How can a digital archive protect data integrity?

One of the easiest and seamless ways to ensure the longevity of your data’s integrity is by safeguarding it within a digital archive with preservation capabilities. I’ve outlined below some of the top reasons as to why this is.  

1. Data will remain readable and usable 

Your digital content will remain readable for the duration it is archived. The digital preservation aspect of an archive carries out automatic processes to the data whereby a copy of each original digital asset is created and maintained in a format that can be opened and read by future hardware and software. Most importantly, it also does not matter whether the data uploaded has been digitised or was born digital.  

So, whatever has been uploaded will remain in a readable and usable format… forever. 

File format obsolescence becomes a worry of the past.  

2. An easily searchable archive  

While ensuring that your long-term data is safe, accessible and usable, it is largely useless unless you can also easily search and find the files that you need. 

Within the eTMF and clinical trial data there are a broad range of requirements that could see stakeholders needing to find specific data from a trial many years after it was originally created. It’s also possible that an inspector may want to see information on a trial as part of an audit, or certain trial data needs to be accessed for the repurposing of an existing drug. 

A well-prepared archive will use metadata to ensure that the large datasets generated during the clinical trial process can be easily searched after the fact. 

Not sure what metadata is? It’s essentially additional information about the data or file that you have. A simple example of metadata would be the date it was created, or last date it was modified.  

By attributing appropriate, consistent and detailed metadata to each file going into the archive, it ensures that specific files can easily be found long into the future.  

3. Regulatory compliance requirements  

Aside from following good data practices such as ALCOA, clinical data is also impacted by various regulations and governing bodies (of which there is more information about on our blog). 

One of the top requirements include the use of time-stamped audit trails to monitor and track all access and amendments made to the archived records, as reflected in the ALCOA principle, contemporaneous.  

As you work further through the rules and regulations which affect you (depending on where your organisation resides and where the drug will be marketed), you can begin to see how following data best practice principles can help you on your journey to compliance.  

4. Controlled access  

As reflected in the ‘accurate’ principle of the ALCOA best practices, a digital archive and preservation solution can help protect and ensure data integrity by limiting access to the archived data.  

This retained data is protected by limiting access to the records so that only those who need permission can do so.  

Complimenting this benefit of accessibility is the safeguarding of your data, especially that of data immutability whereby, once assets have been uploaded into the archive, they cannot be amended or tampered with…by anyone. Permitted users can access and download them, but they cannot alter them. 

These benefits are only possible when storing clinical data in a digital archive and preservation solution – not within alternate storage options or backups.   

Safeguard and protect your data for the future 

The integrity and therefore, reliability, validity and trustworthiness of your data will become safeguarded and protected against: 

• Data loss 
• Data corruption 
• Software applications and operating systems becoming obsolete 
• Hardware failure 
• …and more.  

In summary, digitally archiving and preserving your assets will ensure they remain: 

Attributable  

Legible 

Contemporaneous 

Original  

Accurate 

Keen to learn more? Book a demo with our team of experts today.