There is a lot of talk these days about document management systems. There are dozens of products on the market – some targeted for general information
storage and others specifically aimed at the pharmaceutical industry. Some products are very simple, have limited features (e.g., file sharing), and are relatively
inexpensive whereas other products are complicated, feature a multitude of “bells and whistles” (e.g., complex security models, built-in annotations, system-generated notifications, electronic signatures, work flows), and are very expensive to implement.

How is a small biotech company to know whether a system is needed, which features are important, and how much investment is appropriate?

Document management is not always easy. For small biopharmaceutical teams, lack of document controls can open the company to unintended risks. Choosing a document management solution should streamline processes while protecting valuable content. If it doesn’t, it isn’t the right tool. Facet Life Sciences is redefining document management for small teams. Our practice-based approach is driven by experience, expertise and a steadfast commitment to supporting small, innovative teams with right-sized technology solutions.

Gemstone is both new and a new type of electronic document management system (EDMS). Built entirely in the cloud, Gemstone is a SaaS-based (software as a service) solution with no installation required. The solution is truly a service and, as such, can meet 21 CFR Part 11’s requirements. However, the traditional assumptions associated with validating “on-premises, installed software” do not all apply.