- THE MAGAZINE
- WEB EXCLUSIVES
Sanmina-SCI was seeking an automated 21 CFR Part 11 solution for managing its training records within its medical division, thereby meeting regulatory requirements and eliminating the risks of noncompliance. With an FDA 21 CFR Part 11-compliant system, the plant is able to track its employees’ training and certification, including identification of training requirements, and ensure that the employee is current and certified. Pilgrim’s SmartTrain provides those capabilities and meets Sanmina-SCI’s desire for a corporate-supported solution that is scalable.
“With SmartTrain, Sanmina-SCI looks to improve productivity by eliminating the effort required to maintain parallel data and workarounds to obtain data in the required formats,” says Tim McGinnis, vice president of quality and regulatory affairs, Sanmina-SCI Medical Division. “We expect to significantly reduce the effort required to maintain training records and qualifications, and improve the accuracy of ‘self-certification,’ thereby enabling more efficient and rapid audit approval.”