QUALITY PROCESSES

DEVIATION MANAGEMENT

Quality process

Taking Compliance to the Next Level with a Robust Deviation Management

The management of deviations is not just a GMP concept, it spans the entire product life cycle, including Good Laboratory Practices (GLP) and Good Clinical Practices (GCP). Further Process Deviation Management is about capturing, analyzing and managing data and improvement actions related to process deviations. Process deviations can be about operations, HSE, and quality. The essence is to understand which controls or barriers have failed or proven to be reliable – and why this is the case. 

GMP Deviations

At a minimum, GMP requires written procedures for the following:

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

Additionally, while there are various GMP standards, each of them, whether ICH, the FDA, or the EU GMP standard, requires the documentation of any deviation.

 

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Clinical Protocol Deviations

An efficient deviation handling system should implement a 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. The key principles are: build on ICH E3 Q&A R1 of "Protocol Deviation"

  • The event occurred
  • The event is related to a data point or processing the protocol or documents referenced in the protocol
  • Protocol deviations are independent of fault, blame or circumstance

For "important protocol deviations" as a subset of protocol deviations which can significantly impact key study data, ICH E6 R2 must be incorporated.

Reference: 

 

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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 rewards the company with improved business processes, efficient workflows, decreased project overhead, a better risk profile and an improved company culture. 

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High Content Screening

High-content screening (HCS), also known as high-content analysis (HCA) or cellomics, is a method that is used in early development stages and drug discovery to typically identify substances such as small molecules, peptides, or relevant RNAi that can lead into development candidates for future medicines. 

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Image Annotation

With the development of diagnostic imaging devices, large amounts of digital high-res and 3D images are generated every day. The requirements of effective indexing and searching image are growing rapidly. Image annotation is an effective way for content-based image retrieval. 

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Remote Image Analysis

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Inspection Management

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Raw Data Management

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eTMF and Archiving
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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.

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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.

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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 
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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
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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
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Electronic signature Lifecycle
Automated indexing of all data
Integr. electr. long term archive
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BM-Flow

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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

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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.

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Integr. electr. long term archive
Instrument monitoring

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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

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Smooth Rendering and Visualization
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Register and browse image and data
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RESOURCES

INDUSTRIES

Biotech

The broad concept of “biotechnology” or also known as "BioTech" encompasses a wide range of procedures. The global market for the biotechnology market is primarily driven by technologies like DNA sequencing, nano-biotechnology, tissue engineering and regeneration, cell-based assay, PCR technology, and others. Explore the flexible solutions for emerging BioTech

 

Pharma

The pharmaceutical industry develops drugs or devices to diagnose, cure, treat or prevent diseases. Pharmaceutical companies produce both generic and branded drugs. Pharmaceutical drugs are subjected to various laws and regulations that deal with patenting, testing, safety, efficacy and marketing. Pharmaceutical drugs are intended for human or veterinary use presented in their finished dosage form. Learn more about the Process excellence of arivis in Big Pharma.

 

CRO

A contract research organization (CRO) is a company that offers services to the pharmaceutical and biotechnology industries. These companies partner with various companies and organize and conduct clinical trials to test the new molecule before obtaining approval. Contract manufacturing organizations (CMO) offer manufacturing services, with volume capabilities ranging from small amounts for preclinical R&D to larger volumes necessary for clinical trial purposes and commercialization. See how arivis enables functional service provision with CROs.

 

CMO

A contract manufacturing organization (CMO) is an organization that serves the pharmaceutical industry and provides clients with comprehensive services, from drug development to manufacturing. Outsourcing to a CMO allows the pharmaceutical clients to expand their technical resources, without increased overhead. Arivis offers solid solutions for contract manufacturing.

 

GLP Laboratory

Third-Party Laboratories for GLP Testing, contract testing laboratories. Pharmaceutical manufacturers contract out any quality control testing, will need a licensed laboratory, certified as a GMP or GLP. The GLP laboratories are designed to protect scientific data integrity, and to provide the EPA or FDA with a clear and auditable record of open-ended research studies. With a arivis you are committed to integrity with contract testing laboratories.

 

Academic Institutions

Institutions in this industry offer academic and professional courses and confer baccalaureate or graduate degrees. In the US major institutions include public university systems in states such as California, New York, and Texas, and private universities such as New York University, Duke, Harvard, and Johns Hopkins. arivis cultivates long term partnerships in academic research.

 

Diagnostic Microscopy

Microscopes have enabled researchers to conduct in-depth academic and exploratory research. The biomedical research and engineering sector is driving innovation by microscopy techniques to produce better and more informative images of cellular functions, including internal images of cells.