REGULATORY

REGULATORY

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Regulatory Business Process Management

arivis started with the first ever cloud-based eDMS system designed for life sciences in 2005. We enhanced these tools with the addition of eCTD Regulatory Submission Management along with full Virtual Data Room capabilities. Now arivis Clireo provides the only Azure based Clinical eTMF and ISF with full eDMS capabilities. 

And Clireo eMPM supports end-to-end Promotional Materials Management for Medical, Legal, and Regulatory review and approval. Combined with Clireo eCTD and the new Module 1 for the FDA eCTD, Clireo creates the industries only integrated Promotional Materials Management system with integrated eSubmissions capabilities.

arivis-regulatory-submission-planning

Submission Planning and Management

arivis started with the first ever eDMS system that integrated Business Process Management (BPM). We enhanced these tools with the addition of eCTD Regulatory Submission Management along with full Virtual Data Room capabilities. Later we introduced more regulatory submission management capabilities with support for 510k, PMA, and custom submission types. 

HIGHLIGHTS

  • Regulatory documents

  • DIA EDM Reference Model

  • Submission signposting

  • Lifecycle & workflows

  • Dynamic permissions

  • Metadata

arivis-regulatory-inspection-management

Inspection Management

Regulatory agencies conduct routine inspections during active studies. In this case, documentation must be available and complete, ensuring that the study was conducted following the protocol using the principles of Good Clinical Practices (GCP).

HIGHLIGHTS

  • Scheduling enable the organizations to manage inspections

  • Mapping and tracking of observations to issues and CAPA items

  • Track progress and effectiveness of corrective measures

arivis-regulatory-inspection-management

Regulatory Correspondence

A timely, transparent, and effective communication between sponsors and authorities are paramount during regulatory operations in drug development and can facilitate earlier availability of safe and effective drugs to patients. At the same time, it reduces frictions with later steps in the approval process.

arivis5D Platform

arivis5D-imaging

product-image-arivis5D-imaging

Comprehensive Imaging Science solution for research and production imaging processes.  Process support that covers the whole workflow from imaging to conclusions. Improve and integrate image production, data ingestion/archiving, storage, access, analysis strategy, QA/QC, computation at scale, review of results, and implementation of custom algorithms and AI.

Configurable by subject matter experts
Scripting interfaces
Workflows for optimization at every step
Accelerated computation for projects
Results in space and time on image volumes
Access any portion of image at any time
Connect datasets & results across projects

arivis5D Platform

arivis5D-compliance

product-image-arivis5D-compliance2

Quality Management System with features to secure and control data & documents. Collaborative platform for regulated content, processes and end-to-end compliance along the complete life sciences life cycle. Powerful and intuitive navigation, enhanced user experience, dynamic content management and search features. Connecting quality teams globally.

Controlled assets and documents
Collaborative platform for regulated content
Processes and end-to-end compliance
Workflows along the complete life sciences life cycle

arivis5D Platform

arivis5D-protocol

product-image-arivis5D-protocol

Trial Master File solution to securely review and audit TMF documentation. Digital process support with form-based workflow for the complete (pre-) clinical document processes. Visualize real-time completeness based on study, country and site indicators. Apply filters and different dimensions, view metadata to intuitively navigate through complex eTMF filings

Audit savvy Trial Master File solution 
Digital and process centric approach
Real-time indicators on all levels
Intuitive navigation in various dimensions based on metadata
Fully integrated with CTMS workflow events and triggers

arivis5D Platform

arivis5D-information

product-image-arivis5D-information

Document and project management solution for life science. Tools for operations and oversight teams to prepare and review documents and records for the completion and successful submissions and correspondence. User centric collaboration, automation and quality workflows featuring the life cycle of documents and dossiers from authoring to (re-) submission.

Document, asset- and project management
Operations and oversight
Collaborative review for submissions and correspondence
Automation and quality workflows from authoring to (re-) submission

arivis5D Platform

arivis5D-rawdata

product-image-arivis5D-raw-data

arivis BM-Watcher is a 21 CFR Part 11 raw data management solution for the pharmaceutical industry.  It integrates with nearly all types of laboratory instruments. It is able to provide data integrity features even for legacy systems. arivis BM-Watcher is an agent that is able to monitor the file storage of a laboratory device. 

Access control
Audit trails
File versions
Electronic signature Lifecycle
Automated indexing of all data
Integr. electr. long term archive
Instrument monitoring

On Premise

BM-Flow

product-image-BM-Flow

Complete document management, training management, CAPA, deviations, change control - all in one tool.

Inbox for all types of tasks: documents, QA processes, training
Configurable document workflows
Configurable forms, workflows and reports for CAPA, deviations, change control (and many more)
Digital signatures - certificate based. No third-party tools required.
Training plans, training organization, reports on trainings
Quiz module

On Premise

BM-Watcher

product-image-BM-Watcher

arivis BM-Watcher is a 21 CFR Part 11 raw data management solution for the pharmaceutical industry.  It integrates with nearly all types of laboratory instruments. It is able to provide data integrity features even for legacy systems.

Access control
Audit trails
File versions
Electronic signature Lifecycle
Automated indexing of all data
Integr. electr. long term archive
Instrument monitoring

arivis-Vision4D

teaser-Vision4D

Modular software toolkit for extracting results from scientific images. Adjusts to hardware for maximum power and smooth interactivity on image datasets of unlimited size. Brings diverse tools into one environment and enables users to connect them into productive workflows. Highly interactive for optimization and quality at every step. Extendible directly via Python and connectable to other applications via libraries.

Tile Stitching
Data Transformation
Image Preprocessing & Enhancement
Segmentation
4D Tracking & Lineage
Batch application of Analysis Pipelines
Custom Computed Features of Objects
Exploration of Results overlaid on raw data
Interactive rendering of volumes and time-series
Cinematic high-resolution rendering

arivis-VisionVR

teaser-VisionVR

Display real image data in Virtual Reality by utilizing patent pending direct volume rendering techniques with no need to convert data or make surface models. Directly use your hands to move, rotate, scale, and shape your digital image data. Interactively proofread, edit, track or segment multi-dimensional images from nearly any source instrument.

 

Smooth Rendering and Visualization
Collaboration via different VR Scenarios
Direct Volume Rendering
Export Snapshots, Movies and 360°
Seamless Exchange with Desktop Application
Sculpting Tools to Add, Delete and Proof-read
Magic Wand Tools

arivis-VisionHub

teaser-VisionHub

A nucleus of computational activity and collaboration at scale. VisionHub enables design and execution of large-scale experiments that produce results from images, whether datasets are already stored or are actively being produced. Mass quantities of Imagery are onboarded and processed by a virtual team of computational workers. Smartly utilize processing cores in servers or workstations with the maximum speeds possible.

Register and browse image and data
Manage access for users and groups
Import and archive datasets into the arivis framework
Create experiments that produce results at scale
Leverage computational resources onsite and offsite
Scalable pricing model to support bursts of throughput
Visualize massive image volumes via remote rendering servers
Implement quality checks for increased efficiency and validity
Smart optimization of parallelization

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"The only way in which to treat the elements of an exact and rigorous science is to apply to them all the rigor and exactness possible."