Over the last 20 years, one of the most significant changes in the management of data in the life sciences has been an increase in trust in digitally stored data. The evolution and heightened focus on quality within pharma has filtered through from addressing the product, where stringent demands are placed on manufacturing processes, storage and logistics, to the information and data that accompanies each product.

Ensuring that data is created, stored, and communicated securely and effectively is now just as important as manufacturing.

Complementing and reinforcing this trust is a robust data standards sector where compliance officers, standards for data management and storage such as ISO 9001 and the rise of standards agencies (GS1, The Institute of Electrical and Electronics Engineers) have become prominent.

More recently, there’s been a leap forward in processing capabilities which has allowed businesses to collect and manage additional data and various file types seamlessly. This has created opportunities to perform predictive analytics on large datasets, improve supply planning and resource management. With this come challenges around cybersecurity and the ethics surrounding the storage of personal data and data ownership. Regulations like the Health Insurance Portability and Accountability Act (HIPAA) and General Data Protection Regulation (GDPR) have been introduced to protect patient data, and some organizations have moved towards decentralized storage of data to prevent a single source of failure which could compromise integrity.  

Regulations including GDPR, HIPAA, GxP, the FDA’s Title 21 CFR Part 11 and the Falsified Medicines Directive (FMD) have created the necessity for the digitization of data and file management, creating a single source of truth whilst ensuring auditability and integrity.

These regulations and others have driven organizations to be able to produce data quicker when requested. They have also facilitated an environment where trust is granted between organizations when outsourcing non-core functions, thus allowing companies to focus on core business operations.

However, current regulations do not go far enough. We are still sharing sensitive quality documentation such as packaging artwork, which can be replicated and counterfeited, over email. When there are regulations that exist purely to protect patients, the industry needs to ask why it is still acceptable to send highly sensitive files through unsecure and non-collaborative channels like email? And why is it okay to work with suppliers and partners using non GxP validated tools like Excel where there are version control measures in place? Should this be the next big thing that regulators target with serialization now over the line?

In terms of supply chain trends, silos have been broken down over the last 20 years, but the supply chain is still fragmented. With more pharma companies outsourcing their manufacturing and packaging, the pace of change should increase and lead to greater visibility and collaboration, but only if modern platforms and technologies are adopted. The pace will increase due to heightened pressure to reduce capex, have greater speed to market, and because of a more competitive landscape amongst the CMOs and CPOs.

Technology and GxP validated platforms that enable better visibility, efficiency and collaboration do currently exist for the industry and we’ll see an exponential rate of uptake of these solutions in the coming years. However, the pervading concerns around implementation of new systems, training, and resource allocation will remain. To combat this, companies should select systems which can be seamlessly integrated out of the box into various business processes without causing interruption.

As for technologies and/or processes that have become obsolete in the last 20 years, historically, document management systems were highly customized for each installation and have been exposed as inflexible and often incapable of managing multiple processes in line with business needs. More recently, there’s been a move away from on-premise software to software as a service (SaaS) platforms underpinned by the industry’s adoption of cloud-based technologies. This decreases capex, and creates a lower barrier to entry for innovative software providers to make an impact and push the industry forward.