Defining the scope, objectives, and strategy for successful implementation of a facility or system project to align with quality and organizational goals.

Identifying potential risks to quality, performance, and safety, prioritizing mitigation efforts based on the severity and the likelihood of the resulting impact.

Ensuring systems, equipment, and facilities are correctly installed and operational according to design specifications. While typically performed prior to formal validation, commissioning and startup efforts may be leveraged with proper project planning and risk management.

Confirming that critical systems, utilities, processes, and environments are functioning as intended prior to production use. Pre-operational verification may take place in conjunction with other CQV lifecycle activities.

Verifying that equipment meets both the design and functional testing at the supplier’s site before delivery and at the client’s site after delivery, respectively.

Providing structured evidence that systems and processes consistently perform towards its intended purpose to support product quality and reliability. Validation lifecycle documentation may consist of documents such as requirements, protocols, assessments, and reports and normally take a quality risk management approach.

Managing the proper retirement of systems or equipment with proper documentation and procedures to preserve data and historical process integrity.