Software for Controlled Documents, Controlled Procedures and Clinical Trials
The regulatory compliance solution for quality management and quality assurance. It can be used in an integrated management system or as modular solution, depending on customer requirements and the roadmap of the digital transformation of the company. Each product is perfectly adapted to the processes of highly regulated (EMA, FDA) industries. QxP opens up a new dimension of regulatory quality!
QxP bundles all regulatory quality processes in one platform. It allows different perspectives on an integrated database. The eDMS covers the compliant control of the regulatory documentation, such as SOPs, and integrates with mandatory training measures and learning success control. The eQMS covers all controlled processes related to quality incidents – deviations, non-conformities, out of specifications (OOS), complaints -, supports change control and action management (CAPA), and allows for the management of audit processes. The eTMF component provides document management support throughout the lifecycle of a clinical trial.
All functional solutions and components follow the PDCA cycle and, hence, support an iterative problem-solving approach. The extensive automation of digital quality processes and workflows ensure maximum efficiency and transparency; an overview of the quality status is available at any time. Quality metrics and quality oversight are decisive for monitoring and controlling quality targets. Therefore, role-specific dashboards, business intelligence and data analytics functions as well as comprehensive reporting options are available “out of the box” to support decision-making.
New dimensions of quality
Focused on quality management, the eDMS digitizes the entire specification documentation and realizes closed-loop processes – from document creation and release to training and learning success control.
The eQMS provides digital support for controlled quality assurance procedures via best practice workflows.
The Trial Master File (TMF) collects clinical trial documents. Clinical trials verify the efficacy and safety of medical devices, forms of treatment, active ingredients, etc.; they are conducted with patients or volunteers. The eTMF ensures the integrity of the clinical data and ensures compliance with Good Clinical Practice.
Validation and compliance without compromise
DHC VISION is specially designed for use in highly regulated industries. The solution fulfills GxP guidelines; technical implementation and business processes are in line with FDA, EMA, PIC/S or ICH directives as well as with 21 CFR Part 11. A solution package is available for system validation. It includes comprehensive documentation for rapid software validation (“Validation Accelerators”); professional validation services respond to specific and complex validation requirements.
Our QxP | Quality Products
The optimal solution for digital management and control of your specification documentation. Secure, controlled, traceable and compliant (including 21 CFR Part 11).
The perfect and seamlessly integrable addition to SOP management. Digital processes set new standards in “Training Compliance”.
If “Read and Understood” is not enough, seccessfull learning is checked at the end of the SOP Closed Loop processes.
Systematic and controlled documentation, analysis and resolution of non-conformancies to improve quality and compliance.
Whether they come from costumers, suppliers or internal processes – complaints are maneged in a controlled manner. This is done with the highest degree of regulatory (process) security.
System processes for Change Control ensure precise management and communication of changes of any kind, from the beginning to the end.
Your information package
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Insight into our costumer relations
“We are now focusing on digitization and, thus, can handle the more complex GxP requirements in a cost-neutral way. Our growth is triggered by value-creating processes rather than G&A costs. We have significantly reduced turnaround times for GxP-relevant documents, need less resources for manual process handling, see more process efficiency and significantly lower risks.”
ITM Isotopen Technologien München AG
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