is establishing documented evidence that provides a high degree of
assurance that a specific process consistently produces a product that meets its
11. List 4 things that must be included in the validation plan.
12. Match the QA term and the statement describing the QA term listed below:
Should be performed on regular
schedules and results should be
within established acceptable
3. Record Design
Results are used to determine if
critical control point practices are
within acceptable range.
Plan for when computer system is
Records may be kept on paper or
entirely electronically, provided they
can be easily retrieved.
Each form should have a title that
explains its intended use and should
include the name of the facility.