Records secured at Specials Clinical

Because the company performs clinical trials and drug labelling (along with a range of production development and packing services for clinical trials), security, validation and regulatory compliance are key. Hence its need for a system up to the FDA's 21 CFR Part 11 for electronic records – an increasingly common requirement across several sectors beyond pharmaceuticals, including food, but also others. Elaine Mackie, packaging manager, says it wasn't an easy problem to solve: "Initially, there was no system for printing labels, especially labels for randomised studies and projects." However, Prisym Medical software uses encryption and links activities to individual users, while providing time and date stamping. So it's totally secure for label design and approvals, as well as for automatically gathering data and label printing. Since it also integrates with several ERP and MRP systems, this looks like a good one to check out.