Leiner handles healthy growthwith Pilgrim Software compliance suite

For a while, Leiner Health Products was just a small company serving a limited number of large accounts. Then the Carson, Calif.-based company grew to become the largest domestic private-label manufacturer of vitamins, minerals, and nutritional supplements; and the second-largest U.S. manufacturer of private-label, over-the-counter pharmaceuticals.

The problem—as sometimes happens when a company experiences rapid growth—was a mixture of disparate processes, some of which were outmoded, too complex, or simply unnecessary. Faced with a mandate to grow the company but not the head count, Leiner's management team started evaluating its operations.

What they found, says Tim Fischer, director of regulatory compliance, were many disconnected paper-based systems, global variations among operational practices, insufficient visibility, delayed deviation recognition; and laborious records management. The consequences were deviation recurrences, delayed complaint handling, drawn-out audit preparation, and inconclusive evaluation/assessment of suppliers and vendors.

Leiner started looking for an integrated compliance solution that could be implemented across the board to address these inefficiencies while managing Leiner's vast regulatory requirements. It found those capabilities in Pilgrim Software's SmartSolve suite, which oversees document and complaint handling, and corrective-action and audit management.

Fischer says since implementing the suite, Leiner is better expediting customer inquiries and experiencing greater control at an organizational level.

“When we went live with the SmartSolve suite, we quickly recognized the resulting enhanced internal efficiencies and the positive impact on our overall business process,” concurs Ron Lapre, VP of regulatory compliance for Leiner.

Lapre says Leiner now plans to add user licenses to enable broader employee access to SmartSolve to strengthen corrective-action procedures; enhance the complaints process, as well as document control and availability; and streamline auditing processes.