Risk Management Policy (RiskVal)

ISO 14971 requires a policy for the management of risk. This policy document meets this requirement; it defines risk principles and establishes a policy for when formal risk management is required. This policy is the basic corporate policy for the management of risk associated with products (under development and in the market), manufacturing processes, equipment, computer systems, product distribution, etc. Requirements are defined for what needs to be included in the risk management process. 5 pages

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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

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