Pharmaceutical Science

Computer Software

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Introduction to Software for Chemical Engineers, Second Edition

2nd Edition

Mariano Martín Martín
July 02, 2019

The field of Chemical Engineering and its link to computer science is in constant evolution and new engineers have a variety of tools at their disposal to tackle their everyday problems. Introduction to Software for Chemical Engineers, Second Edition provides a quick guide to the use of various...

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

1st Edition

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...

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

2nd Edition

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

1st Edition

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...

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

1st Edition

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

1st Edition

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...

Automation and Validation of Information in Pharmaceutical Processing

1st Edition

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

1st Edition

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...

Validation of Computerized Analytical Systems

1st Edition

Ludwig Huber
May 31, 1995

Validation of Computerized Analytical and Networked Systems provides the definitive rationales, logic, and methodology for validation of computerized analytical systems. Whether you are involved with formulation or analytical development laboratories, chemical or microbiological quality control...