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Good Computer Validation Practices

Source: Interpharm Press, Inc.
Common Sense Implementation
Interpharm Press, Inc.n Sense Implementation

This pragmatic text on computer systems validation examines the regulatory and practical issues involved in computer validation from a global perspective and provides a common sense approach to getting the job done. It combines the experiences and insights of an internationally respected group of computer systems specialists, healthcare industry professionals, and a regulator. It includes SOPs, checklists, and a wealth of usable tips and hints to make global computer validation a real, obtainable goal. Topics and concerns detailed in the text span the breadth of issues and influences imposed upon computer validation by worldwide Good Clinical, Laboratory, and Manufacturing Practice (GCP, GLP, GMP) requirements and provide a proven approach that meets the required regulatory and real-world needs of the healthcare manufacturing and research industries worldwide.

Chapters include:

  • Computer Validation Projects, Problems, and Solutions
  • International Regulations and Computer Systems: GCP/GLP/GMP
  • The Role of Senior Management in Computer Systems Validation
  • Documentation Practices and Principles
  • Validation Concepts and Key Terminology
  • Existing Computer Systems: A Practical Approach to Retrospective Evaluation
  • Data Center Management and Good Practices
  • Audit of External Software Vendors
  • Clinical Data Systems, GCP Validation, and CANDA
  • Computerized Systems Validation: Preparation for an FDA Bioprocess Inspection
  • Organization and Training for Validation
  • A Regulatory Perspective

This book is of essential concern to all management and staff involved with computer systems and software installation, qualification, validation, and auditing; and of particular relevance to Quality Assurance, Information Management, and Computer Systems professionals working in the healthcare manufacturing and research industries.

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