The effects of the U.S. government shut down and the impact on how FDA is working is all anyone seems to be talking about. Chicken Little is clucking that there is no end in sight! For the small company, delays can be disastrous. However, product development can and should continue! Now is a great time to think strategically to achieve your next development milestone(s).
By Ken VanLuvanee
Recently in our conversations with sponsors, we’ve seen a significant uptick in clients using electronic means beyond just storage on hard drives to manage their documents. That’s a wonderful thing to see and we’re thrilled. In this age of purely electronic assets and required electronic only communication with global health authorities, to see an increasing number of life sciences sponsor organizations recognizing the need to manage their electronic documents and treat them like to assets they truly are is a significant development within the life sciences industry.
We do, however, see a significant amount of confusion about what the various types of electronic systems available are and what they’re best suited to do, as well as what requirements (both practical and legal) each of those types of systems meet.
by Bruce Salkovitz
This is the third in a series of blogs that look at the essential requirements for document management solutions for small teams: SIMPLE, SECURE and COMPLIANT. You can check out our previous blogs in the series:
This blog will focus on COMPLIANCE.