Home Analytic Chemistry • New PDF release: 21 CFR Part 11: Complete Guide to International Computer

New PDF release: 21 CFR Part 11: Complete Guide to International Computer

By Orlando López

ISBN-10: 084932243X

ISBN-13: 9780849322433

overlaying regulatory requisites stipulated by way of the FDA, this e-book delineates the association, making plans, verification, and documentation actions and procedural controls required for compliance with around the globe computers validation laws. the writer introduces assisting applied sciences comparable to encryption and electronic signatures and areas regulatory compliance in the context of caliber coverage. He demonstrates the significance of integrating validation actions into the procedure lifecycle utilizing a established top-down procedure. He covers sensible functions of caliber insurance and engineering options as they relate to the improvement of platforms healthy to satisfy consumer and regulatory requirements.

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Orlando López's 21 CFR Part 11: Complete Guide to International Computer PDF

Masking regulatory necessities stipulated by means of the FDA, this ebook delineates the association, making plans, verification, and documentation actions and procedural controls required for compliance with around the world desktops validation laws. the writer introduces aiding applied sciences comparable to encryption and electronic signatures and areas regulatory compliance in the context of caliber coverage.

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21 CFR Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry by Orlando López


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