The value of an early stage life science company is tied to its documentation. Transitioning from an informal environment where documents exist on local desktops, email exchanges and in extreme cases of old world technology, filing cabinets, to a structured, digital document system is a key step in securing a company’s intellectual property. Risk of losing files or the most recent versions of files, due to simple human error, increases in orders of magnitude as your stack of documents and team grows over time.
Examples of simple, unintended human error in document management take all forms
- Overwriting a document or part of its contents
- Having more than one copy of a document and not being able to establish the “true” valid version
- Computer crash renders a document inaccessible
- Losing a document due to misfiling
- Spilling coffee on the computer
- Virus attacks hardware
- Document exits building in possession of an employee
The realization of any poor outcome costs time and money in the life cycle of a product. A secure, regulatory compliant document management system significantly mitigates the negative impact of these unintentional, human mistakes. A DMS simplifies the task of identifying the “true” version of any document by placing controls on duplicate file names and versioning. A sophisticated DMS system maintains version control by preventing partial or complete overwriting. Version control also gives a team of professionals the ability to retrieve historical versions of a document.
Filing and locating documents is also greatly simplified when using a document management system with a set CTD structure for authoring that conforms to ICH specifications for Headings & Hierarchy.
Finally, security is an issue on all levels, regardless of scale or scope. Breaches occur at a file share level of sophistication – email round robin, storage on individual desktops, USB file swaps and unsecured commercial cloud storage options. These unstructured environments expose a life science company whose value is directly tied to its growing stack of documents to several points of vulnerability and failure.
A formal DMS built on a highly-rated infrastructure platform, and here we’re talking about cloud-based solutions, and equipped to restrict access to documents based on user permissions, is a much better safeguard against theft of proprietary data than a loose assortment of workarounds like email and USB drives.