By Orlando López

ISBN-10: 084932243X

ISBN-13: 9780849322433

protecting regulatory specifications stipulated by means of the FDA, this e-book delineates the association, making plans, verification, and documentation actions and procedural controls required for compliance with world wide computers validation rules. the writer introduces helping applied sciences equivalent to encryption and electronic signatures and areas regulatory compliance in the context of caliber insurance. He demonstrates the significance of integrating validation actions into the process lifecycle utilizing a dependent top-down process. He covers functional functions of caliber coverage and engineering recommendations as they relate to the advance of structures healthy to satisfy 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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