ABSTRACT
Computerized systems validation (CSV) represents one of several foundational quality systems necessary to ensure the overall integrity of the biopharmaceutical manufacturing, testing, packaging, and holding process-and thereby meet the ultimate goal of ensuring biopharmaceuticals provided to patients are safe and effective. CSV strategies must meet the needs of a competitive business environment characterized by complex and rapidly changing technologies. As such, CSV strategies should be streamlined, yet effective, and tailored to the speciŒc risks posed by individual types of computerized systems and their use in the intended business process and computing environment. An appropriate CSV program adds value to biopharmaceutical manufacturing by ensuring that computerized systems perform consistently
11.1 Introduction .................................................................................................. 313 11.2 Hypothetical Risk Models for Automation and Validation .......................... 315 11.3 Good Documentation Practices for Electronic Data-21 CFR Part 11 ....... 319 11.4 Creating a Corporate Culture for Computerized Systems Compliance ....... 323 11.5 Validation of Individual Computerized Systems .......................................... 335
11.5.1 Risk Assessment and Management .................................................. 337 11.5.2 Planning Phase / Personnel Responsibilities for CSV ...................... 339
11.5.2.1 System Owner and System Users ......................................340 11.5.2.2 Information Technology (IT) and Information
Systems (IS) .......................................................................340 11.5.2.3 Quality Assurance and Compliance ..................................340
