Earlier in the year, representatives from Formpipe Life Science ventured to Brighton, UK, for the Health Sciences Records & Archives Association’s (HSRAA) Annual Conference. Bringing together experts on data archiving and preservation, the format of the day was informal yet educational; an opportunity to network with peers and share best practice. The workshops, presentations, and seminars set the tone for what’s likely to be a transformational next twelve months for organisations in the health and life sciences sectors looking to store, protect and preserve crucial business documents and data.

The event provided fascinating insight into the application of archiving tools across multiple sectors. It was clear however, that life science remains the benchmark for other industries to hang their hats – the gold standard to aspire to in terms of not just archiving data in a compliant, intuitive repository but preserving it too.

Digital archiving – or record retention -  remains a young industry; one that is still in many ways finding its feet. Despite drivers like GDPR and the need for increased security, following recent high-profile ransomware demands that have cost the life science sector millions, obtaining buy-in from the boardroom remains a challenge. Yet this needs to be seen as an opportunity, not just an obstacle. By defining a structured approach, promoting instances of best practice from companies like BlueEarth Diagnostics and Daiichi Sankyo, and by educating the c-suite – as well as the boots on the ground – we can get the message heard: digital document preservation is essential for ongoing commercial success.

There were several other take-aways from the day. Here’s a snapshot:

Is the file available and is it readable?

The first question the Medicines and Health products Regulatory Agency (MHRA) will ask during an audit of archive documents is ‘have you got all the files?’ and ‘can you prove it?’. Indeed it seems a common occurrence for material to be returned to the sponsor organisation in an unreadable state, due to the electronic format of the document no longer being supported.

Are we making things harder for ourselves by not utilising electronic systems?

The MHRA also pointed out that there remains a general lack of access to electronic archive safe repositories. An additional headache relating to this surrounds the lack of governance by a quality management system for electronic processes. This often results in a lot of different passwords, locations, and a network of very complex and disjointed systems. Often resulting in over reliance on individual skillsets within the IT team.

Are people handling archive data compliantly?

Recalling some common mishandling of archive material, a group discussion resulted in a common risk being identified. Following a request for retrieval of archived files, the person who made the request will often store the file on their own device in case it is needed by a colleague in the future; violating the original archiving procedure and potential confidentiality rules, while introducing significant compliance risk.

Pulling the past into the present: keeping it safe for the future

Many organisations have little or no plan for data being held on a system from 2010 or before – Systems are kept live and maintained to ensure access is available but this cannot continue forever. The delay in addressing the issue has compounded the complication in resolving it. Getting on top of documents from decades past and storing them compliantly so they can be reviewed now and preserved for the future needs to be addressed with a sense of urgency, especially taking into account recent legislation such as GDPR that will drive more requests of a historic nature.

What’s the migration process?

One key challenge many organisations seem to have with the concept of document archiving is managing the migration process: getting documents from a series of systems and formats, collating them, recording them and migrating them into a centralised archiving system. The processes often aren’t robustly designed and remain operational without validation. There is still a knowledge gap and lack of best practice in this area.

Scanning introduces risk

Scanning may seem like an innocent, risk free process to facilitate appropriate document archiving but in truth it can pose significant risk. Findings often flagged by auditors relate to companies that tidy up the electronic file copies for aesthetic reasons and in doing so create something that doesn’t represent a true copy.

Blur the lines of IT and Quality

A final thought relates to restoring legacy data – a task that’s often left to the IT department to manage in isolation. Without input and leadership from Quality personnel it’s hard for IT to appreciate the necessity in all file types needing the proof of Data Integrity, whilst ensuring files are readable.

Like what you’ve read? Want to learn more about how migrating legacy systems can improve efficiency, while reducing both the compliance risk and costs associated with data archiving? Check out HSRAA’s next issue of OnRecord magazine for more expert tips and guidance from Formpipe Life Science.