Reviews and Letters ...
About our CAPA system for a medical device manufacturer...
This application supplies a critical piece in an organization’s Quality Management System (QMS). It implements Corrective and Preventive Action (CAPA) as the pivotal component in the cluster of activities
organization’s goal of continual improvement.
From the Customer:
“We have worked with the [CAPA] software for over 3 years and have found it extremely valuable in terms of meeting both our ISO 9000 and
FDA/MDD quality systems requirements. Perhaps more important, the CAPA system, because it is integrated with our accounting and customer contact systems contributes significantly to our operating procedures and thus has paid for itself many times over in terms of both operating efficiency and document control.
Over the last three years we have been audited a number of times by ITS, our quality system registrar, the FDA, and
OSHA. In every case the auditors have described our CAPA system as the best and most effective they have
From a senior independent auditor:
“Mr. Carpenter’s CAPA system ... not only meets the requirements
of the standard, but also serves as a focal point for product and service
improvement. In this respect it stands head and shoulders above most
systems I have seen in place in small and medium-sized companies”
About our Mental Retardation MIS system for the State of Maine ...
This application models the delivery of community-based services for
persons with mental retardation. Developed on a pre-Windows platform and
migrated to Windows, it served approximately 5000 of Maine’s citizens for a period of nine years
before it was migrated again to become part of an enterprise-wide
Web/Java/Oracle application, a project to which Commonwealth Software
From an independent reviewing organization, The Center for
“One of our first and foremost findings:
DMHMRSAS’ MIS is elegant, it
is compact in terms of the equipment needed to run it, it was designed quickly
and implemented quickly, it targets the intent of the Community Consent Decree
with regard to tracking ‘needs’ and ‘unmet needs,’ ... It is our strong opinion that the creators and supporters of
the MIS should be congratulated for their speed, dedication and diligence. ... We believe that
the small, entrepreneurial, flexible, and friendly elements of this MIS should
be preserved and supported in the future...
“This MIS should be treasured and
preserved. It is an admirable accomplishment, and places Maine’s DMHMRSAS far
ahead of most state systems in its ability to track and examine service user
characteristics, services needed and services received.”