Pharmaceutical Science

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EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP

Orlando Lopez
April 06, 2015

Good Manufacturing Practice (GMP) ensures medicinal products are produced consistently and controlled to the quality standards appropriate for their intended use and as required by product specifications or marketing authorization. Annex 11 details the European Medicines Agency (EMA) GMP...

Introduction to Software for Chemical Engineers

Mariano Martín Martín
July 01, 2014

The field of chemical engineering is in constant evolution, and access to information technology is changing the way chemical engineering problems are addressed. Inspired by the need for a user-friendly chemical engineering text that demonstrates the real-world applicability of different computer...

Pharmaceutical Computer Systems Validation: Quality Assurance, Risk Management and Regulatory Compliance

Guy Wingate
February 23, 2010

Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements...

Dendrimer-Based Nanomedicine

Istvan Majoros, James R. Baker, Jr.
May 31, 2008

In recent decades, dendrimers — free-shaped synthetic macromolecules — have garnered a great deal of scientific interest because of their unique molecular nanostructure. Used in a variety of scientific applications, dendrimers are now widely regarded as a safer, more precise and more effective way...

Validating Pharmaceutical Systems: Good Computer Practice in Life Science Manufacturing

John Andrews
August 03, 2005

All too often, the words "computer validation" strike terror into the hearts of those new to the process and may even cause those familiar with it to tremble. Validating Pharmaceutical Systems: Good Computer Practice in Life Science Manufacturing delineates GCP, GLP, and GMP regulatory requirements...

21 CFR Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry

Orlando López
January 15, 2004

Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance with worldwide computer systems validation regulations. The author introduces supporting technologies...

Computer Systems Validation: Quality Assurance, Risk Management, and Regulatory Compliance for Pharmaceutical and Healthcare Companies

Guy Wingate
December 18, 2003

Both pervasive and ubiquitous, computerized systems are now an integral component of every corporate strategy in pharmaceutical and healthcare companies. However, when technology is combined with high-risk public safety projects or the production and control of life-saving medicines or devices, it...

Testing Computers Systems for FDA/MHRA Compliance

David Stokes
November 25, 2003

There is no substitute for extensive testing when it comes to IT systems. Recognition that problems are easier and cheaper to fix before the system is in use (rather than after), has turned testing into a cost-effective tool. However, when developing computer systems for pharmaceuticals...

Validating Corporate Computer Systems: Good IT Practice for Pharmaceutical Manufacturers

Guy Wingate
May 31, 2000

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...

Automation and Validation of Information in Pharmaceutical Processing

Joseph F. deSpautz
June 16, 1998

This thoroughly authoritative work furnishes organizational, technological, validation, project management, and business perspectives on pharmaceutical information automation from industry and system automation professionals-demonstrating how to fulfill computer system validation requirements for...

Software Quality Assurance: A Guide for Developers and Auditors

Howard T. Garst Smith
June 30, 1997

Of all the audit functions faced by QA, software auditing is probably the most difficult because of the need to know and understand the intricacies of the processes being audited. In addition, auditors must be familiar with and understand the implications of the international and national standards...

Computer Techniques in Preclinical and Clinical Drug Development

Robert C. Jackson
July 23, 1996

It is estimated that 80 to 90% of drugs under development never make it to the marketplace due to insufficient clinical activity, unacceptable toxicity, rapid appearance of drug resistance, or other factors that should be, at least partially, predictable from preclinical testing. This new text asks...

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