Spreadsheets are error-prone and pose problems for modern Life Sciences companies
Companies in the regulated Life Sciences space that rely on Excel- or other spreadsheet-based Document Control and Training Systems are at a considerable disadvantage because those systems weren't designed to handle such robust tasks. In fact, various studies over the past few years report that almost 90% of spreadsheets have "significant" errors. And a majority of reported errors were caused by human error, meaning they could have been completely avoided.
A spreadsheet's basic purpose is to visualize and analyze data. However, adding GxP-related activities like validated electronic signatures and permission to view sensitive information adds another level of complexity that spreadsheets can't perform as well as a dedicated electronic Quality Management System (eQMS).
Poorly structured spreadsheets are also more error-prone, can increase the duration and cost of audits, and cause other issues:
The need for additional applications
If you use spreadsheets for employee training purposes, you’ll still need other applications to organize information for better efficiency and effectiveness. Having an updated training management process is critical because it impacts compliance, quality, health, and safety. Trying to send out instructions, view courses on a calendar, track attendance, record scores, and provide training reminders on a spreadsheet is next to impossible without additional applications.
Poor workflows and data thresholds
Spreadsheets are great for storing information, up to a point. Once you start running lots of processes or workflows at the same time, you'll hit a threshold and receive an "Excel cannot complete this task with available resources error" message. When this happens, Microsoft advises choosing less data or closing other applications. Serious problems can also occur as an Excel file grows and more people get involved. Before you know it, what began with one or two small spreadsheets can turn into dozens or hundreds more. What if you need to access information on the go? What if you and a colleague both update information at the same time? The potential for added stress and work just got higher.
Threats of security breaches
Trying to get an Excel or other Microsoft-driven system to distinguish between permissions and validations, and to accept electronic signatures is difficult. This adds another level of compliance risk that requires greater accountability. This is due to the Sarbanes-Oxley Act , which enforces governance, risk, and control, and states that there are legal consequences for error-prone spreadsheets.
A newer threat that requires even more vigilance is the appearance of some websites that offer to “crack” spreadsheet passwords or other hidden items, with malicious intent. Trying to secure spreadsheets by locking cells and hiding worksheets is no longer practical and just isn't safe anymore.
Spreadsheet errors can have expensive consequences. A cut-and-paste error cost TransAlta, a Canadian power generation company, $24 million in overpayments. Another spreadsheet error cost J.P. Morgan $6.2 billion. And Barclays, a British multinational banking and financial services company, was legally bound to buy millions of dollars of assets from a bankrupt company because of an error that occurred when someone converted a spreadsheet to a PDF file.
These are just a few examples of financial errors. In Life Science, private patient data and human life is always at risk. The good news is that regulated companies of any size, at any phase, can take advantage of eQMS solutions to handle demand without relying on spreadsheets and the potential mistakes they cause.
Do you handle sensitive data? What would happen if you lost critical information on a spreadsheet? What would the cost be to your company? To its reputation? The true cost goes far beyond the initial purchase price of an Excel-based system. If you're looking to keep costly errors in check and improve efficiency, read on to discover if it's time to invest in an eQMS.