It’s a bit ironic but in the face of dramatic technological transformations that are reshaping the way life sciences manufacturers conduct business, including blockchain, artificial intelligence, machine learning, the internet of things (IoT), and a half dozen others, many life sciences organizations continue to rely on manual, paper-based data systems.
In a 2018 poll of life sciences and similarly regulated industries in which 244 companies responded, 62% said that their document control system was largely paper-based or a manual or hybrid system; 28% indicated their data system was partly automated and partially paper-based; and another 12% said their data system was automated but not fully integrated.1
By clinging to seemingly tried-and-true traditions and avoiding the undeniable benefits of digitization, however, organizations are racking up operational costs, increasing their risk levels, and impeding research progress.
The Dangers of Paper-Based Document Control
Before joining MasterControl, I worked at the U.S. Food and Drug Administration (FDA) and the U.S. Department of Veterans Affairs (VA). Both are massive organizations, with hundreds of locations and thousands of different standard operating procedures. At any given moment, any number of documents in our original paper-based system would be going through revisions. Attempting to determine who was working on a new document, who was making updates, which documents were being modified, and where any changes to data were being made was a monumental — and often flat out impossible — task.
Don’t Underestimate the Soft ROI of Going Paperless
The hard ROI of digitizing life sciences and health care document control systems is clear: By no longer needing to scan documents, store massive quantities of boxes, or accommodate the extra resources required to manage paper-based processes, organizations can drastically optimize their cost of production. Equally important, however, is recognizing the soft ROI of digitization, especially considering the current pace of innovation and an increasing penchant for transparency amongst inspectors and the FDA.
In particular, organizations should consider the following paperless document control benefits:
- Improved quality and process control for daily tasks.
- Streamlined viewing, exporting and reporting capabilities for auditory requirements.
- Widespread updates and accessibility across global locations.
- Role-based security and permissions for critical assets.
- Optimized employee resource allocation due to automation.
- Centralized data storage and the ability to cross-analyze multiple databases.
Perhaps the most invaluable benefit of going paperless is gaining the ability to confidently tell an inspector the story of what occurred throughout quality management, manufacturing production records or regulatory information management, how the risks were evaluated and how the production procedures were approved. If anything goes wrong during production, organizations can clearly explain what happened, when it happened and how they responded, thanks to the real-time visibility and data transparency of digital systems.
By implementing a digital document control system, life sciences organizations can confirm that every component in a process has been qualified and approved, training has been completed for all staff, validations have been signed for all equipment, and testing has been completed for all materials used. Paperless systems also enable organizations to easily document any changes to their manufacturing processes (should improvements need to be made or new equipment added) and reassess any accompanying risks.
Long-Term Relevance Requires Joining the War on Paper
Change is never easy. And for industries as established, vital and high-risk as life sciences and health care, breaking old habits and suddenly walking away from long-held practices is understandably difficult. Furthermore, continuous improvement practices have reliably demonstrated that small, incremental changes — not immediate, major paradigm shifts — ensure quality.
Even at the FDA, it took significant time and effort to go digital. In preparation for implementing MasterControl, I had to take the time to conduct a major cleanup of our legacy systems. I made the effort to start a national forum so early MasterControl users could share how and where we could refine processes further. I also invested heavily in training users on how to most productively use the new system.
By thoroughly preparing for a new, digital approach and keeping lines of communication continually open to ensure support, I was able to successfully implement the document, training, audit and process modules of MasterControl at an organization as large and complex as the FDA. And the results were immediate: With real-time updates of all documents in review, revision or creation states, we could confidently know who was working on a revision, the status of an approval, or if a document update was overdue. The soft ROI of time saved may have been difficult to quantify, however the benefits were undeniable each time an inspection occurred, or ISO accreditation was at stake.
- “Document Control Poll Results 2018: How Do You Compare With Your Quality Peers?” by MasterControl. March 2018. https://www.mastercontrol.com/gxp-lifeline/poll-suggests-automation-could-solve-85-of-your-document-control-issues/