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.
New Functionality
eTMF – eCTD Autoclassification – Save time by using AI to identify and assign meta-data, automatically classify and file any document to the appropriate locations while maintaining Human-in-the-loop (HITL) controls. Learn More.
Intelligent Search – Instant, secure, and affordable access to corporate content, regardless of where the data is stored and whether it is structured or unstructured. Learn More.
RFP Responses – Tap into your historical responses to generate up to 90% of a new RFP automatically — saving time, increasing consistency, and accelerating your path to new business. Learn More.
Streamline the Merger and Acquisition Process – Use AI to identify and sort through documents during the integration stage to streamline the M&A process. AI applies autoclassification and reference checking to identify missing files and organize all files into a predetermined model. Learn More.
AI and Statistical Computing Environment (SCE) – Domino Cloud for Life Sciences (DCLS), powered by Court Square Group’s Audit Ready Compliant Cloud (ARCC) is a fully managed, audit-ready SaaS solution. DCLS delivers an innovative AI and Statistical Computing Environment (SCE) featuring the traceability and governance required to support GxP processes. Learn More.
Generative AI – Efficiently harness and repurpose existing content scattered across organizational repositories to streamline content creation and innovation. Learn More.
Intelligent Application Decommissioning – Alleviate the burden and cost of maintaining legacy systems. Retain and leverage all the content within them in a secure yet accessible manner. Learn More.
Literature Reviews – Keep track of the body of published literature related to your products. Whether for regulatory filings, pharmacovigilance reporting, or monitoring off-label usage. Automatically scan, summarize, and assess every relevant study as it’s published without expanding your headcount. Learn More.
Rescue Trials – Streamline the rescue trial process by automatically classifying, cross-referencing, and integrating critical regulatory documents. Bring structure to disorder, reduce stress, and save valuable time and money. Learn More.
