QUALITY

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Smart Business Processes

Data Driven Decisions lead to Solid Compliance

Excellence in the various Quality processes is paramount throughout the whole life sciences industry. Medicinal products and devices, which have the potential to drastically change lives, must be developed with frictionless quality systems in place, to ensure controlled documentation and end-to-end compliance at any time. Quality assurance as such is a pretty broad concept. It covers all aspects of your process that can have an impact on patient outcomes.

The risk of not implementing comprehensive quality systems is well documented. The numerous yearly findings of authorities like FDA or EMA can still be devastating to a company with poor performance in quality.

Such findings can lead to substantial costs related to corrective measures, remediation and blocking of sites and product. Companies can face external costs like regulatory action, massive reputational damage, and a loss of market share.
US-based pharmaceutical organizations should work to assess and understand the following regulatory requirements from the Food and Drug Administration (FDA), including clinical requirements:

If your marketing ambitions post-approval include Europe, you should strongly consider aligning your quality system to ICH Q10 earlier in your development.

TOUCH

PROCESS

PROCESS

Continuous Improvement

Constantly verify the consistency of existing processes and whether existing specifications are appropriate and adequate.

TOUCH

PRODUCT

PRODUCT

Current Good Practice


GxP - the implementation of quality principles  for raw materials, the manufacturing process, packaging, transportation, and storage.

TOUCH

PEOPLE

PEOPLE

Quality-Driven Culture

Besides the obvious process excellence, a proper product the quality-driven culture remains a main factor to achieve quality.

Related Sub-Processes in Quality

arivis-quality-audit-management

Audit Management

The increasing complexity and continuous changes in the regulatory environment push organizations to seek a more holistic and highly integrated approach to their audit management processes. Auditing is a vital function within a pharmaceutical company nowadays CAPA Management

HIGHLIGHTS

  • External audits
  • Internal audits
  • Regulatory audits
 

arivis-quality-CAPA-management

CAPA Management

To understand how to achieve quality in a regulated industry, you need to know that corrective and preventative actions (CAPA) are essential elements of quality management in GxP environments. The CAPA process is a commonly used tool to achieve operational excellence by identifying and mitigating non-conformances and deviations, both internally and externally.

HIGHLIGHTS

  • Event Mapping / Audit Scheduling
  • Structured Problem Analysis
  • Multidimensional (faceted) Search
  • Smart Follow-up Workflow
  • Effectiveness Check
  • Indicators and Signals
 

arivis-quality-SOP-management

SOP Management

Life science organizations developing or manufacturing pharmaceutical products will typically create, maintain and execute large amounts of standard operational procedures (SOP). The solid change control and deployment of SOPs are a fundamental to achieve compliance excellence.

Properly designed Standard Operating Procedures include step-by-step instructions as well as the following:

HIGHLIGHTS

  • Objective (Purpose)
  • Scope
  • Responsibilities
  • Accountability
  • References
  • Task Instructions (Procedure)
  • Documentation
 

arivis-quality-change-control

Change Control

Change management is specifically designed to evaluate, redesign, and implement new business processes, where processes are defined in standard operating procedures (SOPs). A well implemented change management pays back into improved business processes, efficient workflows, decreased project overhead, a better risk profile and an improved company culture.

HIGHLIGHTS

  • Collaborative authoring and editing
  • Document review and approval
  • Document protection and monitoring
  • Document control and printing functions
 

arivis-quality-training-management

Training Management

Post implementation training services often relateto process changes. With arivis training services implementations are ready for success. The arivis5D Learning Management System (LMS) typically handles the processes related to ramp-up and adoption planning after larger implementations.

HIGHLIGHTS

  • Upload content
  • Deliver courses online
  • Onboarding process
  • User Enrollment, Learning plans
  • Ramp-up new users
  • Tracking and assessing learner performance
 

arivis-quality-deviations

Deviation Management

As a common mechanism to discriminate events based on their relevance and to objectively categorize them, concentrating resources and efforts in good quality investigations of the root causes of relevant deviations.

HIGHLIGHTS

  • Control of components, drug product containers, and closures
  • Production and process controls
    Packaging and labeling control
  • Holding and distribution
  • Laboratory controls
  • Complaints
 

arivis-regulatory-inspection-management

Inspection Management

Audits, safety inspections, engineering surveys, and quality checks are common in life sciences. While they add overheads, they are necessary to keep organizations in business.

HIGHLIGHTS

  • GMP inspections
  • Contract manufacturers (CMO)
  • Contract laboratories
 

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

RESOURCES

“Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skillful execution; it represents the wise choice of many alternatives.”

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