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MasterControl Supplier Deviation™

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

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 speci cations. Under very speci c circumstances,exceptions from the written speci cations 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 andcontrolling data critical to compliance. MasterControl Supplier Deviation creates a formal process where suppliers canrequest an exception to written speci cations. Materials are shipped only after the appropriate individuals have reviewedand approved the request and provided proper justi cation.

The solution offers exibility in terms of design, routing, and user and security roles to adjust to the way you work. Itprovides advanced tracking functionality, incorporates escalation, and offers best-practice features that prompt userswith selected data to reduce data entry and avoid mistakes common in manual data entry. Captured data is stored in anODBC-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 andmaintaining forms-based processes.

Challenges MasterControl SolutionUnavailability of Objective Data on Supplier Performance: In environments without a formalized or with a paper-based supplier deviation process, objectivedata 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 everyrequested supplier deviation. This data can be analyzed indetail and serve as an input to your supplier managementprogram.

Arrival of Nonconforming Material at your LoadingDock: Without a formalized supplier deviation program,suppliers may ship rather than investigate in case of “minor” non-conformances. Processing at the loading dockand returning unacceptable material after undergoing theincoming QC process creates unnecessary costs anddelays.

Communication of Issues before Material is Shipped: MasterControl Supplier Deviation allows a supplier torequest an exception to speci cation before materialis shipped. This eases the pressure on your qualitydepartment to accept the material and increases ef ciency.

Inef cient Paper Forms System: A paper-based forms

process can be plagued with inef ciency and such issuesas: lling 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 thatprompt users with selected data. It automates routing,noti cation, 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 veri cation) from virtually anywhere.

8/8/2019 MasterControl Supplier Management Software

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MasterControl Supplier Deviation™

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

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 analystto 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

eld formats for accurate and accelerated data collection.

With a click of a mouse, a user can select commonresponses keyed in the form elds that allow a list of dataoptions previously entered. This helps ensure data isentered correctly into the form. Fields can also be set up tocalculate data using simple or complex math operations.

Disconnected Processes: Manual systems don’t connectforms-based processes (audit ndings, corrective action,etc.), making continuous improvement almost impossible.For example, if the customer complaint process is notlinked to the corrective action process, a critical complaintmay languish inde nitely before it can be acted upon andremediation is initiated.

Connected Processes: MasterControl integrates differentquality processes for more effective and ef cient qualitymanagement. For example, a CAPA form can be launcheddirectly from an OOS form, connecting one process to thenext. Relevant information will be automatically enteredinto the new form, reducing data entry and avoidingmistakes common in manual transfer of information.

Features and Bene ts

Best Practice Form:• A pre-con gured, multi-page form prompts MasterControl users to collect and track all relevantdata and guides them through the process while allowing responsible personnel to make appropriate decisions withthe information. The form is automatically distributed to designated personnel on a pre-determined route and canescalate if not processed in a timely manner.

Best-Practice Process:• The MasterControl Supplier Deviation module incorporates a three-step process that guidesusers through the process, beginning with the Supplier Deviation Request through Supplier Deviation Disposition andQA Disposition.

Analytics Reporting Tool:• MasterControl includes a built-in tool that comes with a standard set of pre-con guredreports that can be adjusted and customized by the end user. Supplier Deviations can be analyzed by product,speci cation, category, disposition, etc. These data-mining capabilities can give important insight into systemic qualityissues and serve as an input to supplier evaluations.

Audit Trail and Electronic Signatures:• MasterControl provides reporting, electronic signature, and time-stampedaudit 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 areenabled to seamlessly initiate the change control process to update speci cation or other internal documents asrequired.

About MasterControlMasterControl 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 softwarevalidation products and services, MasterControl drives down the total cost of ownership and enables customers to extendtheir investment across the enterprise. Hundreds of companies, including 50 percent of the top 20 pharmaceuticalenterprises, currently use MasterControl solutions for easier compliance, faster validation, and better processmanagement. 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).

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