VALIDATION SERVICES

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What are IQ OQ PQ and why are they critical?

We create all documents necessary for the computer system validation for you or together with you. From the validation plan to the validation report. We have been providing this service to our customers for twenty years - our documents have been used in countless audits. Computer system validation aka CSV enhances the reliability of system, resulting in fewer errors and less risk to process and data integrity.

It is intended to reduce long-term system and project costs by minimizing the cost of maintenance and rework. To achieve such long-term goals, it is necessary to implement processes.

CSV is a critical tool to assure quality of computer system performance. IQ OQ PQ or Installation Qualification, Operational Qualification and Performance Qualification are 3 independent and documented procedures used together to check and test that a mechanical, piping or software system is:

  • installed correctly
  • meets its design requirements and specifications
  • operates the way in which it was designed under load

Becoming Validated

During implementations, arivis helps customers establish a focused validation methodology that facilitates the adoption of software upgrades while maintaining quality and addressing risk. As a standard part of practice, arivis supports customers with planning, managing, testing, and preparing for validation. arivis regularly hosts customer audits upon request.

Checklist

Validation Deliverables

  • Master Validation Plan (MVP)
  • Business Requirement Document
  • Installation Qualification (IQ) Protocol
  • Operational Qualification (OQ) Protocol
  • IQ Scripts and Results
  • OQ Scripts and Results
  • Trace Matrix (through OQ)
  • Validation Summary Report (VSR)

  • System Release Memo
  • Configuration Specification
  • Configuration User Requirement Specification (URS)
  • User Acceptance Testing (UAT) Protocol
  • UAT Scripts
  • UAT Summary Report
  • Trace Matrix (through PQ)

regulatory

Scripts

Test scripts defined in DevOps to cover platform and solution configuration

validation

Testing

Automated testing execution for all product updates (regression)

qualification

IQ/OQ

Automatic IQ/OQ execution output deliverables provided

performance

Performance Qualification

PQ test scripts provided for customer execution

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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MORE SERVICES

arivis offers a variety of different services to help our customers with many aspects of the drug development process and document organization.

3D, 4D, 5D Imaging

Full support for building and improving your organization’s imaging competency. We help you improve any part of the process from acquisition to image management.

 
HCS, AI, ML

Process design and improvement for screening that runs with optimal efficiency. We can integrate AI and ML into your arivis imaging science workflows or help you implement them as effective process steps within other imaging infrastructures.

 
Image Analysis

Extraction of results from images of any kind. We use our years of experience in image computing to help you get the best results as quickly as possible.