Long-term digital archives: an accessible and accurate audit trail - Arkivum

Archiving & Preservation / 09 Dec, 2020

Long-term digital archives: an accessible and accurate audit trail

Long-term digital archives for an accessible and accurate audit trail

Every pharmaceutical and biotech company needs to have a robust approach and process for records management, long term archiving and preservation of data, to support compliance with key regulations.  The pharmaceutical supply chain is complex and when a pharmaceutical company relies on its partners—for example CDMOs and other suppliers—to store essential documents, it can lead to information silos that can be an obstacle during a regulatory audit.

As the industry continues its transition from paper to digital archives, it requires a robust electronic data validation process, including an electronic quality management system (eQMS), to ensure a complete audit trail throughout the drug development and manufacturing lifecycle.

Centralising data storage can streamline this process, meaning third party digital preservation partners are key to ensuring the right data storage infrastructure is in place. Selecting an experienced digital preservation partner can give companies greater confidence that their archived data is packaged in a format that is readily retrievable.

The right partner will have a complete long-term digital archiving strategy which uses a robust eQMS to gather data from all disparate and globally separate players in a central repository. This process offers digital integrity and GxP compliance, so the data is rapidly accessible and provides an accurate, readable, safe, and long-term audit trail.

Clinical trial data

In clinical trials, archiving critical data is the drug sponsor’s responsibility and pharmaceutical companies must ensure long-term storage for compliance with the EMA, the FDA, and other global regulatory requirements. One of the most impactful changes is the EMA’s recent change to Trial Master File requirements (TMF). In December 2018, the agency published guidelines[1] stipulating:

  • “Electronic TMFs (eTMFs) should enable appropriate security and reliability, ensuring that no loss, alteration or corruption of data and documents occur
  • Access to the TMF should be based on a role and permission description that is defined by the sponsor and/or investigator/institution
  • At all times the storage area for the TMF documents (such as paper or electronic media archives and server rooms) should be appropriate to maintain the documents in a manner that they remain complete and legible throughout the trial conduct and the required period of retention and can be made available to the competent authorities of the Member States, upon request
  • All staff members involved in the conduct of the trial and using the system should receive appropriate training
  • Metadata applied to documents should be formally defined to ensure consistency across all documents
  • After archiving any alteration to the content of the trial master file shall be traceable.”


One of the more vital changes was that “the eTMF systems should be validated to demonstrate that the functionality is fit for purpose, with formal procedures in place to manage this process.” The implications here are three-fold.

  1. The eTMF systems must be tailored to the industry’s needs – a generic document storage management and archival tool is not adequate.
  2. Validation is mandated and must be demonstrable with documentation
  3. The eTMF must be proactively managed and maintained – this is further emphasised by another of the requirements: The TMF including the audit trail (for eTMF) should be archived appropriately to enable supervision after the clinical trial has ended.

To achieve this, companies need a long-term storage and retrieval solution for their clinical trial data, drug development projects, and manufacturing processes that will ensure data is readily available whenever it’s required. This means a good data management system, that includes regular review of the integrity of all files in its archives, is essential.


Some guidance on how validation of these systems is to be undertaken is offered in the FDA’s 21 CFR Part 11, however it is non-prescriptive and does not offer detail on the specific validation elements that are applicable. The guidance states that validation consists of “confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled.”[2]

The European Union’s Eudralex Vol.4 Annex 11. offers much the same guidance adding that there must be controls in place that allow operators to identify when the system doesn’t function as per its intended use.

In short, validation protocols are at the discretion of trial sponsors but they must be adequate. This is where the value of pre-validated and automated validation is created. Outsourcing eTMF management and archival to a third-party that has these systems saves sponsors time and resources that would have been spent creating new processes against an unfamiliar and under-prescribed regulatory framework.

Insist on inspection-ready digital data archives

Arkivum provides validated digital archiving support and software for document tracking. Our experienced team is ready to protect your critical data and guarantee that it is accessible, secure, reliable, and immutable, now and in the future.

To learn more about how we deliver complete data integrity and data preservation for the long term, book a demo today.

[1] https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-content-management-archiving-clinical-trial-master-file-paper/electronic_en.pdf

[2] fda.gov/media/73141/download

Matthew Cooke

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