Johner Institut
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Authorities and notified bodies regularly make the validation of computer systems the subject of inspections and audits. Many manufacturers and suppliers report to us about repeated complaints and wonder where their computerized systems validation (CSV) reveals gaps and why it is insufficient.
At the same time, there is often a lack of internal resources to deal with the issue in detail, while the working atmosphere is already strained by too much bureaucracy. However, an inadequate validation process can have far-reaching consequences – from major deviations and warnings to the withdrawal of the certificate in the worst case.
Our experts help you set up or optimize a lean, risk-based process to validate your computer systems. We also help you document the process in accordance with FDA and ISO 13485 requirements.
We determine the necessary scope of validation for each of your systems and help you specify the requirements for these systems. Based on this, we create tailor-made validation plans and carry out the validations with you, including the subsequent report creation.
We check whether your software has been developed in accordance with GAMP5 requirements and guarantees Part 11-compliant operation so that you or your customers, as the software operators, can carry out a smooth validation that is waved through by FDA inspectors and QM auditors.
We are also happy to enable you to carry out the validation of computer systems yourself and document it compliantly in the context of an individual workshop. In doing so, we also address your specific questions and resolve any ambiguities for your upcoming audit or inspection.
Comprehensive Expertise for All Software-based Medical Devices and Infrastructures
We are familiar with the legal requirements and all devices, infrastructures, systems, and technologies in the medical technology sector. Our team includes experienced IT and software developers, which is why we offer solutions that are not only legally compliant but also truly practical.
Experienced and Competent Auditors
Not only have our experts already successfully supported many medical device manufacturers and suppliers in validating their computer systems and the corresponding documentation. We also have experienced auditors on our team who know what is really needed in audits and inspections and can, therefore, prepare you in the best possible way.
The Fastest Way to Achieve the Objective with the Least Amount of Effort
We work quickly and efficiently because we know what is important. That means you get your systems validated promptly and without unnecessary effort, and you can be sure you will not have to deal with any time-consuming and costly rework.
Proven Templates
Our team brings templates that have proven themselves in countless audits and inspections. This saves time and money and gives you extra regulatory safety. The authorities and notified bodies also highly value our expertise and the quality of the documentation
Looking to the Future
At the Johner Institute, we have a clear vision of modern, digital quality management. This includes an optimized CSV process in which all unnecessary efforts have been eliminated. For you, this means perfect preparation for tomorrow, including digital transformation. Simply fit-for-future.
Contact us to arrange a first meeting. We will then discuss how to carry out your CSV legally compliant and efficiently.
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+49 7531 94500 20
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Our IT security team detects security vulnerabilities in your software devices early and fixes them so you can launch them quickly and safely.
Our experts help you to achieve a lean and ISO 13485-compliant quality management system without bureaucratic frustration.
Our team helps you effectively protect your data and comply with the requirements of ISO 27001 with a lean information security management system.
Want to gain more knowledge? Our customized e-learning courses, seminars, and workshops are the key.
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