Compliance with ASTM E2500 |
The current resource intensive manual and/or hybrid validation processes, coupled with the introduction of Risk-based validation
approaches such as ASTM2500 and FDA’s Quality by Design initiatives make the adoption of electronic validation management
systems inevitable. Adopting ValGenesis to implement ASTM E2500 standards in the corporate validation process helps to enforce the
risk-based approach, removes the ine ciencies that plague paper-based validation process and enforces polices and procedures for
quali cation processes that are typically buried in procedures and policies documents. In addition, ValGenesis helps to enforce consistency,
enhances compliance and reduces the cycle time of the corporate validation process.
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