Data you can’t access is data you don’t have. If your files are stored on old or obsolete hardware, like legacy servers, tapes, or proprietary eTMF exports, the problem is access. The files might still exist, but without the right device or drive, you simply can’t open them. Wait too long, and the media can degrade, making recovery impossible.

Readable today doesn’t guarantee readable tomorrow. If your files were created and the software is now obsolete, like old statistical tools or discontinued office programs, the problem is readability. You might be able to access the storage, but the software needed to open or understand the files no longer works. In many cases, converting them later may be too late to preserve the original content.

Lost context means lost integrity. When systems are changed or data is moved, important details can be lost. If metadata, audit trails, or links between records are not kept, trial records and data may become incomplete. This can make the records difficult to defend during an inspection.

Long-term access needs independence from suppliers. If you cannot fully extract your records from a system, you may become dependent on the vendor. Changes in pricing, system upgrades, contract terms, company ownership, or even supplier failure can put long-term access to trial records at risk. Lock-in is a reality for many organisation when live systems are used for long-term retention.

When ownership shifts, accountability can break. Mergers, acquisitions and system retirements can create ownership gaps, broken chains of custody and undocumented transfers of responsibility.