Validation Talk
Experience reports, specialist presentations and discussions: Experts from the life science industry come together once a year at the Validation Talk to discuss current developments and learn from each other.
Validation and qualification
Validation and qualification of processes and systems in the life science sector are essential to ensure the highest quality standards and regulatory compliance. Systematic approaches ensure that products are safe and effective, which ultimately strengthens the trust of patients and regulatory authorities. Optimize your quality assurance strategies with us!
Digital validation
We transform your validation processes: digitally, integrated and continuously. We take the entire product life cycle into account with the help of lean principles and agile working methods. From the planning phase, through analysis and design, implementation, automated tests and deployment to release, we think the process digitally - including risk management as a central core element
AI validation
Validation of AI applications in the life science sector is crucial to build trust in innovative technologies and meet regulatory requirements. Robust validation processes can ensure that AI solutions are accurate, reliable and safe for use in critical areas. We ensure that you realize the full potential of AI.
Test management in the life science sector
Effective test management in the life science sector ensures the quality and compliance of products by integrating precise test methods and traceable documentation. By using modern technologies and agile approaches, it is possible to react more quickly to regulatory requirements and at the same time ensure patient safety. With us, you will find the right testing approach for your IT systems!
scarabPLUS – The all-in-one pharmaceuticals solution
Get to know scarabPLUS! Syncwork's complete pharmaceutical system has been an important part of the product portfolio for over 20 years and is aimed at medium-sized companies in the regulated industry. It offers a unique depth of functionality in the pharmaceutical manufacturing sector and can also be integrated into existing ERP systems.
CSV-audit
Due to technological advancements, increasingly complex systems are being used in the life sciences industry, particularly in GxP-relevant areas where patient safety, data integrity, and product quality are paramount.
With our CSV-audit, you can ensure that your computer systems comply with all necessary regulatory requirements.
Computer System Validation (CSV) / Qualification
Validation testing and requirements analysis form the basis for configuration and change management.
The process also includes the qualification of IT infrastructure and laboratory equipment, as well as requirements engineering and system analysis.
Test management and test control
GxP-compliant tests are designed using a risk-based approach, automated in a targeted manner (particularly for regression testing), and verified, executed, and documented as part of CI/CD pipelines.
Process modelling
BPMN-based, systematic analysis and modeling of processes using various tools, development of consistent process landscapes, and implementation of modern automation tools.
Data integrity
Risk management, data classification, and security planning form the foundation of a secure IT environment. Together, SIEM and the ALCOA(+) principle ensure the integrity and monitoring of all security-related data.
Software development
GxP-compliant development, documentation, configuration, and customization of applications and platform architectures. This includes business intelligence, ETL, and innovative solutions using AI, RPA, and low-code (Appian).
Applications
These systems support processes in the areas of quality management, pharmacovigilance, and documentation. They include Atlassian, Oracle Argus Safety, HP ALM, TrackWise, MasterControl, Documentum, FirstDoc, and CARA.
