Improving quality and maintaining compliance depends upon robust CAPA management. The purpose of CAPA is twofold: to determine why quality events such as nonconformances and deviations have occurred, and to prevent them from happening again. By nature, CAPA processes span various quality systems and the data they produce. A digital and integrated CAPA solution allows companies to connect key quality channels and downstream processes throughout the entire product life cycle. The result is streamlined and thorough CAPA management for better product quality, safety and overall compliance.
MasterControl CAPA software digitizes and automates CAPA processes such as routing, notification, escalation and approvals to avoid bottlenecks and expedite issue resolution.
When CAPA is integrated with core quality management systems, automatic initiation of change control, training verification and task tracking ensure compliance with FDA 21 CFR Part 11 requirements.
A fully digitized and automated CAPA system provides the ability to launch forms directly from customer complaints, deviations, nonconformances, audits, out of specifications and more.
With visibility into the entire CAPA process, you can analyze data and identify trends to help improve overall quality management.
MasterControl and its partner, i4DM, have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009. The two companies recently expanded their FDA project, serving as the QMS providers for a second FDA division, the Division of Pharmaceutical Analysis, which is part of the Center for Drug Evaluation and Research (CDER).
Corrective and preventive action is the single most critical element of any quality system, and must be managed as such to satisfy both FDA and ISO requirements. See how MasterControl CAPA software offers an easy-to-use, closed-loop solution for automating the CAPA process and integrating it with other quality processes for a holistic, connected and compliant approach to quality management.
MasterControl software integrates CAPA processes with the entire product life cycle for a holistic approach to quality and CAPA management.Get the Free Data Sheet | MasterControl CAPA™