Sometimes you have to think inside and outside the box.
Software validation shores up the technology that stores a pharmaceutical company’s vital data inside
WHEN’S THE LAST TIME
A FRIDGE SAVED
ANYONE’S LIFE?
The Situation
Years of testing and millions of dollars go into developing a new drug. It’s precision work, highly nuanced and sophisticated. By contrast, the blocky, clunky refrigerators that store many drugs might not seem quite so important. But if that unassuming fridge is on the fritz, if the door doesn’t seal tightly, if it goes just one degree above the strict temperature range required, all the precious cargo inside may spoil.
In the life sciences industry, Enterprise Resource Planning (ERP) systems function a bit like those fridges, storing data about procurement, manufacturing, and distribution that is nearly as crucial as the chemical compounds in life-saving drugs. A global pharmaceutical company implementing a new SAP ERP recognized this fact and looked to Good Practice (GxP) guidelines for software validation to make sure its technology was fit to preserve the integrity of what was within.
The company knew that errors in the software could have serious consequences. The Food and Drug Administration’s Code of Federal Regulations (FDA 21 CFR Part 11) requires security, accuracy, and reliability in software affecting patient safety and product quality. If software systems aren’t properly validated, the FDA and similar regulatory bodies in other countries can levy heavy penalties and issue consent decrees to shut down specific plants or product lines. Even more importantly, patients’ lives can depend on receiving the company’s drugs, and receiving these drugs depends on an entire constellation of data points converging correctly within the ERP.
THE SOLVE
CHECKING SYSTEMS
THAT STORE
CRUCIAL DATA IS
MORE THAN JUST
CHECKING A BOX.
The Impact
With the first phases of its new ERP system implemented and validated, the pharmaceutical company has seen positive effects—in terms of both what the company can avoid and what it stands to gain.
Regulatory compliance:
Through software validation, the company is positioned to maintain compliance with the requirements of the FDA and similar regulatory bodies in the other countries where it operates and is better able to minimize potential fines, penalties, and legal liabilities.
Improved efficiency and cost savings:
Validating the ERP helps identify potential issues that may impact system performance right at the outset, reducing the risk of system downtime or data loss. Finding those potential issues early on can decrease the cost of remediation and rework.
Patient trust and safety:
Most importantly, the company is more confident in its software’s ability to bring life-changing treatments to the people who need them. Thoughts of the ERP system won’t ever cross patients’ minds, but it’s humming away, preserving the data inside and making the company’s mission possible.