Structured, documented, and risk-based development processes lay the foundation for validation-friendly and GxP-compliant software solutions in the pharmaceutical, medtech, and biotechnology sectors.
Companies in regulated industries face stringent requirements regarding the quality, traceability, and compliance of their software solutions. PeakAvenue addresses these requirements with development processes based on the principles of the GAMP 5 (Good Automated Manufacturing Practice) guidelines.
“As a software manufacturer, we develop our solutions in accordance with the principles of the GAMP 5 guidelines. This ensures that our products meet the high quality and traceability requirements of regulated industries — particularly pharma, medtech, and biotechnology,” explains Cevin Ciullo, Head of Product Support and Vertical Management at PeakAvenue.
PeakAvenue's development processes are structured, documented, and risk-based. Transparent requirements management, traceable testing procedures, and a controlled change management system ensure that the software is developed to be validation-friendly and can be seamlessly integrated into GxP-regulated environments.
“We develop in a structured, documented, and risk-based manner so that our software is validation-friendly and compliant with regulations. Our customers can rely on the fact that our solutions are quality-assured, traceable, and GxP-compliant — in other words, optimally prepared for use in regulated environments,” Cevin Ciullo continued.
Benefits for Customers
- Software development in accordance with the principles of GAMP 5 and ISO 13485
- Documented development and testing processes for efficient validation
- Risk-based quality assurance for maximum reliability and compliance
- Seamless collaboration with QA, quality, and compliance teams
With this approach, PeakAvenue helps companies reliably meet regulatory requirements while increasing the efficiency of their quality and development processes.
