GxP Archive
GxP Archive
GxP Archive: Archiving without migration, directly from your eTMF and other content.
Specialised archiving solutions have a catch: Before your data is secure, it first has to get there. Exports, mapping, migration projects and additional supplier qualification take up time and budget, and every transfer poses a risk to data integrity. Docuply takes a different approach: the GxP archive is firmly integrated into the platform where your Trial Master File and your quality management system are already housed.
At the end of the trial, you can archive your TMF with just a few clicks. Docuply checks in advance whether all documents are present and approved, transfers them to an unalterable archive status and converts them into long-term stable formats such as PDF/A. This applies equally to SOPs, training records, supplier files and other QM content. CROs hand over the archived TMF to the sponsor in a structured format, and with the complete export—including metadata—you remain independent at all times. Your data is stored with six-fold geo-redundancy across two EU countries, operated by a German company certified to ISO 27001. This enables you to comply with the retention requirements set out in EU Regulation 536/2014, ICH E6(R3), EU GMP Annex 11 and 21 CFR Part 11, without having to validate an additional system.
- No media break: archiving directly from eTMF and eQMS, without the need to migrate to a third-party provider.
- Archiving in just a few clicks: Automatic completeness check before each archiving step.
- One archive for everything: TMFs, SOPs, training records, supplier files and other quality management content.
- Data that won’t be lost: 6-fold geo-redundancy across two EU countries, ISO 27001-certified and operated by a German company.
- Verifiable integrity: Locked archive status, regular integrity checks and a blockchain audit trail.
- Readable in 25 years: Automatic conversion to long-term formats such as PDF/A.
- CRO handover and exit: Structured handover to sponsors and full export, including metadata.
- Inspection-ready: Role-based read access for inspectors and auditors, without the need for prior data recovery.
Experience for yourself in a personalised demo just how easy GxP-compliant long-term archiving can be. In 30 minutes, we’ll show you how to securely archive your TMF and QM content for decades to come.
