Data integrity has always been a critical point during the development of eTMF systems. One of the industry’s latest standards is ALCOA++, and our eTMF module is 100% compliant with ALCOA++.
eTMF (electronic Trial Master File)
eTMF – complete 24/7 visibility into all your trial documentation
Have a helicopter view of eTMF processes at any point of time
- Get instant safe access to your trial documentation from any place in the world.
- See missing documents, files uploaded statistics, folder completeness by milestone or any other parameter.
- Focus on the most relevant tasks with automated to-do lists, flexible widgets, and exportable reports.
Tools designed for your daily activities
- Upload documents in seconds – email a document directly into eTMF or through an app on your phone, or drag and drop into eTMF, connect your computer through WebDAV or just browse and upload
- Anything you prefer and used to works. eTMF integrated with CTMS, all CTMS documents are filed in eTMF with zero effort from you
- Need one place to review, assign metadata and distribute documents to a correct folder? We got you covered with eTMF Manager space
- Need to send documents in bulk to sites? Email it from eTMF with a track record
- Review, approve, lock, sign, author documents with embedded eSignature function
Simplicity without compromising quality
- Periodic review of eTMF is finally easy with My views tab to choose a list of documents for review and use inbuilt chat function to query and correct a document
- Inspection readiness is not a challenge anymore – it is a daily state of your eTMF
- Regulations are met, validation is complete, audit trail is there
- Archiving function, logs and external access designated for inspectors, auditors, partners is there too
- No excessive training required
- Simple TMF template creation and configuration, including DIA Reference Model
- E-mail blasts from TMF to sites
- OCR – system recognize text in pictures, scans, photos
- Online viewing and authoring via browser without download
- Email alerts
- Flexible access matrix
- Web-based: no installation needed
- The system can be hosted both cloud-based and on-premise
- Single sign-on functionality is available using LDAP and SAML protocols
- API is available for use in bidirectional integrations
- System recognizes special /foreign characters
- 21 CFR Part 11 compliant
- Access control, based on project role, sites, folders, countries and for external users
- Full Audit Trail and versioning
- Easy archiving of eTMF project with index and audit trail
- Fully validated, all related documentation is provided
- Automated filing of documents from CTMS
- Email upload – send email with attachment directly to eTMF
- Batch documents upload and download
- Drag and drop function
- TMF connected as an external drive through WebDAV protocol
- Mobile application
- Adjustable notifications and alerts
- My Views section – user-defined lists of documents based on metadata groups
- QC Workflow for all file types, folders and placeholders
- Chat and comments available for documents and folders
- Documents review, approve, lock, sign configurable workflow and electronic signature
- Real-time statistics on folders completeness
- Business Intelligence: widgets and reports
- Ad-hoc reporting tool for cross-project & cross-module reporting
- Powerful search engine by various parameters in name and file content
- Custom metadata setup and management
- Various metadata structures templates
- Metadata actions (e.g. notification on expiry date of the document)
- Dynamic metadata reports
What sets Flex Databases apart
We can deliver a fully functional system in the timeframe from 3 to 10 weeks, depending on the сlient involvement and requirements.
Complete data safety
We have a robust backup & disaster recovery and customer data protection strategy, including distributed data storages around the world.
Flex Databases is compliant with all major international and local regulations such as: ICH GCP E6 R2, FDA 21 CFR Part 11, GDPR, etc.
Easily configure every part of our proprietary platform. The system is fully managed by end users. No installation required.
What they say about us
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