect of getting wet is very high. The degree of severity, however, is low. You’ll simply get wet. If you don’t put on your safety belt in the car, the probability of something happening is comparatively low. However, if something does happen, the severity of what may happen can be dramatic.
Complaints are generally rather unpleasant matters. For reasons that are initially unclear, a customer is unhappy with a delivered product or performed service and complains. But what does a complaint really mean if you see it as an opportunity? What exactly can be achieved by consistently analyzing and processing nonconformities? If efficiently analyzed and evaluated, root causes actually constitute an enormous potential for improvement – with regard to technical and process aspects as well as cost controlling factors. Our software REM.Net enables you to turn complaints into opportunities. Use the highly-refined analytical tools, cost management functions, and methods for root cause analysis in the software in order to comprehensively screen complaints and be able to react immediately.
Choosing the correct supplier is often one of the most important factors for the success of a company. The reliability of shipments and the quality of acquired goods are initial aspects that set the course of the subsequent value chain and are some of the most important factors for production companies all around the globe. Good supplier management is especially important because false decisions made at this early stage can seldom be corrected later. What truly counts is quality right from the beginning on.
By questioning, observing and listening, the auditor checks how the company is developing and whether guidelines are being adhered to: audits are indispensable for maintaining standards. However, they are more than just a necessary evil, because if they are professionally managed and analyzed, they offer a multitude of possibilities for process optimization in the company.
Gauges are essentially the sole interface between the measured object and the measured value and it is safe to say that this value lies at the beginning of all quality management efforts. If, for whatever reason, the value is not measured correctly, all subsequent QM processes such as incoming/outgoing goods inspections will be in vain.
We know that, whatever area of business you operate in, the consistent training of your employees is a major key to the success of your company. Expertly trained employees, whose level of knowledge is always kept up-to-date are generally more motivated, creative, and very often contribute fresh ideas and problem-solving techniques. That is why we created our training management software Qualify.Net, which comes with a whole host of must-have functions for employee training and qualification management.
Document management is about much than merely fulfilling the requirements of standards and regulations. It is about structuring and controlling company processes and production workflows. Suitable documentation and the transparent visualization of processes, responsibilities, targets, and risks directly assist companies on their way to successful business conduct.
Process.Net is a software that allows you to define, plan, document, and publish all processes within your company in a standard-compliant manner. Whether the mapping of company processes, procedural instructions, responsibilities, or organization charts: with Process.Net you have a powerful software for process visualization and workflow management at your disposal, with which you can create a clear, understandable and logically structured documentation for your company.
The R&D department at CAQ AG has researched the application of machine learning and artificial intelligence (AI) in order to identify non-valid measurement values. This knowledge today already comes to use in shape of a new type of data validation that facilitates the analysis of process deviations via the CAQ.Net software suite.
The new API in CAQ.Net facilitates real-time communication with virtually any third-party application. It allows you to integrate our software into any element of your IT-system landscape and to depict almost any CAQ.Net function within your MES, ERP, or individual app – thus paving the way for an Industrial Internet of Things (IIoT).
In the area of quality management, it is almost impossible to meet the strict requirements of standards and guidelines regarding the handling of documents without holistic and fully integrated document management software.
All departments in a company regularly face the job of fulfilling projects. The initial aspects generally revolve around questions such as how to best fulfil the project target or how much time the project will require: who should do what when? This is where the project management software Projects.Net comes into play. By drawing personnel and scheduling matters into consideration and combing this information with various workflow-specific aspects, Projects.Net facilitates a well-structured project management that assists companies throughout the completion of targets.
It’s audit-time again and the auditor wants to see just how well the company is in control of its quality management system. Amongst other aspects, the auditor is primarily interested in the company’s processes. Ah yes, there’s that word again – “process”. Regardless of whether ISO 9001 or ISO 13485 certification, all these standards require that responsibilities and workflows are recorded in writing in shape of expressive process descriptions. How well these process descriptions are thought through and designed can, amongst other aspects, be the factor that decides whether certification is successful or not.
Implementing digital concepts such as e-learning helps companies to develop the full potential of their employees and thereby set the course toward sustainable success.
Nothing happens without a reason – effects are always the result of a cause. Unfortunately, detecting causes is not always easy, as effects are usually the result of a complex and often convoluted series of causes.
Whether organizing company structures, depicting responsibilities, or communicating interdepartmental SOPs – processes are the centrepiece of corporate leadership and the key to successful company management and product development. Apart from structuring day-to-day business, the transparent visualization of processes, responsibilities, targets and risks also directly assists companies on their way to successful certification.
As a software user you sometimes come to the point where you think: wouldn’t it be nice? Wouldn’t it be nice if you could make this field a mandatory field? Hide this field and rename that one? Insert an additional button right here that opens an external program or calls up a website? Customize this form precisely to meet the needs of a particular customer?
Gauges are essentially the sole interface between the measured object and the measured value and it is safe to say that this value lies at the beginning of all quality management efforts. If, for whatever reason, the value is not measured correctly, all subsequent QM processes such as incoming/outgoing goods inspections, SPC, or quality planning will be in vain.
In order to maintain quality criteria, and in response to attaining certification satisfying DIN ISO 9001 and DIN ISO 13485, Boehringer Ingelheim microParts GmbH decided to employ CAQ AG’s software for quality control. “What began in 1995 with a single module for gauge management has since been expanded into a complete CAQ.Net server-based system with unlimited licenses to satisfy the high-quality demands of Boehringer Ingelheim microParts”, explains the quality management supervisor at Boehringer.
July 2011 marked an important milestone for Berlin Heart GmbH. The advisory council of the US Food and Drug Administration (FDA) unanimously agreed that the EXCOR® Pediatric cardiac support systems be approved for use in the USA. Berlin Heart had laid its trust in CAQ AG’s software solutions in order to be able to convince the FDA of the high standards of quality employed in its products and processes. The head of IT at Berlin Heart, is convinced that “Approval for use in the USA would not have been possible without the implementation of a consistent CAQ-System”.
Medical technology producers and suppliers have to submit to the high demands of European medical production standards and those of the US Food and Drug Administration FDA. In order to meet the general requirements of these quality standards for validation and for quality management purposes, Samaplast AG, the Swiss specialist for plastic die casting, relies on CAQ AG Factory Systems’ software solutions.
Even though the company has its roots in the production of automotive parts, the medical technology sector is becoming increasingly important to Quinger GmbH. Today one third of the company’s products are medical technology. From a quality management perspective this means that Mr Quinger has the privilege of working in two of the most demanding industries. It was with extremely high customer demands in mind that a certified QM-system was set up in the year 2000. In 2011, this system was taken to an all new level by the implementation of CAQ AG Factory Systems’ modular quality management software solutions.