Archiving and validation: leading with digital in Life Sciences

Accessible, usable, leverage 

Digital transformation is top of mind for nearly every industry. Businesses face a multitude of challenges – from how to effectively accelerate and improve critical processes to how to best ensure the integrity and usability of the data they generate. The life sciences industry is no exception. 

With industry-wide adoption of Software as a Service (SaaS) cloud systems, digital transformation is a key business driver today, improving efficiency at scale unlike ever before.  

While certain segments of the industry are embracing this transformation – AI is being increasingly implemented into daily healthcare processes and solving new challenges for practitioners – other areas remain stubbornly slow to adapt, not least in the areas of archiving, preservation, validation, and compliance.  

For years, both archival and validation processes have relied on traditional methods of ink and paper tracking and monitoring. From what we’ve seen, even today 80% of life sciences companies are still using 1997 technology for Computer Systems Validation (CSV).  

Technology can minimize the opportunity for risk or human error, break down silos of information, and simplify the steps to manage evolving regulations and policy. It is critical for the industry to transform lagging, outdated systems.  

Leading by example: patient safety and security 

Life sciences is one of the most heavily regulated industries.  

Picture a familiar over-the-counter medication, for example. Before that medicine ends up in the hands of consumers, pharmacists or physicians, it’s subject to rigorous processes of research, testing, data collection, and much more.  

At the beginning of that journey, clinical trials are an integral step in the development and discovery of new medicine.  Each step throughout the trial is thoroughly documented and reviewed to assess outcomes and validate results.  

In addition to the actual testing and experimentation that takes place during research, there are processes and back-end systems of documentation (including archiving and validation) to ensure all products are fit for intended use, quality, and patient health and safety. While these processes are invisible to many, they play a crucial role in the broader journey of life sciences research and discovery.  

It is essential that these processes are operating in the most efficient and seamless way possible. Despite the weight of these processes and the sheer volume of data, many organizations are still using paper-based management processes.  

Simply put, this is unacceptable in 2022. It’s clear that a digital-driven process can solve challenges that many life sciences organizations continue to face today.  

Digital data: the future of cloud 

Legacy systems create a cascade of “tech debt” and many companies limp along on outdated systems – sometimes heavily patched between new and old – exacerbating existing challenges and slowing innovation.  

Fortunately, the cloud computing industry worldwide is set to reach a value of $397 billion by the end of 2022, with SaaS accounting for over $145.3 billion.

About 73% of the life sciences industry utilizes SaaS, and by 2023, that number is expected to rise to about 86%. The potential for companies to replace their legacy systems is incredible.  

As more organizations and teams transition to digital-first and cloud-based solutions, increased opportunities for the exchange and transfer of data, insights, and intelligence abounds. Not only is this critical to storing and tracking information more efficiently, but it also saves time, team resources and spend.  

Even more importantly, transitioning to digital-first and technology-enabled solutions is key in being able to maintain data integrity across life sciences, the advancement of the industry and the future of healthcare.  

Collaborating for success: a partnership between Arkivum and BTR 

BTR and Arkivum are on a shared mission: to support customers in transitioning to more efficient, digital solutions to transform the broader industry.  

Arkivum seeks to change how the world is archiving heavily regulated clinical data and ensuring that these valuable digital assets are accessible and usable for years into the future. BTR partners with companies like Arkivum to make sure the most modern and efficient ways are being used to ensure the compliance of their systems.  

Together, BTR and Arkivum offer customers a solution that achieves archival goals and reduces the validation efforts by more than 80%.   

Cautious life sciences leaders who are hesitant about a process overhaul have never had better options to quell their fears. Digital transformation across the life sciences industry is inevitable.

Companies that embrace tech-enabled solutions today will put themselves on a path to long-term success – and most importantly, improve patients’ lives.