Case Study: Aplicare achieves efficient, FDA-compliant electronic document management with MasterControl

Adoption of MasterControl Key to Efficient, FDA-compliant Document Management at Aplicare

Aplicare, a Branford, Connecticut manufacturer of antimicrobial products, faced mounting regulatory pressure to document and control quality records in line with FDA requirements and 21 CFR Part 11. Its hybrid system — electronic drafting followed by manual printing, routing and signatures — was slow and error-prone, often taking one to two weeks for approvals, so the company committed to a centralized electronic document management system by November 2001.

Aplicare implemented MasterControl using prebuilt validation (IQ/OQ) tools, templates and training, completing data import, validation and rollout in about six weeks. The system provided automated revision control, audit trails, flexible routing/notifications and Part 11 security features, delivering faster approvals, consistent compliance (no observations in an FDA inspection) and ongoing vendor support.

Aplicare

Buccetti