The benefits of a dedicated archiving and preservation environment: Cost, Compliance and Consolidation.

The benefits of using a single and consolidated archiving and preservation environment for GxP regulated data can be significant.  Costs are lower compared with trying to archive data across a set of live systems.  Compliance is much easier to achieve for long term Data Integrity under the regulatory GxP ALCOA+ principles. Consolidation of data into a single long-term repository makes it easier to find and reuse that data, which then makes it easier for an organisation to get the most value from its data.  GxP data is an asset that can be exploited and reused by the business and should not be treated only as a compliance liability!

Compliance: Regulation & ALCOA+ principles

Achieving long term GxP Data Integrity that follows the ALCOA+ principles for multi-decade timescales is a regulatory requirement, for example for TMF and Study Data under GCP.  This requires the use of Digital Preservation good practice.  In other words, Digital Preservation helps deliver long-term Compliance.  For example, digital preservation techniques can help ensure data is always Legible and Available so it can be opened and used whenever needed.  Digital preservation helps ensure data doesn’t get corrupted or lost, which means it remains Enduring and Complete.  The benefit of digital preservation is lower risks, successful inspections, and data that can be used to reconstruct the story of a trial to show that the results are trustworthy.

Costs: Managing finances effectively

Trying to archive and preserve data when it is distributed across live systems, for example in decentralised trials, can be really hard.  Using multiple live systems for archiving studies that are closed can be expensive, for example because you are paying for features that are no longer needed when a study is closed.  But more importantly, you have to spend extra effort in actively making sure you know where all your data is, that it can always be accessed and used, and that it is successfully migrated every time a live system becomes end of life and needs to be replaced.   In other words, using a dedicated environment that is designed for the sole purpose of archiving and preserving data can save Costs.

Consolidation: Reaping the benefits of a single archive

In a modern GxP data environment, there will be multiple types of data in a range of different systems and with different compliance and retention environments.  Consider a typical landscape of clinical data and records distributed across an EDC, CTMS, TMF, LMS and QMS.

Consolidating data into a single archive, for example for a Sponsor, makes it far easier to manage, for example when checking that it is complete, correct and accessible.  But more than that, consolidating data into a single archive environment makes it much more discoverable and reusable.  This allows an organisation to more easily extract value from its assets, for example when reusing previous research, when selling products or undergoing mergers and acquisitions, or when protecting and exploiting IPR.

Conclusion

The benefits of lower costs, better compliance, and getting value from consolidating assets are of course interconnected. Consolidation makes it easier to achieve compliance, for example inspection readiness by having data all in one place. Consolidation also reduces costs because there’s only one system to validate for archiving and it’s been designed from the outset for that specific purpose. Therefore, costs, compliance and consolidation can work in harmony and ensure that a business not only meets regulatory needs but gets the best return on investment and value from its data.