Document management is an essential function for pharmaceutical companies. It allows them to efficiently store, organize, and retrieve important documents related to drug development, clinical trials, manufacturing, distribution, and other business critical information. Failure to effectively manage these documents can result in serious consequences such as fines, delays in product launch, and even legal action. While the need for a document management system is understood by most mid-market pharma companies, many still do not have one.
Addressing Regulations with Document Management
My first exposure to the pharma space was well over twenty years ago, and even back then, meeting regulatory requirements was a paramount concern. That was only a few years after 21 CFR Part 11 became effective in the USA (August 1997), and within a few years, other regulatory authorities in other countries followed suit. In response, software vendors were already building whole new businesses based on delivering systems that would allow their customers to address the new regulations.
Back then, the specific focus of those systems was on document management, which made sense because that was the primary thrust of the regulation. It said we needed to ensure that the documents we use in researching, developing, and marketing pharmaceutical products and medical devices had to be managed meticulously, with complete documentation of the lifecycle of each document from draft right through review, approval, and revision.
The market responded with products like Documentum, FileNet, and OpenText. Each platform provided core document management capabilities like version control, check-in and check-out, and audit trails to address the provisions of the new regulations.
Today, hundreds – perhaps thousands – of software and SaaS solutions are available to help you address the extensive regulatory requirements in the pharma industry. We have clinops solutions for managing trial master file documents, electronic lab notebooks for documenting research activities, quality management systems to ensure good clinical practice, and regulatory management solutions to manage interactions with regulatory authorities.
These department- and function-specific applications are great tools for managing the detailed processes that characterize every aspect of a pharmaceutical company’s business. But they tend to act as independent silos of automation, not integrated and mostly unaware of each other. And underneath all of them remains a critical need to manage documents in a manner compliant with regulatory requirements.
The Need to Manage All Business Documents
I am NOT arguing for a return to the approach we took twenty years ago, which was to build custom applications on top of the aforementioned document management platforms; We have evolved past that. The availability of pre-build applications that are lower cost, easier to use, and far easier to deploy means that more companies benefit, and we can discover and bring to market more products that improve human lives.
What I AM saying, however, is that we need to maintain a focus on the documents that underlie our business processes. Because no matter where they come from, how they are created, and what process they enable, we need to track them. And having an effective document management system in place for all documents from across the organization remains a foundation for ensuring compliance.
Some examples illustrate my point. While you may have specific applications for managing clinops and manufacturing processes, I am certain you still have many documents outside those systems. They might be SOPs, vendor documents, letters between your company and the regulatory authority, or any other typical forms or documents that every pharmaceutical or device company uses. Where do these documents live? If the answer is “on a shared drive” or “in Dropbox,” it is a certainty that those documents are not being managed in compliance with regulatory requirements.
Following this thinking to its logical conclusion means that every life sciences company needs more than process-specific applications. They STILL need an underlying document management system. Because inevitably, not every document produced or received by your company lives inside one of those applications.
A modern document management system (DMS) looks very different from what we had twenty years ago. They still address all the basic document management functions such as version control, access control, e-signatures, and audit trails, but they do so at a very modest cost and, as cloud-based systems, with basically no IT resources required.
More importantly, modern DMS applications like Scigeniq DMS are intuitive and user-friendly, so onboarding users requires little training.
Document Management is Foundational
Twenty years or so later, every pharmaceutical or device company still needs a DMS…it is the foundation of ensuring compliance with regulatory requirements. But the good news is modern document management systems make the process of implementing document management much easier, much less costly, and far more effective than was the case back then.
Interested in learning about Scieniq’s document management solution? Request your demo today.