Get Computer systems validation: quality assurance, risk PDF

By Guy Wingate

ISBN-10: 0849318718

ISBN-13: 9780849318719

Either pervasive and ubiquitous, automatic structures are actually an crucial portion of each company process in pharmaceutical and healthcare businesses. even if, while know-how is mixed with high-risk public defense initiatives or the creation and regulate of life-saving medicinal drugs or units, it is vital to make sure that it really is trustworthy, caliber guaranteed, and established. the main accomplished consultant on laptop validation presently on hand, containing greater than 2 hundred illustrations and greater than a hundred tables, desktops Validation is helping you notice the large picture.The writer studies rules and their improvement, association duties, validation existence cycle in accordance with GAMP4 consultant, strategic techniques to validation, digital documents and signatures, dealing with regulatory inspections, metrics, and possibilities for functionality development. He offers sensible examples and checklists through the publication and explores the function of caliber coverage and danger administration as key elements of pragmatic regulatory compliance. overlaying equipment that assist you stay away from duplicating attempt between departments and enterprise services, the e-book demonstrates how one can use your funding in know-how to enhance company potency and achieve the aggressive aspect.

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Additional info for Computer systems validation: quality assurance, risk management and regulatory compliance for pharmaceutical and healthcare companies

Example text

The additional cost generated by ensuring that the system is sound at every stage in its development, from conception to testing, is far less than the cost and effort of fixing the computer system afterward, not forgetting the hidden losses suffered through customer disaffection. So do not wait until the end of the project to put things right! ” This said, it is important to appreciate that planning does not come naturally to many people and the temptation to jump in to code development before the groundwork of properly defining requirements has been completed often proves irresistible.

Finally, Project Managers must not be too optimistic during the early stages of a project but bear in mind that most projects progress quickly until they are 90% complete. A strong Project Manager will need determination and commitment to drive the project to completion while maintaining quality and compliance. Keeping Current Validation practices must keep pace with the technical advances that are occurring constantly within industry. fm Page 9 Monday, November 10, 2003 10:23 AM Why Validate? , poor specification capture, design errors, and poor maintenance practice).

Food and Drug Administration [FDA] (2002), General Principles for Software Validation, Final Guidance for Industry, January. 2. M. (2000), On Time, Within Budget: Software Project Management Practices and Techniques, Third Edition, John Wiley & Sons, New York. 3. S. (1997), Validating Automated Manufacturing and Laboratory Applications: Putting Principles into Practice, Interpharm Press, Buffalo Grove, NY. 4. European Union (2002), Guide to Good Manufacturing Practice for EU Directive 2001/83/EC, Community Code Relating to Medicinal Products for Human Use, Volume 4.

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Computer systems validation: quality assurance, risk management and regulatory compliance for pharmaceutical and healthcare companies by Guy Wingate


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