March 21, 2021

SOP For Auditing Computer Systems – FDA Compliance

It is very important to have your Commercial Off-The-Shelf Systems audited throughout all lifecycle phases as applicable to users of systems. Critical key processes should be assessed for compliance with regulations and internal standards and procedures. This SOP will help to prepare, conduct and follow up on audits of computer systems. It includes Step-by-step instruction on how to prepare, conduct and follow up on audits of computer systems. With two example tables for easy documentation. This document provides information on Responsibilities, Frequency of use & Retirement principles

The Scope of this document on SOP for Audit does not include any software development activities or supplier audits.

Product ID : KTCP233

Format: Editable Word document

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