Intelligent raw data archiving
The necessity for end-to-end compliance and data integrity drives solutions towards decentralization. The traditionally centralized corporate service- and business logics are at best a repository of interfaces and configurations but lack to know all operational logics and business workflows in a local laboratory. As a result, we still see a growing number of inspection findings in the category data integrity.
VERSATILE AND DATA DRIVEN PLATFORM
Connect the Dots in Life Science and Improve Excellence in Pharmaceutical Development Processes
Time to Market
The disruptive shift in Biopharmaceutical landscape due to even more decentralization, the trend towards biologicals and the expected shorter development times for medicinal products (after Covid-19) lead to a new demand in the life sciences industry: The need for modular, more versatile and data driven platforms.
Existing and legacy solutions lack connectivity, are partly redundant, and dispersed and handled separately and disjointly by often disconnected staff members. Important decisions are based on what local staff can oversee. Important data is still shared via email and stored redundantly in excel spreadsheets or SharePoint across the corporations or even only in local or regional departments.
This manner of storage often leads to hardships with regards to how the data was managed, updated, and shared; when data needs to be updated, all copies must be updated manually with great care so that out-of-date information is not kept and recirculated through defined processes.
With neuronOS and the integrated FAIR principles on platform level, customers may overcome problems or findings related to missing consistency and data integrity in a systemic fashion.
The neuronOS approach is the service-based or service-oriented architecture, at its essence. With this change in paradigm – away from tightly coupled applications that focus on the user interface – neuronOS as a platform rather exposes the underlying business functions as connected services which can leverage complexity in nearly every process landscape in the life science industry.
Users in their roles can start using the platform after role assignment and limited training-effort. The platform will set some access rules and security roles which users will need to follow. The platform has several modules, data models and add-ons that are interdependent, thus a careful implementation plan with process review is recommended.
Keep archived data accessible for audits and inspections
Businesses grow and while doing so, they will create more data – data that needs to be meticulously managed, monitored and utilized properly.
Archiving and e-archiving is vitally important for a complete information lifecycle but also helps to fulfill regulatory requirements and process compliance.
The challenge for an e-archive is no longer just to get the required information into an actual archive – but rather keeping archived data accessible for audits and inspections, all along with necessary quality measures and applicable corrective and preventive actions.
iARQ is ready for end-to-end data integrity and uncompromising inspection readiness at any stage of the life sciences lifecycle
neuronOS as innovative future-safe 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. Various Add-ons emphasize fully flexibility, collaboration, compliance and distributed architectures as a de-facto operating system to leverage innovation along the whole life sciences life cycle by using an agile configuration.
The concept of decentralized agents
By implementing rules encoded as computer programs (so called smart contracts) research organizations have a new way to solve this problem. In theory, any interaction between humans and organizations can be expressed as a contract. Smart contracts (information transmission and enforcement of contracts) these days built on Blockchain technology enable us to construct these kinds of organizations based on clouds and decentralized intelligent agents.
These decentralized intelligent agents execute their missions (services) that correspond to actual stages of approved cloud-based business workflows e.g., in neuronOS, carrying capabilities to ensure compliance, follow quality rules and regulations and to act as part of a defined and validated process.
Today's organizations can tie the loose ends between local processes and global oversight with neuronOS iRAW incl. WATCH+
- Aiming for data integrity across the life-cycle - end-to-end.
- Decentralization as part of globally distributed Processes
- Risk mitigation for unpredictable data growth
- Improved efficiency, flexibility, security of data processes