eTMF – A Clinical Investigation Documentation System
Enhance your clinical studies with our user-friendly, cost-effective, and regulatory compliant eTMF (electronic trial master file) system. Tailor-made to fit your local or international needs, this all-in-one solution simplifies clinical study documentation and improves efficiency.
Key Features:
- Regulatory Compliance: ISO14155:2020 compliant for all essential clinical study documents.
- Document Creation and Management: Easily create, send, and email documents directly to the Focalcube inbox.
- Active Support: Personal support available via email, phone, and Teams chat for all system-related queries.
- Eco-Friendly: Reduces ecological footprint by transitioning to an online eTMF.
- Comprehensive Documentation: Final checking and documentation ensure a complete eTMF.
Optional Features:
- Electronic signature capabilities.
- Direct mailbox integration into eTMF.
- Digital or final archiving solutions like USB flash drives or zip files.
Why Choose GBA Key2Compliance® eTMF System:
- Ease of Use: Powered by Focalcube, designed designed for user-friendliness and regulatory alignment.
- Tailored Structure: Folder structure customized to ISO14155:2020 standards.
- Efficient Document Handling: Quickly locate, manage, and create documents, with full revision history tracking.
- Integrated e-Signatures: Legal electronic signing with Assently integration.
- Flexible and Powerful: Ideal for MedTech companies, supporting both new studies and the transition from paper-based systems.
Switching to our cloud-based system enhances efficiency, offering full control for remote audits and inspections. Maintain high-quality standards and secure access for both internal staff and external users.
GBA Key2Complience- eTMF
Discover more about how we can revolutionize your clinical study documentation with our advanced eTMF solutions. Visit the GBA Key2Compliance website to explore the full range of features and benefits we offer and see how we can tailor our system to meet your specific needs.