Digital Storage vs. Digital Preservation
Immediately ignoring the “archiving” of data to portable media such as DVD or flash drives, it is not uncommon to find that laboratory data is “archived” by being left dormant on the system or equipment upon which it was originally generated, analysed and processed.
In these situations it is rarely (if ever) the case that consideration is given to actively managing or protecting the data for the long-term to ensure its long-term availability*. Though not ideal, this approach to “archiving” may be useful for situations in which it is difficult or costly to migrate data (especially analytical data) and its associated metadata and audit trails The data and associated metadata and audit trails need to remain intact and available to ensure data integrity for evidential purposes e.g. for marketing applications or during future inspections.
This is especially true for data created, generated, analysed, and processed (in laboratory settings) on test execution systems such as mass spectrometers, chromatographs etc.
Or even, on interfacing management systems such as electronic Laboratory Notebooks (eLN), Enterprise Resource Planning Systems (ERP) etc, and (in clinical environments) on wearable devices, smart phone apps, ingestibles, biomechanical devices etc.
However, leaving data “in situ” presents potential challenges by:
- Placing data at risk of loss through obsolescence, degradation, unintended deletion or modification.
- Reducing inspection readiness.
- Reducing regulatory compliance.
- Expensive “tie-ins” to hardware and/or software vendors.
To comply with regulatory requirements, archived laboratory data must be subject to restricted access and come under the control of the archivist.2
Accordingly, any data retained in this way should be separated physically (e.g. in a dedicated folder) or logically (e.g. via access permissions) so that there is a clear distinction between data that is “live” and data that is “archived”.
The “leave data in situ” strategy does little, to:
- Protect data from untimely deterioration3.
- Actively and continuously preserve the integrity of archived laboratory data4.
- Automate (if required) retention of data in both native and preservation formats5.
- Provide sufficient metadata for focussed discovery and effective retention management.
To fulfill regulatory requirements, it is best practice to consider the use of a purpose-built digital preservation solution.
Figure 1. A visualisation of the separation of ‘live’ and ‘archived’ data.
*Whilst portable media can be useful as a transfer medium, they are not suited as an archive medium for GLP data because:
- Their life expectancy is hugely variable: accelerated tests have demonstrated potential failure sometimes within a 5-year period or less.
- They are prone to physical loss and damage.
- “Bit-rot” (deterioration and degradation) can render the media and data inaccessible and unreadable.
- Format obsolescence.
- The device connections needed to read portable media may no longer be available e.g. many laptops today have no floppy drive, DVD drive, or even USB-A ports.
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