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Tag: Part 11 Compliance

Risk management of existing(Legacy) systems for FDA Compliance

Posted on April 27, 2024April 27, 2024 by admin

Risk management of existing systems is just as important as for new systems. The question is not: how old is the system? But rather: what is it being used for? You may also ask yourself what happens if something goes wrong and what is the likelihood that something does go wrong.  The main difference for Read more about Risk management of existing(Legacy) systems for FDA Compliance[…]

Posted in Articles & Best Practices, Healthcare Best Practices, Med Device Best Practices, Pharma Best PracticesTagged Documentation Compliance, Existing Systems, FDA Compliance in Legacy Systems, High-Level Evaluation, Legacy System Risks, Legacy Systems, Part 11 Compliance, Regulatory Observations, Risk management, System Criticality, System Testing Requirements, System Upgrade Considerations, system validation, Vendor Support

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