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As an analytical Chemist
once remarked, that cGMP is all about making Robots out of human beings.
cGMP compliance has routinely focused on evolving processes that
are repeatable. ADAPT process evolution model goes beyond the
cGMP 'threshold' from being routine ‘Repeatable’ level to an
ultimate level wherein the processes become ‘Thinking’
processes. Figure, provides an overview of the ADAPT evolution
model. The system design also provides an ideal framework for
providing ‘true’ integration of the knowledge bases across the
organization ADAPT provides a framework based on which
organizational work practices continuously improve the
capability of its workforce.
It considers that people and their
knowledge-base as leverage points and focuses on developing them
continuously. It sets the foundations of an evolutionary
improvement path from ad hoc, inconsistently performed practices
to mature, disciplined development of knowledge, skill and
motivation of workforce.
The skill inventory keeps track of
who has been trained on a process and the Out-of-Specification
Investigations (OSS) triggered by a particular team member. One
of the important aspects of cGMP compliance motivating team
members as to how to cost efficiently improve the quality of the
processes beyond current levels !

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