Statement of Conformance to ISO 13485 and US CFR (FDA) 21 CFR Part 11 & 820


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 Topics

Q & A QMSCAPA, ISO 13485 and US FDA 21 CFR

Comparison of QMSCAPA, ISO 13485 and US FDA 21 CFR


ISO Internal Auditor Training Course

Online Internal Auditor Training Course ISO Management Systems

Click here for Details


+1 800 644 2056


Published by ABCI Software Solutions | ABC ISO Consultants

Online & Onsite ISO Auditor and Awareness Training | ISO Certification Services | ISO Resources

Copyright © Access Business Communications, Inc.