Validation Documentation

Testing Documentation
Documentation, such as protocols or test scripts, should be developed that specifies how
the validation study will be conducted. Testing documentation should contain or
reference the following information, as applicable:
o Title and unique identification number;
o References to related documents such as the validation planning document
and SOPs;
o Objectives and scope of the study;
o Prerequisites (e.g. qualified equipment for process validation or
Installation Qualification with no major deviations prior to Operational
Qualification)
o Clear, precise definition, or reference to same, of the system or process to
be validated, for example:
o Summary and/or process flow diagram of critical processing steps
included in the study;
o The Master Manufacturing instructions or Device Master Record to be
validated (i.e., that to be used in preparation of validation lots or batches);
o The critical process parameters (CPPs) for the process steps being
validated;