Download 21 CFR Part 11: Complete Guide to International Computer by Orlando López PDF

By Orlando López

overlaying regulatory necessities stipulated via the FDA, this e-book delineates the association, making plans, verification, and documentation actions and procedural controls required for compliance with around the world computers validation laws. the writer introduces helping applied sciences similar to encryption and electronic signatures and locations regulatory compliance in the context of caliber coverage. He demonstrates the significance of integrating validation actions into the approach lifecycle utilizing a dependent top-down technique. He covers sensible functions of caliber coverage and engineering innovations as they relate to the advance of platforms healthy to satisfy consumer and regulatory requirements.

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Read or Download 21 CFR Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry PDF

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