Long term data management for pharmaceuticals and life sciences organisations
Digital Data Preservation: The next big compliance hurdle no one knows is coming
Regulations require storage of eTMF and clinical data for retention periods as long as 25 years or the lifespan of the product. At the same time, this content must be stored according to ALCOA+ principles. With increasing amounts of distributed data, and an increasing number of systems and partners to manage, the ability to centralise and manage data for the long term is more challenging than ever.
You’re on top of your organisation’s compliance and regulatory requirements but do you have data preservation and long-term access of your data under control?
Arkivum Trust preserves your data for the long-term, maintaining compliance and regulation throughout and making sure it is accessible and reusable for as long as you need it
All pharmaceutical companies have a regulatory requirement to keep key GxP records (eTMF data, clinical study reports, lab notes etc) for the long term, in some cases indefinitely. During that time, it is mandated that regulatory authorities are able to have readable access to the archive for regulatory audit purposes and be able to reconstruct a clinical trial should there be a question about one of their products or trial processes years down the line.
Arkivum software and services makes your historical data an asset rather than a risk by removing data silos around your business to make data accessible and usable, guaranteeing 100% data integrity and preserving it for the long term.
The competitive nature of the industry combined with the need to innovate and reduce costs is driving an increased need to be able to collaborate better both within and across organisations. Arkivum Trust provides secure sharing of data and adherence to regulatory standards to deliver GxP compliant data. This aids easier data migration between organisations, and creates a single source of truth across your long-term data. By using Arkivum we can give you peace of mind through our fully managed service that you will be able to access, reuse and consolidate data from recently acquired assets, trials or compounds and old research, removing data silos and ensuring long term management of your regulated data.
Continuing to run systems once they have reached end of life is a very risky strategy, yet so many organisations do so. Not only does it mean a severe lack of security as you are often unable to plug decommissioned systems into your security policies and processes, it also means a lot of your valuable data is locked in to a system that could die at any point, which puts a lot of your research data at risk of loss, corruption and inaccessibility.
Arkivum software removes data silos and allows organisations to integrate valuable data, removing risk by making your data accessible usable and compliant for the long term.
Here's what our clients have to say about us
Dr Marco Loddo, Co-Founder and Scientific Director at Oncologica
20 May, 2019
Oncologica, a leading precision oncology profiling company and Contract Research Organization (CRO) in the pharmaceutical industry, has chosen Arkivum Trust, to provide an integrated long-term data management…
01 Apr, 2019
Just how difficult can it be to archive electronic data generated from a drug development project? Surely it is enough to create an “Archive” folder on a…
12 Dec, 2018
What do we mean by decommissioned systems and what are the challenges? Decommissioned systems have been a common fact of life in all technology, be it laboratory…
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12 Dec, 2018
What do we mean by decommissioned systems and what are the challenges? Decommissioned systems have been a common fact of life in all technology, be it laboratory…
06 Feb, 2019
It seems that Brexit has overtaken the weather as the most popular topic of conversation these days on the islands of Britain and Ireland, and no topic…
19 Nov, 2018
After initially becoming an Arkivum client last year to manage 10 TB of their long-term data, the University of Nottingham worked with us to expand the coverage…