what is the diffirence between deviation and change control?
at what situations we can raise the deviation and change
control
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Answer Posted / arvind mishra
A process that ensures that changes to materials, methods,
equipment and software are properly documented, validated,
approved and traceable.The process includes evaluation to
determine whether validation is required and the level of
validation required.
Deviation is a process in which we have to perform a task
that is not mentioned in the SOP,deviations are two types
one is planned deviation and
another is un planned deviation. Planned deviations are two
types one is tempery and another is permenent. tempery
deviations are approved by QA (for a limited period) then
proceed. permanent deviations are must be reviewed by
releated departments and approved by QA through change
control procedure.
Conclusion;- When deviation is permanent then approved by QA
through change control procedure.
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