MasterControl Supplier Deviation™

MasterControl Supplier Deviation™

The supply chain for FDA-regulated companies poses many challenges. Suppliers are considered an extension of the
company and thus must be shown to be FDA-compliant themselves. They have to be evaluated, audited and monitored.
Their shipments have to be tested for compliance with a material’s specifications. Under very specific circumstances,
exceptions from the written specifications can be made after appropriate review by the quality and engineering
departments. However, waiting for this assessment until after the shipment has arrived at your loading dock puts undue
pressure on your quality department and creates unnecessary costs in the event that a delivery is declined.

How can MasterControl help you?

Many of MasterControl’s regulated customers rely on our integrated suite to automate the process of collecting and
controlling data critical to compliance. MasterControl Supplier Deviation creates a formal process where suppliers can
request an exception to written specifications. Materials are shipped only after the appropriate individuals have reviewed
and approved the request and provided proper justification.

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.

Challenges MasterControl Solution

Unavailability of Objective Data on Supplier
Performance: In environments without a formalized or
with a paper-based supplier deviation process, objective
data on a supplier’s performance can be hard to come by.
Collection and Analysis of Supplier Deviation Data:
MasterControl Supplier Deviation stores all data on every
requested supplier deviation. This data can be analyzed in
detail and serve as an input to your supplier management
program.

Arrival of Nonconforming Material at your Loading
Dock: Without a formalized supplier deviation program,
suppliers may ship rather than investigate in case of
“minor” non-conformances. Processing at the loading dock
and returning unacceptable material after undergoing the
incoming QC process creates unnecessary costs and
delays.
Communication of Issues before Material is Shipped:
MasterControl Supplier Deviation allows a supplier to
request an exception to specification before material
is shipped. This eases the pressure on your quality
department to accept the material and increases efficiency.

Inefficient Paper Forms System: A paper-based forms
process can be plagued with inefficiency and such issues
as: filling out the wrong form, not completing the right form,
and sending the form to the wrong person.
Cost-effective Automated System: MasterControl
automates forms-based processes such as Supplier
Deviation and offers best-practice features that
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.

phone: 800.825.9117 web: www.mastercontrol.com email: info@mastercontrol.com

 MasterControl Supplier Deviation™

Poor Data Capture: Forms are designed to gather
accurate and complete information critical in compliance.
With paper forms, the onus lies with the operator to input
accurate and complete information, and then for an analyst
to accurately transfer this information to a spreadsheet or
other analysis tool.
Accurate Data Capture: In creating new forms or
improving existing ones, companies can use a variety of
field formats for accurate and accelerated data collection.
With a click of a mouse, a user can select common
responses keyed in the form fields that allow a list of data
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
forms-based processes (audit findings, corrective action,
etc.), making continuous improvement almost impossible.
For example, if the customer complaint process is not
linked to the corrective action process, a critical complaint
may languish indefinitely before it can be acted upon and
remediation is initiated.
Connected Processes: MasterControl integrates different
quality processes for more effective and efficient quality
management. For example, a CAPA form can be launched
directly from an OOS form, connecting one process to the
next. Relevant information will be automatically entered
into the new form, reducing data entry and avoiding
mistakes common in manual transfer of information.

Features and Benefits

• 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).

© 2009 MasterControl Inc. All rights reserved.

phone: 800.825.9117 web: www.mastercontrol.com email: info@mastercontrol.com