EDC – The Comprehensive Compliance Solution?

In today’s highly regulated world, compliance is one of the most pressing issues that life science companies must address. Companies are constantly looking for more efficient ways to account for and manage the increasingly wide range of regulations being imposed. Compliance officers must look toward technological solutions that focus on electronic data capture (EDC) and data management that can help them meet regulations at the installation point, and provide flexibility to make changes as and when required in order to meet future regulations.

As too many companies have discovered to their cost, failing to comply with regulations can lead to damaging and costly situations that impact brand reputation and bottom lines. Several recent high-profile incidents have highlighted this fact and have driven a renewed focus on compliance, putting companies under the microscope with a more stringent approach to regulations.

While life science companies are no strangers to compliance, changes have meant that companies must comply with 21 CFR part 11, the US Health Insurance Portability and Accountability Act (HIPPA), GxPs, Sarbanes-Oxley and regulations imposed by the FDA, EMEA, DEA, EPA and other agencies.

So how do these regulations actually affect life science companies? Let’s take, as an example, good manufacturing practices (GMPs), which the FDA introduced to ensure that life science products were produced in a manner that was supported by industry best practices. At a high level these guidelines, which have been refined over time as technology and practices improved, ensure that equipment and facilities are properly designed, maintained and cleaned, standard operating procedures (SOPs) are well documented, a quality unit exists, and personnel and management undergo extensive training. In addition to these guidelines, other specific regulations are found in CFR 21, which is divided into parts, dependent on the life science sector.