IT Pharma Validation Europe

CMMI - Capability Maturity Model Integration (GAMP 5) for development

Capability Maturity Model® Integration ([[CMMI]]) is a process improvement maturity model for the development of products and services. It consists of best practices that address development and maintenance activities that cover he product lifecycle from conception through delivery and maintenance.

This latest iteration of the model as represented herein integrates bodies of knowledge that are essential for development and maintenance, but that have been addressed separately in the past, such as software engineering, systems engineering, hardware and design engineering, the engineering “-ilities,” and acquisition. The prior designations of CMMI for systems engineering and software engineering (CMMI-SE/SW) are superseded by the title "CMMI for Development” to truly reflect the comprehensive integration of these bodies of knowledge and the application of the model within the organization. CMMI for Development (CMMI-DEV) provides a comprehensive integrated solution for development and maintenance activities applied to products and services.

The purpose of CMMI for Development is to help organizations improve their development and maintenance processes for both products and services. CMMI for Development is a collection of best practices that is generated from the CMMI Framework.1 The CMMI Framework supports the CMMI Product Suite by allowing multiple models, training courses, and appraisal methods to be generated that support specific areas of interest.

CMMI GAMP 5 Software Development Model

Figure: CMMI Project Documentation Model (click to enlarge)

Download the CMMI model here: CMMI for Development.pdf

The CMMI project work is sponsored by the U.S. Department of Defense (DoD), specifically the Office of the Under Secretary of Defense: Acquisition, Technology, and Logistics (OUSD/AT&L). Industry sponsorship is provided by the Systems Engineering Committee of the National Defense Industrial Association (NDIA).

Organizations from industry and government and the Software Engineering Institute (SEI) joined together to develop the CMMI Framework, a set of integrated CMMI models, a CMMI appraisal method, and supporting products. These organizations donated the time of one or more of their people to participate in the CMMI project.

The CMMI project team has been working to provide guidance that encourages process improvement in organizations with any structure. Since 1991, CMMs have been developed for a myriad of disciplines. Some of the most notable include models for systems engineering, software engineering, software acquisition, workforce management and development, and Integrated Product and Process Development.

Although these models have proven useful to many organizations, the use of multiple models has been problematic. Many organizations would like to focus their improvement efforts across the disciplines within their organizations. However, the differences among these discipline-specific models, including their architecture, content, and approach, have limited these organizations’ ability to focus their improvements successfully.

Further, applying multiple models that are not integrated within and across an organization is costly in terms of training, appraisals, and improvement activities. A set of integrated models that successfully addresses multiple disciplines and has integrated training and appraisal support solves these problems.

The CMM Integration project was formed to sort out the problem of using multiple CMMs. The CMMI Product Team’s mission was to combine three source models—(1) Capability Maturity Model for Software (SW-CMM) v2.0 draft C, (2) Electronic Industries Alliance Interim Standard (EIA/IS) 731, and (3) Integrated Product Development Capability Maturity Model (IPD-CMM) v0.98—into a single improvement framework for use by organizations pursuing enterprise-wide process improvement.

Developing a set of integrated models has involved more than simply adding existing model materials together. Using processes that promote consensus, the CMMI Product Team has built a framework that accommodates multiple disciplines and is flexible enough to support two different representations (staged and continuous).

Using information from popular and well-regarded models as source material, the CMMI Product Team created a cohesive set of integrated models that can be adopted by those currently using other CMMs, as well as by those new to the CMM concept.

CMMI version 0.2 was publicly reviewed and used in initial pilot activities. Following release of that version, improvement was guided by change requests from the public review, piloting organizations, and various focus group sessions. The CMMI Product Team evaluated more than 3,000 change requests to create CMMI version 1.0. Shortly thereafter, version 1.02 was released, which incorporated several minor improvements. As with any release, however, the opportunity for further improvement remained. Version 1.1 accommodates further improvements from early use as well as more than 1,500 change requests.

A company who wishes to do business with the DoD has to have a CMMI rating of at least level-3. Many additional government agencies and governments outside the US are using CMMI as a standard by which to judge subcontractors.

Find more information at the Software Engineering Institute web site:

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