RISK001 Risk Management Policy (RiskVal^SM)

The purpose of this policy is to define risk principles and establish the policy for the formal management of risk related to products or any item that could potentially impact the purity, potency, quality, safety, or effectiveness of a product. Items that are used for GXP functions, and/or to generate, store or retrieve electronic quality records are also included. It is the policy that governs the management of risks associated with computer system failures.