![]() FDA has recommended to use risk analysis techniques to allow manufacturers to put their time and effort in electronic data management and testing. As part of its recent initiative cGMPs for the twenty-first century “A Risk-Based Approach”, FDA has begun applying risk and impact assessment, including validation of Electronic Data Management System (EDMS), categorization of system components and supplier assessment as a validation strategy. Produced by the GAMP Forum, a technical subcommittee of ISPE, the GAMP Guide has been revised several times to accommodate changes to regulatory policies, best industrial practice requirements and in computer system validation. ![]() ABSTRACT The GAMP Guide is a voluntary set of guidelines created by industry leaders to help companies understand and meet cGMP regulations for automated systems. Vishal Gupta* Department of Pharmaceutics, JSS College of Pharmacy, JSS University, Sri Shivarathreeshwara Nagara, Mysuru, Karnataka, India. GAMP 5: A Quality Risk Management Approach to Computer System Validation Charan H.Y, N. ![]() Res., 36(1), January – February 2016 Article No.
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