By Orlando López

overlaying regulatory requisites stipulated via 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 rules. the writer introduces assisting applied sciences comparable to encryption and electronic signatures and locations regulatory compliance in the context of caliber insurance. He demonstrates the significance of integrating validation actions into the procedure lifecycle utilizing a based top-down method. He covers functional functions of caliber insurance and engineering strategies as they relate to the improvement of platforms healthy to satisfy 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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