If your company uses products or services from suppliers that could potentially affect product quality, you also need a supplier audit software system to conduct effective supplier audits according to regulatory guidelines.
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Supplier audits are particularly essential in industries governed by regulatory mandates such as those issued by ISO, the U.S. Food and Drug Administration (FDA), and similar regulatory bodies. Two primary elements of the ISO 9001:2000 standard are particularly relevant to supplier audit software systems' ability to appropriately track and offer access to supplier data:
In accordance with 21 CFR 820.50 and 820.80 the FDA Guide to Inspections of Medical Device Manufacturers states that:
Although CPG 7151.02 prohibits FDA access to a company's supplier audit reports, the documentation and procedures that indicate conformance with 21 CFR 820.50, Purchasing Controls, and 21 CFR 820.20(3)(c), Management Reviews, are subject to FDA inspection. For all the reasons mentioned above, an effective supplier audit software system is highly recommended to ensure that regulatory requirements can be adequately met.
Comprehensive, integrated supplier audit software can help companies that are actively working toward meeting supplier audit compliance requirements by offering features such as:
The MasterControl Supplier™ software solution offers companies accelerated compliance with an extensive array of regulatory standards such as:
Regulatory standards such as the aforementioned recommend that companies document all supplier- and customer-related activities that may lead to an actual or potential nonconformance. To respond to such guidelines, the MasterControl Supplier solution has been specifically engineered to facilitate and accelerate compliance by providing users with an approved vendor list (AVL) that is easy to maintain. The MasterControl system offers an easy-to-use interface for accessing all supplier-related documentation and records.
MasterControl's supplier audit software system gives users:
The MasterControl solution tracks and stores information derived from supplier audits automatically just as it does other supplier-related activities such as non-conformance reports, CAPAs, and supplier deviations. The MasterControl supplier audit software system maintains supplier audit, status, and quality information centrally and securely and it allows users to supervise suppliers on the AVL on an ongoing basis. It also supports the successful fulfillment of a number of qualifications, such as supplier surveys, supplier audits, and process validation.
MasterControl maintains all the necessary information about suppliers including:
MasterControl's supplier audit software system also offers users a variety of functionality options such as the ability to create new suppliers within the system, the capability to view lists of suppliers, enhanced search functionality, and simplified processes for importing supplier information. MasterControl features unparalleled reporting capabilities as well. The MasterControl system can produce reports for tracking and trending quality events such as supplier audits, CAPAs, and deviations.
For more details about supplier audits and supplier audit software systems, contact a MasterControl representative or call 800-825-9117.