Statement of Conformance to ISO 13485 and US CFR (FDA) 21 CFR Part 11 & 820
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About ACCESS BUSINESS COMMUNICATIONS, INC. (ABCI) ABCI produces software solutions that enable non-regulated and regulated companies improve the quality of their products through providing collaborative tools for monitoring quality objectives, process efficiency and corrective actions for non-conformances.
The intended use and general purpose of its QMSCAPA™ software is to aid in the administrative management of quality management systems, including AS9100 for the Aerospace industry and ISO 13485 for Medical Device industry.
QMSCAPA™ is an off-the-shelf software that’s easy to use, configure, install, implement, and validate. The different QMSCAPA™ modules — Document Control Index, integrated forms, CAPA logging, Training Programs, Non-conformances, Risk Management, and Records Control Index — can be used as standalone applications or as an integrated system under a single Internet-based portal using Microsoft’s Remote Desktop Services.
ABCI offers real-time support services that include hands-on software training, installation assistance, optional validation services, and continuing customer and technical support. The QMSCAPA™ solution helps medical device manufacturers’ quality processes stay compliant, connected, and complete.
Also, QMSCAPA is known for being easy to implement, easy to use and easy to configure.
Many users have found that QMSCAPA v1.34 offers an effective software solution to medical device manufacturers’ needs pertaining to compliance with 21 CFR Part 11 & 820 and ISO 13485. QMSCAPA solutions include:❑Audit Management ❑Corrective & Preventive Actions ❑Customer Feed-back ❑Document Control Index with Revision History and Authorized Approval Log ❑Management for Monitoring & Measuring Devices ❑Records Control Index with Records Approval Log ❑Risk Management and Risk Treatment Programs ❑Supplier Management ❑Training management.
Related TopicsQ & A QMSCAPA, ISO 13485 and US FDA 21 CFRComparison of QMSCAPA, ISO 13485 and US FDA 21 CFR |
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