EduQuest.net

Validation

Validation, from the regulatory perspective, is defined as establishing documented evidence that provides a high degree of assurance that a system meets predetermined specifications and consistently produces the desired outputs. Thus, the primary regulatory risks associated with validation are that the validation documentation will be incomplete or that the “validated state” achieved by the end of the project will be difficult to maintain. We address these potential risks by assuring the presence of: (1) clearly defined and articulated acceptance criteria; (2) check-lists for use by the validation project team; (3) a workable corrective action system; (4) a program and philosophy of prevention as well as corrective actions; and (5) effective maintenance procedures and processes for maintaining a validated state.

Our goal is to work with everyone involved in a project. Each person on the team plays a role in validation, and it is through each team member’s understanding and acceptance of their role that validation is properly achieved and sustained. EduQuest provides the leadership and oversight to assure that our clients’ validation goals are met.