In recent years, the COVID-19 pandemic has dramatically accelerated the shift towards digital technologies within the pharmaceutical and life sciences industry. No more so can this be seen than in the use of eClinical systems.
While there have undoubtedly been huge benefits to this change, it has also created several new challenges.
Traditionally, many of the records generated were captured on paper and stored within physical archives. While this process in many cases will still remain, many of these records will also be digitised or increasingly born-digital – i.e. produced in digital form, rather than having been converted from print or analogue equivalents.
Retaining digital records for years, decades or even forever creates a unique set of challenges in order to avoid potential loss of data, corruption and file format obsolescence. A purpose-built digital preservation solution is required to guarantee the long-term access, discoverability and use of long-term records.
Our teams are often met with the same concerns and asked the same questions from our customers in regard to choosing an appropriate digital preservation system.
How should you go about selecting a digital preservation system? What are the key steps? Which stakeholders should you involve? What will it be used to preserve in the first place?
We’ve broken the process we advise down into 6 short and manageable steps to help ensure you select and onboard the digital preservation system that fits your organisation’s needs.
Step 1: Gather your key stakeholders and discover what your preservation requirements are
Firstly, you need to go through the process of getting your stakeholders (or a selection of them) and asking them:
- What’s important for us?
- What does it need to have?
- What are you trying to achieve with this archiving system?
If you are looking at asking a selection of your stakeholders, ensuring you’re targeting the various departments/areas of needs your preservation solution must meet will be crucial.
You may have stakeholders who are involved in QA, product, IT, suppliers/supply chain, subject matter experts and the end user (to name a few).
Step 2: Identify your user requirements
Secondly, assess what your user and functional requirements are for that system.
- Does it need to be validated? (This is essential if you work within a regulated market)
- Do you need to be able to track changes and amendments via complete audit trails?
- What reports will you need? Do you know the reports you’ll need?
- How secure will your data be?
- Will you be able to assign permission controls? Will you be to retract access permissions?
Step 3: Create a validation plan
Having a validation plan in place is essential in order to be able to refer back to the above-mentioned user requirements and keep track of progress.
- How will you test it?
- Who will be assigned which responsibilities?
- Will you have to regularly report back to stakeholders on the progress?
It’s crucial that you should incorporate testing within your validation plan. this should be tested against your functional and user requirements.
Step 4: Create evidence of testing
Create evidence of your testing and audit of your system supplier. This is so you can be confident that at all stages of the processes you have met the requirements you originally set, you’ve understood what you are trying to achieve and you understand what the outputs are going to be (rather than just focusing on the inputs).
Step 5: Audit the supplier
With the implementation of any system, you must consider and understand the outputs your organisation requires of the system, rather than solely focusing upon the inputs.
We have seen many times that the user and functional requirements of a preservation solution are only discussed after a system has been chosen and implemented.
This simple 6-step sequencing will provide you with the assurances that you have wisely chosen your preservation solution (and provider) and that you understand the needs and associated monitoring.
If you would like further information in regard to choosing a digital preservation solution, please contact us.
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