Spreadsheets are Error Prone and Pose Problems for Companies in the Life Sciences Industry Today
For companies in the regulated Life Sciences field, Excel-based Document Control and Training Systems that contain spreadsheets are more error prone and have significant drawbacks. The potential for error is always greater when companies use a spreadsheet because there is difficulty in verifying not only the spreadsheet itself, but also the data it produces. A spreadsheet's basic purpose is to analyze and visualize data. But when it comes to preventing users from seeing this sensitive information, permission-based access and privileges are not some of its top priorities.
Having many GxP compliance-related activities means you have critical information that needs validation to ensure accurate and secure delivery. With developer and operator errors associated with spreadsheets for so many years, experts sometimes question its integrity and companies now need software solutions with features that allow them to have greater document collaboration and control. When data in these spreadsheets is incorrectly calculated and reported, both due to accidental, and intentional operator actions, this causes these regulated companies to violate compliance rules or potentially damage their reputations.
Poorly structured spreadsheets are also more prone to errors, can increase audit costs and cause these other issues:
Additional Applications are Needed
If you use spreadsheets for employee training purposes, you’ll still need other applications to organize information for better efficiency and effectiveness. Having updated training management practices is so important in this field because it impacts compliance, quality, health and safety. Trying to send out instructions, view courses on a calendar, track attendance, record scores and provide reminders on a spreadsheet is next to impossible without some additional process to help all these requirements get organized in a more convenient way.
Not Designed for Better Workflow
Spreadsheets are great for storing information, but can't handle lots of processes or workflows at the same time. If you try, you'll get an "Excel cannot complete this task with available resources error". 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. You start out with one or two small spreadsheets, and then before you know it, there are dozens and sometimes hundreds more. What if you need to access information on the go? Or, what if you and a colleague both update information at the same time? This can cause added stress and additional work.
Greater Potential for Security Breeches
Trying to get an Excel or other Microsoft driven system to distinguish between permissions, validations and accept electronic signatures is nearly impossible to do. This adds compliance risks to the whole process because we now have greater accountability. This is due to the Sarbanes-Oxley Act which enforces governance, risk and control and states that there are legal consequences for these error prone spreadsheets. Plus, now there is an even greater need for more vigilance because a quick search of the Internet shows that some sites are even offering “cracking” 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.
There have also been numerous articles warning of the dangers of these spreadsheet errors. A cut-and-paste error in a spreadsheet cost TransAlta, a Canadian power generation company, $24 million in overpayments. A $2.6 billion error occurred when another company left out a negative sign turning a $1.3 billion loss into a $1.3 billion gain. 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.
The good news is that technology now enables companies to take advantage of electronic Quality Management Systems to perform tasks without relying on spreadsheets and greatly reduces the potential for mistakes. Do you handle sensitive data? What would happen if you lost critical information on a spreadsheet and what would the cost be to your company? The true cost goes far beyond the initial purchase price of an Excel-based system. This is because companies reuse spreadsheets from year to year and 90% of them have errors (Cooper's & Lybrand study). These errors can jeopardize an entire organization's reputation and hidden errors and inaccuracies can also lead to very bad decision-making.
To get a deeper look at what Paper and Excel based Quality Systems really cost, try our free calcualtor below