One of the biggest computer validation challenges facing pharmaceutical manufacturers is the large corporate system. This book provides practical information and advice on good IT practice and validation principles. Written by experts, it includes case studies on EDMSs, EAM systems, LIMSs, and MRP II systems. Topics include paper- and peopleless plants, GxP compliance, integrating manufacturing systems, electronic signatures, validating asset management systems, enterprise/manufacturing planning systems, lab information management systems, and Local & Wide Area Networks, compliance for IT Infrastructure, IT system maintenance and support, and auditing suppliers, software Integrators, and hardware manufacturers.
Validating Corporate Computer Systems
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2 of 2 people found the following review helpful:
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Useful case Studies,
By A Customer
This review is from: Validating Corporate Computer Systems: Good IT Practice for Pharmaceutical Manufacturers (Hardcover)
Very good chapter on operation and maintenance of large IT systems for FDA compliance. Latest GAMP case study on IT infrastructure. Excellent case study on networks.
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Inside This Book
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First Sentence:
Paperless operations have been heavily promoted in recent years within the pharmaceutical industry. Read the first page Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
analytical equipment interfaces, supplier acceptance testing, paperless operation, validation life cycle, bespoke code, hardware design specification, computer systems validation, object brokering, corporate computer systems, qualification strategy, pharmaceutical organization, validated status, software integrators, validation manager, computer validation, validated state, software design specification, validation committee, validation status, regulatory expectations, maceutical manufacturer, bespoke software, validation documentation, validation policy, pharmaceutical enterprise Key Phrases - Capitalized Phrases (CAPs): (learn more)
Validation Plan, Validation Report, Installation Qualification, Procedural Pharmaceutical, Functional Specification, United Kingdom, Operational Qualification, Buffalo Grove, Technological Supplier, User Requirements Specification, Good Manufacturing Practice, Performance Qualification, Interpharm Press, Code of Federal Regulations, Project Quality Plan, United States, European Union, Validation Master Plan, Design Qualification, Monitoring Plan, Putting Principles, Functional Design Specification, Manufacturing Resource Planning, Medicines Control Agency, Body of Knowledge New!
Books on Related Topics | Concordance | Text Stats Browse Sample Pages:
Front Cover | Table of Contents | First Pages | Index | Back Cover | Surprise Me!
Paperless operations have been heavily promoted in recent years within the pharmaceutical industry. Read the first page Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
analytical equipment interfaces, supplier acceptance testing, paperless operation, validation life cycle, bespoke code, hardware design specification, computer systems validation, object brokering, corporate computer systems, qualification strategy, pharmaceutical organization, validated status, software integrators, validation manager, computer validation, validated state, software design specification, validation committee, validation status, regulatory expectations, maceutical manufacturer, bespoke software, validation documentation, validation policy, pharmaceutical enterprise Key Phrases - Capitalized Phrases (CAPs): (learn more)
Validation Plan, Validation Report, Installation Qualification, Procedural Pharmaceutical, Functional Specification, United Kingdom, Operational Qualification, Buffalo Grove, Technological Supplier, User Requirements Specification, Good Manufacturing Practice, Performance Qualification, Interpharm Press, Code of Federal Regulations, Project Quality Plan, United States, European Union, Validation Master Plan, Design Qualification, Monitoring Plan, Putting Principles, Functional Design Specification, Manufacturing Resource Planning, Medicines Control Agency, Body of Knowledge New!
Books on Related Topics | Concordance | Text Stats Browse Sample Pages:
Front Cover | Table of Contents | First Pages | Index | Back Cover | Surprise Me!
Citations (learn more)
10
books
cite this book:
See all 10 books citing this book
- The GCP Harmonization Handbook by Donald E. Maynard in Back Matter
- Audit by Mail: Time and Cost Effective GMP Audit Tool by John Lyall in Back Matter
- International Clinical Trials: A Guidebook and Compendium of National Drug Laws, Two-Volume Set by Dominique Brunier in Back Matter
- Computer Validation Compliance: A Quality Assurance Perspective by Mary Ellen Double in Back Matter
- Quality Assurance Compliance: Procedures for Pharmaceutical and Biotechnology Manufacturers by Ira C. Peine in Back Matter
See all 10 books citing this book
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