MasterControl CAPA

What MasterControl CAPA is

MasterControl CAPA is web-based software for managing corrective and preventive actions in life sciences and other regulated organisations. It helps teams investigate quality issues, identify root causes, and work to prevent recurrence. CAPA forms can be started from complaints, deviations, nonconformances, audits, and out-of-specification events. Root-cause analysis methods include 5 Whys, Fishbone, 8D, FMEA, Fault Tree Analysis, and other approaches. The system automates routing, notifications, escalations, and approvals, and supports effectiveness checks, electronic signatures, and audit trails. Connected quality processes can initiate change control, training verification, and task tracking. Analytics provide visibility for examining data and identifying trends. MasterControl describes the solution as supporting FDA and ISO quality requirements; its controls include time-stamped audit trails and electronic signatures designed for FDA 21 CFR Part 11. It is available on the web. Pricing is provided on request and depends on organisational needs, licensing, and package.