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Validated Document
Control & eSignatures
A unified environment for clinical, quality, and regulatory documents. Fully compliant with 21 CFR Part 11 and Annex 11, ensuring your electronic records are as legally binding as paper.
CFR Part 11 Readiness
- ✓Audit TrailsAutomated, time-stamped, and non-repudiable logs.
- ✓Electronic SignaturesBi-factor authenticated legal execution.
- ✓RetentionSecure archiving with granular retrieval controls.
Core Enterprise Features
Everything you need for compliant document management
Lifecycle Management
Manage documents from draft to archival with automated versioning.
Signature Manifestation
Automatic appending of signer name, date, and intent to PDFs.
Access Control
Role-based permissions (RBAC) with strict 'Need-to-Know' enforcement.
Authorized Use Only
By logging in, you acknowledge that electronic signatures executed within this system are the legally binding equivalent of your traditional handwritten signature. All activities are monitored and logged. (v1)