Given the nature of its products and its customers, it follows that the life sciences sector is highly-regulated. In fact, the term “pharmaceutical”, per its Greek etymology, “pharmakon”, means both care and poison. Hence, before being marketed, pharmaceutical drug products must pass an abundance of different tests and be subject to extensive rules and regulations in order to guarantee safety for its customers and patients.

This is not a linear path. The life of the pharmaceutical drug product begins with its discovery, but it doesn’t end with its immediate and quick distribution to those who need it most. From the moment of the initial conception, the path that it follows can be fragmented across different centres, universities and other educational institutes and even across different pharmaceutical companies. This fragmented path results in a vast amount of data production and data sources with complex data property, data custody and data management rights and requirements as well as various data media types. These complexities, coupled with the difficulties associated with identifying and controlling data that requires long-term management and maintenance, represent a significant challenge for pharmaceutical companies today.

FDA (Food and Drug Administration) and European regulations prescribe requirements for data retention and data production, for example the requirement to retain relevant data up to several generations of software and hardware. Another requirement relates to the retention of pharmaceutical drug product registration-related documentation for as long as a product is on the market plus 10-15 years. A typical registration submission for a pharmaceutical drug product to a Health Authority consists of a large amount of paper scanned to PDF format, generated from and / or summarising some of the source data.

According to Anita Paul (Roche, Basel, Switzerland); Juerg Hagmann (Novartis, Basel, Switzerland) today the future of pharmaceutical drug product registration is gradually becoming paperless and, very soon, paper submissions will no longer be accepted by major Health Authorities. But is the life science sector moving quickly enough in the same direction? The two scholars discussed the challenges of digital preservation, which does not just mean the ability to read specific data in preserved (rendition) format but also means the ability to “readily retrieve” all pertinent raw data and metadata.

Digitisation of data is arguably the most effective way to preserve the data content and context, and also to facilitate access and retrievability as required. Building digitisation of data in at every step along the fragmented path of a pharmaceutical drug product results in easy access and retrieval of accurate data by the right people which contributes to sound quality decisions and ultimately safer products for patients.

So, the question is, how can we embrace this digitisation of data to ensure that vital and essential data is preserved and accessible for as long as it needs to be while protecting its integrity?

Bibliography

Anita Paul (Roche, Basel, Switzerland); Juerg Hagmann (Novartis, Basel, Switzerland), Challenges of Long-Term Archiving in the Pharmaceutical Industry, 2008 http://www.imaging.org/site/PDFS/Reporter/Articles/Rep23_5_NIPDF2008_PAUL.pdf (last access 09/09/2019)