21 CFR Part 11: Complete Guide to International Computer - download pdf or read online

By Orlando López

ISBN-10: 084932243X

ISBN-13: 9780849322433

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 globe desktops validation rules. the writer introduces helping applied sciences resembling 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 based top-down process. He covers sensible purposes of caliber coverage and engineering innovations as they relate to the advance of platforms healthy to fulfill consumer and regulatory requirements.

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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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