TABLE OF CONTENTS The validation plan provides the control of the whole of the validation effort. This is a roadmap for identifying the personnel who are involved, what they do and what documented evidence will be produced at which stage of the SDLC. The validation plan provides an organisation with the documented evidence of intent for CDS validation.
Section 4.5 of this document29 covers Plans:
The software validation process is defined and controlled through the use of a plan. The software validation plan defines what is to be accomplished through the software validation effort. Software validation plans are a significant quality system tool. Software validation plans specify areas such as scope, approach, resources, schedules and the types and extent of activities, tasks, and work items.
Some of the key points from this withdrawn draft guidance document are quoted below.23 A Validation Plan is a required document as the FDA considers that it is a
strategic document that should:
state what is to be done,
the scope of approach,
the schedule of validation activities, and
tasks to be performed.
The plan should also state who is responsible for performing each validation activity. The plan should be reviewed and approved by designated management .
Interestingly enough, there is no mention of a validation plan in the main text of the PIC/S guidance.31 The only reference comes in Table 6 of the Inspector s...
