WEST CHESTER, Pa., Oct. 1, 2003 (PRIMEZONE) -- The Food and Drug Administration (FDA) has been cracking down on the way pharmaceutical and biotech companies do business by requiring them to comply with many new regulations. In order to bring companies up to speed, author Stephan Robert Goldman introduces his new book, Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry (now available through 1stBooks).
"Creating a state of compliance with FDA regulations including 21 CFR Part 11, 'Electronic Records, Electronic Signatures,' is a daunting task," Goldman says.
To help companies learn how to comply, Goldman offers Handbook of Computer and Computerized System Validation as a "SOP-centric (Standard Operating Procedure)" explanation how companies can achieve the daunting task of compliance. This handbook follows FDA guidelines and "Best Industry Practices" in defining the roles, responsibilities and requirements of computer and computerized system validation for the pharmaceutical, biotechnology and medical device industries.
Each chapter of Handbook of Computer and Computer Systems Validation is complete and detail oriented. Chapters detail the requirements for standard operating procedures and protocols for user requirements, functional requirements, design specifications, installation qualification, operational qualification and performance qualification. The author also prescribes assessment and validation gap analysis methods to determine a company's state of compliance with current regulations.
For companies effected by this regulations, Handbook of Computer and Computer Systems Validation is an indispensable text to bridge the gap.
A senior compliance director and consultant specializing in 21 CFR Part 11 training, assessment, remediation, validation and project management, Goldman specializes in providing sustainable compliance in the regulated pharmaceutical environment. With a background in electrical engineering, manufacturing, defense, pharmaceutical and biotechnology, Goldman feels he is able to relate to most types of business operations. Handbook of Computer and Computerized Systems Validation is his first book.
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