Few industries face record-keeping hurdles of the complexity and stringency faced by the pharmaceutical industry.
The business need to confirm and document the safety and efficacy of a new product, the potential threats of litigation if problems arise after a product is launched, and the documentary requirements of the regulatory agencies add up to a perfect storm of record-keeping demands throughout the lifecycle of a product. This documentary lifecycle extends from the earliest stages of research and development to many decades after the product is no longer marketed.
The weight of this task can be measured in the sheer volume of documentation required in regulatory submissions for new product approvals. Documentation for a single research study can be tens of thousands of pages with a full submission including multiple study results.
Though cutting-edge research is conducted using the latest technology, often the key results are compiled and maintained on unconnected Microsoft Word documents and even handwritten notes.
Extend this complexity over multiple regulatory jurisdictions, different languages, patent laws, joint ventures, subcontracted and outsourced research, and it is no surprise that paper submissions were often delivered by the truckload!
I invite you to read our white paper profiling more about the background and solutions that face this challenging industry “Optimizing Regulatory Submission Processing” [PDF].