RegDocs365 is a fully 21 CFR Part 11 compliant, ready-to-use, cost-efficient content and document management solution hosted in an Audit Ready Compliant Cloud (ARCC) validated environment. As a turn-key content management solution built specifically for Life Science companies, RegDocs365 supports life science companies actively bringing drugs, biologics, or devices to market in their efforts to prepare regulatory submissions. RegDocs365 provides a Life Science focused platform for all of your workflow, dashboard and document management needs in a fully regulatory compliant fashion.
Easily streamline workflows at any stage of development through commercialization, including discovery, clinical trials, regulatory submissions, and post-market. RegDocs365 effectively centralizes and manages all digital content (documents, data, voice, and video) to create, protect, and publish in multi-sponsor environments.
With RegDocs365, you are always in a state of inspection readiness. Users can easily manage, categorize, track, and store data from multiple sites and multiple studies. In addition, long-term document retrieval and OCR capabilities allow for quick, accessible content to ensure audit ready access or regulatory requests.
RegDocs365 integrates Artificial Intelligence (AI) tools enabling auto-classification of metadata elements for eTMF and EDM reference models as well as advanced techniques for utilizing content to create intelligent reports. Whether for Form 1572 processing, or Clinical Site Green light reports these tools provide time saving capabilities for your clinical and regulatory staff.
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