SERVICE
AI validation
The future of validation is intelligent.
State-of-the-art AI solutions are essential
In today's rapidly evolving technology landscape, the integration of AI systems is not just an advantage, it's a necessity. Syncwork is at the forefront of this revolution, providing pioneering expertise in the validation and implementation of AI-powered systems.
With our services, we ensure that your company realizes the full potential of AI while meeting the highest quality standards in compliance with legal regulations.
Artificial intelligence
Immerse yourself in the world of artificial intelligence! We offer you insights, current trends and inspiring applications.
Our offer
What can we do for you?
We offer comprehensive consulting services for the validation of AI systems and models and help you to optimize the validation processes of your AI-supported systems.
Together, we ensure that your data quality and reliability are at the highest level so that you can make informed decisions. Let's revolutionize your validation together.
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Customized validation approach for different types of AI applications
- Standard products (GAMP Cat. 3): Simple, non-configurable solutions such as Microsoft Copilot for Excel and Copilot Chatbot.
- Configurable applications (GAMP Cat. 4): Customized adaptations of existing models through hypertuning of Large Language Models (LLMs) and configuration of AI models of standard products, such as Copilot Studio.
- Customer-specific software developments (GAMP Cat. 5): Internal development of AI models.
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Implementation of key regulatory concepts
- Context of use and risk classification
- Data acquisition and expansion
- Creating data trends using training data and commenting on them
- Development of AI models
- Explainability, interpretability and credibility
- Performance metrics
- Human oversight and "human AI team" (according to FDA)
- Control over the entire life cycle
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Preparation for the operational phaseIncluding change management, operational procedures for dealing with e.g. continuous learning, detection of model deviations, data set labeling and implementation of required actions.
Digital Validation
Digital transformation of validation processes for IT systems, taking into account lean principles and agile working methods.
Decisive advantages
1. Ensuring safety and reliability
Validation ensures that AI systems function safely and reliably under real-life conditions. This is particularly important in critical applications, such as in medicine, where patient safety is paramount. Through validation, potential risks can be identified and minimized.
2. Compliance with regulatory requirements
In many industries, especially in the healthcare sector, strict regulations must be observed. Validation helps to meet these requirements and facilitate approval for the market. This not only protects users, but also promotes confidence in the technology.
3. Improving quality and efficiency
Validation ensures that AI-assisted systems deliver high-quality results. This leads to greater efficiency in workflows and can contribute to better treatment outcomes and cost savings in areas such as healthcare.
Validation of AI systems is not just a technical necessity, but crucial for confidence in intelligent decisions that shape our future.
Robert Neumann | Management Consultant Life Science
About Robert Neumann
Robert Neumann has been contributing his knowledge and experience in the areas of IT validation, project management and requirements engineering for over 15 years - predominantly in the regulated pharmaceutical environment. He has managed numerous validation and testing projects for international life science companies and is now a management consultant and team leader at Syncwork. He is particularly interested in pharmacovigilance systems, cloud technologies, agile validation and the validation of AI-supported systems. He holds degrees in business informatics and several specialist certificates, including IREB, ISTQB and Oracle Argus Safety.
Why Syncwork?
We do things differently
Experience and expertise
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Many years of experience:
Extensive experience in the validation and qualification of GxP-relevant IT systems.
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Early Mover:
Pioneering work in the validation of technological innovations.
Quality and knowledge
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Cross-functional teams for AI models:
Collaboration between validation teams, AI experts and software developers.
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State-of-the-art AI knowledge:
Mastery of LLM, RAG, NLP and GenAI.
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In-depth knowledge of the legal provisions:
In-depth understanding of FDA draft guidance, EU Artificial Intelligence Act, European Medicines Agency (EMA) reflection paper, GAMP guidance documents and GMP guidelines.
Beyond the go-live
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Operational design:
Strategies for seamless operation after implementation, including change processes.
Are you ready?
Transform your business with AI.
Contact us today to find out more about our customized consulting services for the validation of AI-supported systems! Let's tackle your challenges together and ensure your success.
Your path to more accurate and reliable AI solutions starts here!
Curious? We will be happy to answer your individual questions in a personal meeting!