FDA RECOMMENDS DATA INTEGRITY CONSULTANTS
When do you need to hire a data integrity consultant, and what should you expect from them? The FDA advised at least 4 firms via warning letters in 2014, telling them specifically what their data integrity consultants should do. In two of these cases, the firms had already hired consultants. In the other two, the FDA actually recommended that the companies seek a consultant.
These four warning letters were triggered by egregious data integrity violations at firms overseas, but they provide an interesting insight into the FDA’s views of consultants and data integrity audits.
First, these letters provide evidence that the FDA expects companies to ensure that they have the appropriate staff to carry out data integrity audits, and that they should outsource this activity if they don’t have the in-house expertise to do this. Second, these letters clearly define the focal points for data integrity audits. The ultimate goal of activities described in the warning letters seems to be determining the extent of the data adulteration observed by the agency, but it can still provide a useful guide for those who are actively seeking to achieve compliance. These warning letters emphasize the need to ensure consistency, accountability, traceability and timely recording for critical data.
What does all this mean for companies who take greater care with their data? It shows that regulated companies should be sure that they apply the right expertise to ensure data integrity. When considering cloud hosting, regulated companies should take a close look at how their provider could safeguard their data – or endanger it. Truly compliant cloud hosting is designed to satisfy GxP requirements, and is backed by an experienced compliance staff to help ensure that systems are secured and managed to ensure data integrity.
Think of your data integrity requirements when auditing your potential IT partner. At ByteGrid, we can help you achieve end-to-end data integrity, and full compliance for your system, documented to agency standards. You’ll find that a cloud hosting provider with compliance experience offer a measure of security that you won’t find with other data centers.