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Long Term Archiving for Regulatory Compliance
In today’s highly regulated life sciences world, regulatory terms such as eCTD, ASPPs, CANDA, SPL, MAA and NDA have become the norm. Companies seeking to be successful must comply with every intricate detail with clinical trials and registrations, thus making it a difficult endeavor for organizations to keep up. This is when archiving steps in to become a critical part of any company's records management strategy.
Long-Term Data Retention and Archiving Strategies for Regulatory Compliance
Being a researcher, it is critical to be aware of the importance of having a comprehensive archiving and retention plan in place to ensure compliance with the laws and regulations governing the relevant industry. Without such a plan, organizations can be subject to hefty penalties and fines. A well-crafted archiving and retention plan is essential to ensure that organizations consistently comply with the applicable standards and regulations.
Archiving, by using the neuronOS platform, is the process of securely storing inactive information policies and data, including labels and monographs, in any format for future reference or regulatory compliance.
So why is archiving so important? Archiving provides an organization with the documentation, explanation, and justification for both past and current actions. This is particularly important to companies in highly regulated industries, such as life science, where accuracy and precision are crucial. Here, archiving can be used to better track, manage, and access documents throughout their lifecycle, ensuring that information is stored securely and efficiently to stay compliant.
Regulatory Business Process Management
Exploring the repercussions of archiving is essential for research professionals in the life sciences industry. Not only is archiving critical for meeting regulatory requirements, but also it is a great way to promote the data security of an organization, by helping to reduce potential conflicts, enhance transparency, and remain complaint but fast-moving regulatory demands.
At biomedion, neuronOS provides a more sophisticated level of archiving controls for regulatory submissions. With our innovative platform, we enable organizations to securely and efficiently store and manage documents, as well as easily access past files for reference. Our platform helps organizations store large amounts of historical data safely, in addition to quickly retrieving highly-detailed documents that support label and submission lifecycle activities.
We are proud to provide a comprehensive archiving solution that accelerates regulatory submissions compliance in the life sciences industry. neuronOS provides the ideal solution for researcher looking for the best way to ensure the compliance of their records - the ability to securely store, track, and access the information quickly and easily.
With archiving being such a critical component of any successful life science company, it is essential to learn more about how this process works and how it can be incorporated into your existing records management strategy. By doing so, you will ensure your compliance within the regulatory environment and ensure long-term success.
biomedion started with the first ever cloud-based eDMS system designed for life sciences in 2005. We enhanced these tools with the addition of eCTD Regulatory Submission Management along with full Virtual Data Room capabilities. Now neuronOS provides the only Azure based Clinical eTMF and ISF with full eDMS capabilities.
And neuronOS eMPM supports end-to-end Promotional Materials Management for Medical, Legal, and Regulatory review and approval. Combined with Clireo eCTD and the new Module 1 for the FDA eCTD, Clireo creates the industries only integrated Promotional Materials Management system with integrated eSubmissions capabilities.
"The only way in which to treat the elements of an exact and rigorous science is to apply to them all the rigor and exactness possible."
Jean Le Rond D'Alembert | Mathematician and Physicist
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