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

By Orlando López

ISBN-10: 084932243X

ISBN-13: 9780849322433

overlaying regulatory standards stipulated via the FDA, this booklet 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 helping applied sciences reminiscent of encryption and electronic signatures and areas regulatory compliance in the context of caliber insurance. He demonstrates the significance of integrating validation actions into the method lifecycle utilizing a based top-down technique. He covers functional purposes of caliber insurance and engineering innovations as they relate to the improvement of structures healthy to fulfill person 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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