Death by Spreadsheet: The Gremlins Paradox
Craig Gassman is Associate Director of Regulatory Operations, Karyopharm
I’ve recently begun a campaign to eliminate all Excel tracking spreadsheets within regulatory here at Karyopharm, a clinical-stage pharma in Boston, Massachusetts. I’ve worked at organizations big and small, and everywhere I’ve been, manual Excel trackers are still the predominant tool used to track submission components. The hours spent maintaining and reconciling is ludicrous. It’s out of hand and I’d had enough. If you’re reading this, likely so have you.
There are a number of issues when tracking submissions manually – ranging from entry errors, the lack of connection to content, and potential file corruption. However, the biggest challenge is version control, since trackers are frequently updated and reflect the activities of multiple people. If one person controls the tracker, it can quickly become out of date. If multiple people are contributing, you’re at risk of a version control nightmare, which I refer to as the Gremlins Paradox. In the movie Gremlins, whenever water spills on an adorable, furry creature called a Mogwai, it multiplies. Feed a Mogwai after midnight and pandemonium breaks loose. Similarly, emailing just one version of a submission tracker has the potential to open the floodgates and spawn evil clones…here come the Gremlins! It becomes nearly impossible to identify which gremlin (spreadsheet) begat the next. The same issues apply to trackers that exist in fileshares, SharePoint or other controlled means. Submission tracking is innately dynamic, so why do we use tools that make it become static?
I have now started using the auto-tracking and reporting mechanisms in Veeva Vault Submissions to counter the chaos that spreadsheets produced. Since Vault manages both content and data, the pertinent tracking information for submission components is maintained within Vault, connected to the respective documents. Using document lifecycle states and some additional configured metadata we can track documents’ progress from inception to publishing (and everything in-between). Planning and tracking directly within the system eliminates the recordkeeping we used to do manually and provides the real-time, accurate updates that are so hard to achieve with Excel. In doing so, we have eliminated the version control Gremlins that plagued other submissions.
The mantra that I repeat to colleagues, and myself, is “Automatic tracking, live reporting, connected content.” It’s a paradigm shift that some are hesitant to accept, but once they’ve seen tracking as an organic part of the process, they quickly get onboard. Instead of asking, “Can I see the tracker?” each submission stakeholder already holds the key (which is really a URL) to the self-service tracking report. It would now be hard for my colleagues to ever return to the archaic trackers of old.
Submission components and their trackers should no longer live in isolation. By combining them, regulatory operations provides the organization with a higher level of information management, enabling the company to execute with greater precision. Knowledge is power, but only if it’s accurate.
Bringing real-time tracking to the organization is just one aspect of the changing role of regulatory operations. Change in the regulatory world is inevitable. But being ready for change is a choice.
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