Data Sheet

MasterControl CAPA™
In regulated environments, corrective action and preventive action (CAPA) is
a requirement for addressing and mitigating deviations and nonconformances.
CAPA calls for a systematic investigation of root causes of quality issues and
risks to help prevent their recurrence.

How Can MasterControl Software Solutions Help You?

MasterControl CAPA is designed to automate and effectively manage the CAPA
process and integrate it with other processes, such as document control, change
control, and audit, for a holistic approach to quality management. Here’s how
MasterControl addresses some of the major challenges in implementing CAPA.

Challenges and Solutions

Challenges MasterControl Solution

Inefficient System: Manual CAPA systems are labor- Efficient System: MasterControl automates routing
intensive and inefficient. The routing, review, and and approval of CAPAs and all related documents. It
approval process requires disparate communications provides a centralized repository for all documents,
via email, phone, or in-person meetings. Documents making search and retrieval easy during inspections and
and records are not readily accessible during audits.
inspections and audits.

Disparate Tools: A quality issue stemming from Connected Tools and Processes: MasterControl
an adverse event or a customer complaint or audit connects the CAPA process with other quality
findings typically triggers a CAPA. Under a manual processes. A customer complaint that warrants a
system, different paper forms must be collected CAPA will launch a best-practice CAPA form that
and the data entered into an electronic system. simplifies data gathering. When integrated with
Spreadsheets are used to track data and tasks. training, the system will launch training tasks when
These manual tools are cumbersome and prone to a CAPA that merits a retraining is closed and the
errors. retraining is approved.

1
 Data Sheet

Lacks Visibility: With a manual system, documents Increased Visibility: MasterControl provides a
are stored in different places, making it difficult for dashboard and other tools for a bird’s-eye view of the
stakeholders or auditors to find what they need. entire CAPA process, from launch to close. The status of
Checking the status of tasks and CAPAs requires tasks and any changes will be visible to all stakeholders.
combing through paper or electronic files, email Auditors will find everything they need in one place.
messages, and spreadsheets.

Lack of Oversight: Users with manual tools can’t Increased Oversight: MasterControl provides a robust
track and monitor CAPA cases in real time, which analytics and reporting capability to help managers
could result in delayed resolution of issues. Without monitor quality issues and be proactive. The Events
an effective reporting system, managers are unable Analyzer tool lets users track recurring issues and
to spot trends and systemic quality issues. They don’t perform effectiveness checks on CAPAs in real time.
have the capability to see all quality events in one
report.

Features and Benefits:

Automated CAPA Process: MasterControl automates all CAPA-related tasks for

a more effective and efficient CAPA management. This includes routing, follow-
up, and approval.

Event Analyzer Agent: MasterControl provides a robust monitoring tool for

detecting trends. This add-on tool will send out real-time alerts when certain
thresholds defined by the user are met. It creates a permanent record of tracking
and trending activities.

EventCard Reports: This add-on allows users to see all quality events at once.
No need for a complicated search of separate deviations, customer complaints,
or other reports for tracking and trending purposes. EventCard will give you a
quick access to quality and risk information, which is crucial during audits and
inspections.

Process-to-Process Launching: A CAPA form can be launched from another

process or form. It can be launched from the audit process for a seamless
response to observations. Relevant data from a form will be automatically entered
into the CAPA form, reducing errors from manually transferring data.

Automated Revision Control: This feature ensures that users will not make the
mistake of using obsolete or unapproved documents. When a new revision of a
document becomes effective, access to the prior version will be stopped.

Responsive Interface and User-Friendly Navigation: MasterControl’s Hub is a

sleek interface consisting of a collection of tiles that are easy to view, use, and
navigate. The tiles function as menu items that let users access their tasks quickly

MasterControl CAPA™ 2
 Data Sheet

and navigate to another page and perform other actions. The responsive user
interface will adjust to any screen, whether it’s a desktop computer or mobile
device or tablet.

Powerful JReport-driven Analytics Tool: This highly customizable tool allows

users to view, filter, and interact more with their data. It provides robust charting
capabilities and viewer and editor modes. The latter allows users to change
column size, add or remove columns, create new data columns, and more.

About MasterControl

MasterControl Inc. creates software solutions that enable life science and other
regulated companies to deliver life-improving products to more people sooner.
MasterControl’s integrated solutions accelerate ROI and increase efficiencies by
automating and securely managing critical business processes throughout the
entire product lifecycle. More than 1,000 companies worldwide, ranging in size
from five employees to tens of thousands, rely on MasterControl cloud solutions
to automate processes for new product development, clinical, regulatory, quality
management, supplier management, manufacturing and postmarket surveillance.
MasterControl solutions are well-known for being scalable, easy to implement,
easy to validate and easy to use. For more information, visit
www.mastercontrol.com.

© 2019 MasterControl Inc. All rights reserved.

DSDVXX0USENLT-01/19

MasterControl CAPA™ 3