This publication explains how to use the NCP to find and retrieve checklists, and it also describes the policies, procedures, and general requirements for participation in the NCP.
Email comments to: [email protected](Subject: "Comments on SP 800-70")Comments due by: August 30, 2017.
Email comments to: [email protected](Subject: "Comments on SP 800-56C Rev. Using security configuration checklists to verify the configuration of information technology (IT) products and identify unauthorized configuration changes can minimize product attack surfaces, reduce vulnerabilities, and lessen the impact of successful attacks.
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Five 2-day In-person Interactive GMP, Part11 and Validation seminars available in America, Europe and Asia delivered by Dr. New Version 5 just released Now with Qualification of Virtual Networks With three audio seminars With 26 SOPs Online Audio Seminars come with 10 Best Practice guides for easy implementation New OECD Guide: Using Computer Systems in GLP Studies Understanding and Implementing the new OECD Guide for Computer Systems November 6, 2014 Computer System Validation: Step-by-Step With Case Studies and IQ, OQ, PQ Protocols for Easy Implementation September 2, 2014 Learning from Recent Warning Letters Related to Computer Validation and Part 11 With Clear Recommendations for Corrective and Preventive Actions Cost Effective Computer System Validation: Step-by-Step With Case Studies and IQ, OQ, PQ Protocols for Easy Implementation December 1, 2011 With compliance master plan, checklists, examples, audio seminar and 30 SOPs for easy implementation Click here for more info The CSV Package includes 36 SOPs. Computers are widely used during development and manufacturing of drugs and medical devices.
It is also requested by FDA regulations and guidelines through the overall requirement that "equipment must be suitable for it's intended use".
Therefore, computer system validation (CSV) should be part of any good development and manufacturing practice.