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The solution offers flexibility in terms of design, routing, and user and security roles to adjust to the way you work. It
provides advanced tracking functionality, incorporates escalation, and offers best-practice features that prompt users
with selected data to reduce data entry and avoid mistakes common in manual data entry. Captured data is stored in an
ODBC-compliant database, enabling reporting and in-depth analysis through our powerful built-in Analytics tools.
Here’s how MasterControl Supplier Deviation addresses some of the major challenges companies face in establishing and
maintaining forms-based processes.
Arrival of Nonconforming Material at your Loading Communication of Issues before Material is Shipped:
Dock: Without a formalized supplier deviation program, MasterControl Supplier Deviation allows a supplier to
suppliers may ship rather than investigate in case of request an exception to specification before material
“minor” non-conformances. Processing at the loading dock is shipped. This eases the pressure on your quality
and returning unacceptable material after undergoing the department to accept the material and increases efficiency.
incoming QC process creates unnecessary costs and
delays.
Inefficient Paper Forms System: A paper-based forms Cost-effective Automated System: MasterControl
process can be plagued with inefficiency and such issues automates forms-based processes such as Supplier
as: filling out the wrong form, not completing the right form, Deviation and offers best-practice features that
and sending the form to the wrong person. prompt users with selected data. It automates routing,
notification, escalation, and approval for faster turnaround.
MasterControl is Web-based, so employees, customers,
and suppliers can participate in forms-based processes
(i.e., data input and verification) from virtually anywhere.
Poor Data Capture: Forms are designed to gather Accurate Data Capture: In creating new forms or
accurate and complete information critical in compliance. improving existing ones, companies can use a variety of
With paper forms, the onus lies with the operator to input field formats for accurate and accelerated data collection.
accurate and complete information, and then for an analyst With a click of a mouse, a user can select common
to accurately transfer this information to a spreadsheet or responses keyed in the form fields that allow a list of data
other analysis tool. options previously entered. This helps ensure data is
entered correctly into the form. Fields can also be set up to
calculate data using simple or complex math operations.
Disconnected Processes: Manual systems don’t connect Connected Processes: MasterControl integrates different
forms-based processes (audit findings, corrective action, quality processes for more effective and efficient quality
etc.), making continuous improvement almost impossible. management. For example, a CAPA form can be launched
For example, if the customer complaint process is not directly from an OOS form, connecting one process to the
linked to the corrective action process, a critical complaint next. Relevant information will be automatically entered
may languish indefinitely before it can be acted upon and into the new form, reducing data entry and avoiding
remediation is initiated. mistakes common in manual transfer of information.
• Best Practice Form: A pre-configured, multi-page form prompts MasterControl users to collect and track all relevant
data and guides them through the process while allowing responsible personnel to make appropriate decisions with
the information. The form is automatically distributed to designated personnel on a pre-determined route and can
escalate if not processed in a timely manner.
• Best-Practice Process: The MasterControl Supplier Deviation module incorporates a three-step process that guides
users through the process, beginning with the Supplier Deviation Request through Supplier Deviation Disposition and
QA Disposition.
• Analytics Reporting Tool: MasterControl includes a built-in tool that comes with a standard set of pre-configured
reports that can be adjusted and customized by the end user. Supplier Deviations can be analyzed by product,
specification, category, disposition, etc. These data-mining capabilities can give important insight into systemic quality
issues and serve as an input to supplier evaluations.
• Audit Trail and Electronic Signatures: MasterControl provides reporting, electronic signature, and time-stamped
audit trail capabilities that fully satisfy the FDA’s 21 CFR Part 11 regulatory requirements.
• Change Control Integration: When integrated with MasterControl Change Control™, MasterControl users are
enabled to seamlessly initiate the change control process to update specification or other internal documents as
required.
About MasterControl
MasterControl Inc. is a global provider of GxP process, quality audit, and document management software solutions for
life science companies. MasterControl™ products are easy to use, easy to deploy, easy to validate, and easy to maintain.
They incorporate industry best practices for automating and connecting every stage of the product development cycle,
while facilitating regulatory compliance. By combining an integrated platform with a continuum of risk-based software
validation products and services, MasterControl drives down the total cost of ownership and enables customers to extend
their investment across the enterprise. Hundreds of companies, including 50 percent of the top 20 pharmaceutical
enterprises, currently use MasterControl solutions for easier compliance, faster validation, and better process
management. For more information about MasterControl, visit www.mastercontrol.com, call: 800-825-9117 (U.S.);
+44 1256 325 949 (Europe); or 03-6801-6147 (Japan).