The Connection between Regulatory Requirements and Supplier Audit Software System
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:
- Organizations must verify that purchased products and services meet specific purchase requirements that were agreed upon when the vendor was initially selected.
- Organizations must evaluate and select suppliers based on their ability to provide products and services that meet the organization's requirements.
In accordance with 21 CFR 820.50 and 820.80 the FDA Guide to Inspections of Medical Device Manufacturers states that:
Particular attention should be paid to custom components and those components that would require special handling or storage to maintain their integrity. Be wary of situations where a manufacturer has relaxed specifications because the supplier could not meet the original specifications.
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.
How Supplier Audit Software Systems Can Help You Meet Regulatory Demands
Comprehensive, integrated supplier audit software can help companies that are actively working toward meeting supplier audit compliance requirements by offering features such as:
- Maintenance of all supplier status data and essential quality information in a central, secure repository. This information may include supplier approval status, contact information, audits, non-conforming material reports, CAPA reports, contracts, approved goods and services, supplier ratings, links to analytics reports, and so forth.
- Ready access to analytics that can be used to build reports in order to filter and trend data that has been collected about suppliers. Online access to such information makes simplifies this goal immensely.
- An interface that makes it easy for users, auditors, reviewers, and the like to access all documentation and records related to each of the organization's suppliers. Some supplier audit software systems go even further to facilitate compliance by providing user-friendly interfaces that display supplier status fields for each supplier to indicate whether or not a particular vendor has been approved.
MasterControl's Supplier Audit Software System
The MasterControl Supplier™ software solution offers companies accelerated compliance with an extensive array of regulatory standards such as:
- Current Good Manufacturing Practices (cGMPs)
- ISO 9001:2000
- IOP Standards
- UN Supplier Code of Conduct
- British Retail Consortium (BRC) Global Standards
- And more
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:
- A single location for accessing all supplier quality data and documentation - from non-conformances and audit observations to contracts and service level agreements, and everything in between
- The capability to manage approvals at the individual part or services level
- Organization-wide access to AVLs as they are updated in real time
- Access to supplier-focused quality event solutions, such as MasterControl Supplier Corrective Action (SCAR)™, MasterControl Supplier Deviation™, and MasterControl Supplier Scorecard™
- Seamless integration with complementary quality solutions such as MasterControl Audit™, MasterControl CAPA™, and MasterControl Risk™
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:
- Approval status
- Contact information
- Recent supplier audits
- CAPA reports
- Approved parts lists
- Supplier ratings
- Links to analytics reports
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.