Ben Saxton & Colin Swift from Formpipe Life Science recently attended the Scientific Archivists Group annual conference in Manchester. The gathering of industry heavyweights was made up of a series of presentations, each designed to offer delegates the latest insights into data integrity and preservation in the pharmaceutical sector.

Perhaps, one of the most interesting statements of the day, was the claim made by the first speaker, Martin Reed of the MHRA, who suggested that the value of metadata is often overlooked by organisations. He also raised the conundrum of recording raw data to mitigate the risk of data being incorrectly specified, and to ensure absolute trust. Referencing an example of results being copied from an instrument, rather than the original results recorded by the instrument being automatically fed to a computerised system. So how can this be achieved? How do our systems support this? Can our quality and archiving systems receive data in this format?  

Later in his presentation, Martin explored the common data integrity errors and pointed to poorly designed systems – citing access controls as key weaknesses, along with corporate behaviours and cultures that inadvertently incentivise users to misbehave. Poor review and checking – and attention to detail - were also mentioned as key risk factors. No surprises there but another key point made by Martin was how useful audit trails (and the ability to export them) are in demonstrating compliance during inspections, yet how challenging it still is for many when it comes to successfully preserving audit trial data.  

Another key theme covered by several talks, including one made by Oliver Herrmann of Q-Finity, was the urgent need for us all to embrace digital data preservation before it’s too late. In the age of big data, how to preserve electronic records, and help scientists relinquish theirs, is a key concern. Formpipe were encouraged to hear this point as Long Term Archive would support just this type of activity

Taking these topics by the horns, senior figures Anita Paul & Regina Woellner  from Roche provided a fascinating exploration of a recent initiative which addressed these issues from both a corporate and cultural perspective. In their presentations they gave an honest and interesting overview of the project and how they increased awareness of user activity when it came to data preservation and data security embracing human activity alongside great systems.

Looking at the issue of data preservation against the context of the public sector, Birmingham University’s Cancer Research UK Clinical Trials Unit (CRCTU) presentation addressed the challenge of raising the profile of data archiving to management. Cara Lax-Williams also provided insight into how the organisation champions compliance and data preservation best practice, whilst working within the confines of reduced budgets, reluctant user uptake of new systems, processes and procedures, and juggling multiple roles and responsibilities.  Cara made the interesting point that the word archivist doesn’t actually appear in her job description, an experience that was reciprocated within the room.

Leading on from this, Hugh O’Neil from Croft Data ran through the potential for a hybrid of possibilities resulting from the enhanced use of PDF in record retention, with new technology enabling users to allow inclusion of original documents as attachments. A white paper has also been published by the Scientific Archivists Group, contact the group to access this material.

Culminating with a discussion on the looming General Data Protection Regulation legislation, which will come into force in May 2018 and replace the existing Data Protection Directive 95/46/EC, delegates listened intently to a presentation by Act Now Training’s Ibrahim Hassan. Running through the core amends to the legislation, specifically in relation to extra territorial scope, changes in penalties -  which will be set at 2 per cent of global annual turnover for failure to have records in order - and more robust consent protocols.

A reoccurring theme of the day was the need to put more robust measures in place to protect and preserve data, promote enhanced operational efficiency and compliance best practice, confirming Long Term Archive is well positioned to support the Scientific Archivist function going forward.