Vendors providing goods and services to companies doing business in regulated environments are only qualified to supply specific products and services. As such, these suppliers must be accurately tracked on a company's approved vendor list (AVL). The AVL must be continually managed and monitored, a complex supplier management system that becomes exponentially more difficult as product designs and manufacturing processes change over time. Further complexities arise as increasing numbers of suppliers interface with or are managed by different departments and divisions across the company.
Centralized Location for All Supplier Quality Data: MasterControl Supplier provides a centralized repository for automating, maintaining and controlling all supplier quality data and documentation – from non-conforming material reports and audit observations to contracts and service level agreements. With MasterControl, you'll efficiently manage and monitor supplier status and ratings, records, CAPAs, AVLs and more.
Smoother Internal and External Audits: MasterControl Supplier automatically tracks and stores information derived from supplier management audits according to regulatory guidelines. With MasterControl, you'll securely store and maintain all information related to supplier management audits – including audit approval statuses, recent data derived from a supplier audit and links to quality assurance auditing and analytics report.
Improved Communication and Collaboration: MasterControl Supplier enables everyone involved in supplier management to stay connected across geographically dispersed locations, facilitating better communication and collaboration with suppliers to minimize complications relating to specifications, materials and parts needs. With MasterControl, you'll gain greater visibility into supplier quality and receive higher-quality materials and parts.
Holistic Supplier Management View: MasterControl Supplier provides a complete system for managing each supplier's quality information – approval status, non-conformances, deviations, SCARs and more – in a single place. By taking an integrated, holistic view of supplier management, rather than viewing each piece in isolation, MasterControl Supplier empowers you to execute and maintain a comprehensive and integrated supplier management system.
Quicker Response Time to Problems:MasterControl Supplier is a powerful automated mechanism for investigating and correcting supplier quality issues. With MasterControl, you'll streamline supplier-related corrective actions, better manage supplier CAPA information and be able to immediately respond to critical supplier quality issues that can quickly result in out-of-spec products, nonconforming materials or worse.
User-Friendly System: MasterControl Supplier is an intuitive, user-friendly system where all critical supplier statuses and documentation are contained in a centralized, easy-to-access location. With MasterControl, you'll be able to easily add or change data about suppliers, parts and services while leveraging a variety of robust features and functionality, including configurable templates and dynamic analytics reporting.
Top 10 Features of MasterControl Supplier
Supplier Qualification: Improve the management of all qualification documents and processes with routes, steps, high-risk initial audits and qualification audits to ensure continuity of supply, compliance and product quality. MasterControl enables you to manage initial lot inspects for certifying a supplier and to share supplier qualification data with personnel across multiple locations.
Document Management: Automate the entire lifecycle of your documents, including those pertaining to your supplier corrective action request (SCAR) process, and keep a single repository for all supplier quality-related processes and documentation. Automate critical processes with MasterControl and you will have all relevant information in one place and reduce document cycle time.
Approved Vendor Lists (AVLs): Effortlessly monitor and maintain AVLs, and make all records and documentation related to each supplier easily accessible to the relevant people. MasterControl enables you to automatically track and store each supplier's approval status and other critical supplier information, as well as ensure that AVLs are up-to-date and available across the organization.
Supplier Deviations: Allow suppliers to request exceptions to written specifications before material is shipped, and automate your data-collecting and -control processes. MasterControl helps ensure materials ship only after the appropriate people have reviewed and approved the request and provided proper justification. Capture and store supplier deviation data for in-depth analysis and reporting.
Supplier SCARS:Streamline all tasks related to your SCAR process, including routing, follow-up, escalation and approval of all documents. MasterControl improves your ability to collect and track data from the request phase through approval, and to connect the SCAR process with other quality processes (e.g., launch a SCAR form directly from a supplier deviation).
Supplier Parts and Services List: Simplify the process of adding and tracking parts and services. With MasterControl, you can add parts or services to your "approved to supply" list simply by linking them to a specific supplier. If a part is linked to an unapproved supplier, the link is disabled until the supplier is approved or reapproved.
Reporting / Scorecards: Ensure your suppliers maintain an acceptable level of quality by measuring their performance and rating them in a consistent fashion based on objective metrics. With MasterControl, you can collect and track data throughout the supplier scorecard process and create permanent records around supplier-related quality events, such as SCARs, supplier deviations and non-conformances.
Supplier Risk Management: Monitor supplier parts issues and make informed, risk-based quality decisions by gaining greater access to quality-related data. MasterControl automatically tracks and stores supplier information from audits, deviations, CAPAs and more, which can easily be compiled to help identify and mitigate risk, evaluate supplier performance and determine supplier quality ratings.
Supplier Audits: Automatically track and store information derived from supplier management audits. MasterControl securely stores supplier audit information, approval status and links to quality assurance auditing and analytics reports. You're able to maintain all supplier quality information in a centralized repository and make it easy to find suppliers that meet audit requirements.
Guest User Access: Enable trusted suppliers to connect to a secure online collaboration space. Securely bring supplier contacts directly into the system and give them practical interaction capabilities – for example, reviewing and offering edits against a specification, contract, quality agreement or other document type – without giving them a full-access account. Increase collaboration while maintaining security.
MasterControl Inc. and its partner, i4DM, are expanding their FDA project, serving as the QMS providers for a second FDA division. The two companies have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009. Now they will also serve as quality providers for the Division of Pharmaceutical Analysis, which is part of the FDA's Center for Drug Evaluation and Research.