All qualification and validation activities should be planned and take the life cycle of facilities, equipment, utilities, systems, process and product into consideration.
The key elements of the site qualification and validation program should be clearly defined and documented in a Validation Master Plan (VMP) or equivalent document.
Decisions on the scope and extent of qualification and validation should be based on a justified and documented Risk Assessment.

Qualification activities should consider all stages from initial development of the User Requirements Specification (URS) through to the end of use of the facility, equipment, utility or system. The main stages are indicated below:

Each stage should be accompanied with appropriate documentation.

Facilities, equipment, utilities and systems should be evaluated periodically to confirm that they remain in a state of control (requalification), the specific time period should be justified and the criteria for evaluation defined.
Any planned changes (such as changes to utilities, systems, equipment; maintenance work; movement, etc.) which may affect the quality of the product, should be formally documented and the impact on the validated status or control strategy assessed. Stage (or stages) may require re-performing and all affected critical parameters should be re-confirmed.

Following the good documentation practices, we can help you with the customization of your own approach of creating a validation and qualification documentation, together with execution of all activities.