Data Sheet
MasterControl CAPATM
Quality Excellence
Transform quality management
with the most complete,
connected, and intelligent QMS
available today. Choose the
proven platform that empowers
you to digitize and automate the
management of quality events,
documents and training across
your entire product life cycle —
and get your products to market
sooner.
Qx
Quality
MasterControl CAPATM automates all corrective
and preventive processes. It integrates with other
quality processes, such as document control,
change control, audit and customer complaints,
for a holistic approach to quality management.
The result is comprehensive, streamlined CAPA
management to ensure higher quality, safer
products and compliance with 21 CFR Part 11.
Key Benefits
1 Efficiency
Automates routing and approval of CAPAs and all other related
documents, which eliminates bottlenecks and production delays. It
provides a centralized repository for all documents, making search and
retrieval quick and easy during audits.
2 Unified Processes
If an event merits updated documentation and associated training,
these tasks are automatically launched to ensure employees are
functioning with accurate, up-to-date procedures.
3 Visibility
Monitor the entire quality event management life cycle from input,
correction to effectiveness checks.
 Data Sheet

A Closer Look at Features

1 Closed-Loop CAPA
Efficiently oversee all CAPA-related processes, avoid errors and
omissions and maintain a complete, compliant and traceable audit trail.

2 Event Analyzer
A robust tool that helps detect trends. It sends out alerts when
predetermined thresholds are reached or a trend is spotted that may not
otherwise be identified. It tracks all quality and trending activities and
creates a permanent record of this information.

3 Process-to-Process Launching
A CAPA form can be launched from other processes or forms, which
preserves data integrity. Relevant data from a form will automatically
be entered into the CAPA form, reducing errors from manually
transferring data.

4 Advanced Analytics and Reporting

Dynamically capture, trend and link data needed to solve problems and
improve quality processes. Create a variety of customizable reports,
i.e., issue summary, aging/overdue, cycle time, etc., for more efficient
management of quality and compliance.

5 EventCard Reports
Quickly access quality and risk information, which is valuable during
audits and inspections.

About MasterControl
MasterControl Inc. is a leading provider of cloud-based quality, compliance and
production management software for life sciences and other regulated industries.
Our mission is the same as that of our customers – to bring life-changing products to more
people sooner. The MasterControl Platform helps organizations digitize, automate
and connect critical processes across the regulated product development life cycle.
Learn more at mastercontrol.com

Dx Cx Rx Qx Sx Mx Px
Development Clinical Regulatory Quality Supplier Manufacturing Postmarket

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