Mastering Inspector Access: Streamlining Regulatory Reviews
Regulatory inspections can be complex and demanding, but a well-prepared Trial Master File (TMF) can significantly ease the process.
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Streamlining Clinical Data Management for Secure and Compliant Long-Term TMF Storage with eArchive
Effortless Archiving. Seamless Compliance. Enhanced Accessibility.
Trial Interactive’s eArchive is the ultimate method of eTMF audit preparation and retention. eTMF archival is required for regulatory compliance, audit readiness, and data preservation. Active archival ensures clinical trial documents are securely stored and accessible for future reference or regulatory inspections. Trial Interactive eArchive mitigates the risk of data loss, maintains data integrity, and enables efficient document retrieval when needed.
Secure Your eTMF with Advanced TMF Archiving
Regulatory Compliance
Ensure your documents meet 21 CFR Part 11 and ISO 27001 standards, with compliance for up to 25+ years as required by regulations.
Long-Term TMF Storage
Store documents in dependable formats like PDF/A and flat files, maintained in long-term active archiving system that meets regulatory requirements.
Automated Document Retention
Automate document retention management to preserve documents for the necessary duration, ensuring integrity and readiness for audits.
Access and Inspection Readiness
It ensures secure access for regulatory inspectors, maintains a comprehensive audit trail, facilitates easy data retrieval, and prevents broken filing structures.
Integrated eTMF Compatibility
Seamlessly archive documents from Trial Interactive eTMFs or third-party eTMFs, ensuring metadata retention and efficient document retrieval.
Annual Integrity Checks
Annual checksum verifications and backup recovery reports are conducted to ensure data integrity. Audit trails are reviewed yearly to confirm that all files remain intact and easily retrievable in their original form.
Why Choose eArchive?
Reduce the risk of inspection findings with features that simplify trial master file management.
A practical, secure, compliant storage for all clinical trial documents that meets rigorous regulatory standards.
Document management is simplified with automated retention processes, ensuring clinical data security and easy retrieval.
Maintain inspection-ready archives with a comprehensive audit trail, enabling smooth and controlled access for regulatory reviews.
Manage multilingual document submissions and ensure compliance across global regulatory systems.
Eliminate compliance risks with thorough documentation and full audit histories, that demonstrate data integrity and control.
Reduce costs and improve operational workflows with automated processes, with guaranteed quicker approvals and better overall performance.
Latest from our leadership
Trust the Process - Change Management
In this episode of the "Trust the Process" webinar series, host Laurel-Ann Schrader, shares her extensive experience in the clinical trials industry with a focus on TMF (trial master file) inspection readiness.
Avoid Costly TMF Inspection Findings: 15 Key Strategies
In this episode of the "Trust the Process" webinar series, host Laurel-Ann Schrader, shares her extensive experience in the clinical trials industry with a focus on TMF (trial master file) inspection readiness.
