VALIDATION POLICY

• This policy applies to all items requiring validation, including facilities, utilities, equipment, processes, quality control methods, and computerized systems that could potentially impact the purity, potency, or quality of a product, or are used for GxP functions , and/or to generate, store, manipulate or retrieve electronic quality records.
• Policy is also stated for the purpose of validation, requirements of the validation process, the use of validated systems, retention of validation records, and supplier adherence to the policy.
• This document is best used by companies that use computer systems throughout the product life cycle , i.e., from research through production.

It Provides information on:

• Responsibilities.
• Method.
• Quality records.