F.A.I.R.

BEST PRACTICE

Good Documentation Practice: ALCOA - ALCOA+ - CCEA - OAIS

best-practice

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GOOD DOCUMENTATION PRACTICES

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biomedions neuronOS ecosystem spans the entire drug lifecycle from discovery and research, through development and regulatory compliance towards customer trust and satisfaction, whilst continually leveraging technology and innovation.

neuronOS as innovative future-proof SaaS platform for the digitization of the life-sciences life cycle proactively reduces regulatory vulnerabilities ​for businesses and offers best practice ready to go solutions to create value along the life science processes.

 

ALCOA / ALCOA+

Attributable​ - All paper and electronic data must be attributable to the person generating the data including who performed an action and when. Attributable can be accomplished by recording manually by initialing and dating a paper record or by audit trail in an electronic system.
Legible​ - All paper and electronic data must be legible and permanent. Ensuring records are legible and permanent assists with its accessibility throughout the data lifecycle including the storage of paper and electronic data.​
Contemporaneous​ - Contemporaneous means to record the paper or electronic data at the time it is performed. Date and time stamps should flow in order of execution for the data to be credible. Data should never be backdated, or forms completed with expected results prior to execution.​
Original​​ - Original data is the paper or electronic medium in which the data point is initially recorded including protocol, form, notebooks, spreadsheet, database, or software application. Understanding where the original data is generated to ensure content and meaning are preserved.​​
Accurate​​ - For paper and electronic data to be accurate, the data should be free from errors, complete, truthful, and reflective of the observation. Editing should only be performed by using the principles of GDPs.​​

CCEA

Complete​​ - All paper and electronic data including original test results and repeat test results must be properly recorded clearly identifying the person performing the test as well as when the test was performed.
Consistent​​ - The data’s sequence of events should be in the expected sequence of operations and appropriately date or time stamped to demonstrate the data are contemporaneous.​​
Enduring​​ - Paper and electronic data are appropriately recorded in laboratory notebooks or invalidated software systems including spreadsheets and databases.​​
Available​​ - Paper and electronic data are required to be readily available for review, audits, or inspections for the required lifetime of the record. Paper and electronic data should be clearly indexed and/or appropriately labeled to facilitate retrieval.​​

OAIS

OAIS The Reference Model for an Open Archival Information System (OAIS) was developed for use in facilitating a broad, discipline independent, consensus on the requirements for an archive or repository to provide long-term, preservation of digital information. It was also intended to support the development of additional digital preservation standa

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 ...

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.

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FINDABLE

Be able to find your data! By using rich metadata and keywords you can run your system appropriately with a searchable resource.


ACCESSIBLE

Use standardized communication protocols especially in the scientific industry and authorize the right people.


INTEROPERABLE

Use a formal, accessible, shares and broadly applicable language for knowledge representation.


REUSABLE

Reusability is the one of the most critical things. Use a plurality of acccurate and relevant attributes and make the data available to use!

TOUCH

For QA's

For QA's

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.

 

TOUCH

For Scientists

For Scientists

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

 

TOUCH

For IT

For IT

Low Code

Allotrope data Connector

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