New HSRAA white paper on Long Term Digital Preservation of GxP Health and Life Sciences Data

The HSRAA have published a new white paper on Long Term Digital Preservation of GxP Health and Life Sciences Data. I was very pleased to be invited by the HSRAA to lead the white paper and use it to share knowledge, experience and resources on digital preservation with the HSRAA community.

For those not familiar with the HSRAA (Health Sciences Records and Archiving Association), to quote their website, they are a “reputable, global, non-profit, member-driven professional association … that offers stakeholders in the life sciences and healthcare sectors a trusted community and forum for collaborating, learning, and sharing knowledge, industry standards, and best practices for Information Governance, Records Management, Archive Management, and Digital Preservation for regulated and research records that are subject to regulatory inspection.”

Or more simply put, the HSRAA supports a really friendly and collaborative group of like-minded folk who work together to address the challenges of long-term GxP records retention and archiving.

I’ve been fortunate to work with the HSRAA for many years now and it was great to be asked to write a white paper that pulls together digital preservation knowledge that I’ve been sharing with the HSRAA community at conferences and events.

The white paper covers a wide range of topics.  Just some of these include:

• An overview of the regulations and guidelines for GxP retention and archiving;
• Taking a risk-based approach to long-term Data Integrity;
• The application of digital preservation good practice to areas such as business cases, people and skills, procurement of solutions, long term storage, file format risks, the use of standards, digital preservation strategies and more; and
• How digital preservation can be folded into a GxP environment including requirements specifications, supplier qualification, computerised systems validation and oversight.

One thing I was particularly keen to do in the white paper was provide plenty of references and signposts to the great work done in the digital preservation community, including guidelines and good practice from organisations such as the Digital Preservation Coalition (DPC) and the National Digital Stewardship Alliance (NDSA).  In particular, I’ve focussed on how these can be applied in a GxP setting, for example enabling organisations to achieve long term Data Integrity in a way that meets the regulations.

There are so many great digital preservation resources out there that can be applied in regulated health and life sciences settings – but only if people know where to look and how to use them!  That’s what this white paper aims to address.

The white paper is currently only available to HSRAA members, but membership is only £60 a year.  Membership provides access to the white paper and many other resources and benefits; if you aren’t a member, then I’d have no hesitation in recommending that you join.