F.A.I.R.

iPQM

best practice - iPQM-intelligent pharma quality management
QMS, qDMS, CAPA, Image QC, Issue Management

best-practice

Compliance Framework

Compared to techniques based on paper, the neuronOS Compliance framework is an Electronic Quality Management System (eQMS) that offers a holistically integrated and computerized approach for pharmaceuticals, life sciences, genetics, medical devices, and related industries, operating effectively on one platform for all units. The cloud-based platform, neuronOS, provides a stage for quality monitoring modules that facilitates maintenance flexibility and transparency. In a controlled environment, this methodology benefits from an extended period of experience with Life Sciences consumers, CROs, and medication product producers. neuronOS aids our clients to follow and implement a specific set of guidelines that are set and modified by universal regulators.

The design of the neuronOS System Software focuses entirely on the current and potential customer requirements that are essential for its accomplishment.
Given the immense pressure on the Pharmaceutical, Biotech, Medical Devices, and Life Sciences companies to respond to evolving market conditions, there is a need for advanced management technologies that can help pharmaceutical and life sciences industries gain a considerable advantage with new approaches to R&D.

neuronOS Life Sciences and Pharmaceutical Quality Management System (QMS) software comprises the potential to systematize and streamline corporations. Furthermore, to ensure superior product quality and delivery pace, it fluently allows the improvement of manufacturing processes.

 

Infographics neuronOS best practice applications-iPQM

WATCH+


Decentralized intelligent agents execute defined missions that correspond to actual stages of defined cloud-based business workflows, carrying capabilities to ensure end-to-end compliance.

COMPLY+


Mitigate data-security breaches, financial risks and keep your company’s reputation. Overcome data silos that prevent standardization, transparency and compliance. Accessible to advanced AI.

ARC+


In addition to storing and managing documentation online, neuronOS with ARC+ allows for digital assets to be migrated, federated, archived while staying GxP compliant at any time.

BRAIN+


Adds AI powered indexing and archiving to innovative digital asset management for higher quality output and better decision making, enabled by machine learning & data automation.

BYOD+


Add value and simplify data acquisition through smartphone apps, which can check-in pictures, text, audio and data sets into any GxP compliant process, living on the neuronOS platform.

IMAGE+


Embed interactive image spheres of high resolution and complex 3D and 2D images or simply present static images with textual, visual and audio annotations.

REPORT+


Integrated reporting with dashboards and live filtering. Designed with the information demands of authorities and the public in mind, a more practical and reliable reporting can be excelled.

SIGN+


Create a digitally signed validated archive, which can be viewed instantly for inspections and demonstrates data integrity and accessibility via the neuronOS cloud service.

TRAIN+


Deploy effective and timely SOP training records and analyze the training status in your organization prior to inspection findings. Keep training records consistent
for long-term archiving.

MIGRATE+


Integrate diverse eTMF and Clinical Data from various sources and CROs to accelerate your research with decentralized trials. Access raw & processed Data, analyze multiple eTMF sources, integrate CRO data in sponsors eTMF archives.

designer

Designers can design

Design is not only the most effective differentiator but also has a huge impact on usability of a product. Bringing all aspects of a users experience down to a consistent and frictionless system of colors, forms and shapes with optical and ergonomic advantages demands for a holistic view on human interaction with machines.

DIGITAL, DECISIVE, COMPLIANT
AND INSPECTION-READY

engineer

Engineers can build

Building requires a vast amount of abstraction not only in a mechanical world also in virtual systems Which should be able to interact between humans and machines in order to reach intended goals and create systemswhich are resource concious

DIGITAL, DECISIVE, COMPLIANT
AND INSPECTION-READY

sales

Salespeople can sell

The perfectly engeneered product with even a wonderful design cannot be successful in the market, without someone, who finds the market and points out the advantages for a prospective customer. Selling products that solve complex problems is an art in it self and involves a good understanding of technology, user and psychology.

ALL DIGITAL, DECISIVE, COMPLIANT, AND INSPECTION-READY


Related Processes

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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.

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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. 

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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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Deviations 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) and Process Deviation Management.

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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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CRO Collaboration

The last few years have seen tremendous consolidation in both the pharmaceutical and contract research industries. The impact among pharma companies has created a heightened demand for productivity. 

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Remote Image Analysis

Imaging data in diagnostics and research is growing at an unprecedented rate, coming from all kinds of sources. The con-focal and high-resolution microscopy, artificial intelligence, and any other new computer-tomographic (CT) technologies create vast amount of data. When researchers start to collaborate over distances with imaging centers, using diagnostic services over internet connections, the bandwidth and computation power easily exceeds the capabilities in remote areas. 

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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).

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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.

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Raw Data Management

A clear understanding of how RAW DATA is defined, recorded, and retained in the laboratory record is essential when it comes to compliance with the Good Laboratory Practices regulations. RAW DATA in laboratories occur in various fluctuating formats and versions in a large amount of laboratory devices, LIMS and quality management systems. 

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Training Management

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

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eTMF and Archiving
To comply with regulatory government policies, clinical research organizations need to keep records of essential documents that are stored in the trial master files (TMF). The TMF allows independent auditors and regulatory authorities to monitor and evaluate the quality of the data produced by a clinical study.
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COMPLETE FLEXIBILITY TO BRIDGE THE ENTIRE PROCESS END-TO-END

Various flexible Add-ons emphasize fully flexibility, collaboration and compliance to bridge the entire process end-to-end

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flexible-Add-ons

iRAW


intelligent raw data archiving watcher
Processes, Documents, RAW Data, GxP Lab, Controls, SEND, loT

WATCH+

ARC+
IMAGE+

BYOD+
REPORT+

As well as all other Add-ons ...

iPQM


intelligent pharma quality management
Processes, Documents, QMS, qDMS, CAPA, Image QC, Issue Management

REPORT+

COMPLY+
SIGN+
IMAGE+
BYOD+
BRAIN+
TRAIN+

As well as all other Add-ons ...

iTMF


intelligent trial master file
Processes, Documents, DIA eTMF, CRO Migration, Longterm Archiving

ARC+

BRAIN+
REPORT+
SIGN+
TRAIN+
COMPLY+
MIGRATE+

As well as all other Add-ons ...

iRCS


intelligent regulated content services
Processes, Documents, rDMS, RIM robot, IDMP/SPOR, promo mats

COMPLY+

WATCH+
ARC+
REPORT+
BRAIN+
SIGN+
TRAIN+

As well as all other Add-ons ...

iARQ


intelligent and quality conscious archiving solution
R&D, Clinical Data, Non-Clinical, Quality Docs, SDTM, SEND

ARC+

WATCH+
IMAGE+
REPORT+
BRAIN+

As well as all other Add-ons ...

RESOURCES

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