Pharmaceutical Computer Systems Validation : Volume 2 - Real Life Case Studies
Language: English
Published by Taylor & Francis Ltd (Sales) Jun 2026, 2026
- Hardcover
- New
Seller: AHA-BUCH GmbH, Einbeck, GermanyAHA-BUCH GmbH
AbeBooks seller since August 14, 2006
Condition: New
£ 362.59
Quantity: 2 available
Add to basketItem description from seller
Neuware - Computerized systems play a fundamental role in the development, manufacture and supply of medical treatments. This is the third and thoroughly updated edition of the best-selling book dealing with validation, compliance and software in the pharmaceutical, healthcare and medical device industries. The first volume provides a comprehensive walk-through of lifecycle and development methodologies bringing together technological advances, latest regulatory requirements, inspection findings, and compliance strategies. New chapters have been added on agile development methodologies, data integrity, artificial intelligence and machine learning. The second volume comprises an extensive set of refreshed case studies spanning laboratory, manufacturing and supply chain systems with new contributions on databases, spreadsheets, LIMS, blockchain, mobile devices, AI-enabled systems, big data and digital twins authored by various industry experts.Key Features - Covers governance framework, roles and responsibilities, quality culture, project lifecycle, operational compliance, risk management, electronic records/signatures, supplier management, practical troubleshooting, handling regulatory inspections, metrics, and the opportunity for performance improvement - Provides a set of 22 new and updated case studies by industry experts, demonstrating how these computer system validation principles are put into practice - Focuses on GxP regulatory requirements covering GCPs, GLPs, GMPs, and GDPs-complete with observations from inspections by the US FDA and other regulators - Discusses industry regulations and guidance, including current thinking of the US FDA on computer software assurance, the latest guidance from the US FDA/EU/MHRA on data integrity, and the newly published ISPE GAMP 5 Guide (Second Edition) - Shares the practical experience and advice from a group of leading computer validation and compliance international experts. …
Seller Inventory # 9781041371151
- Title
- Pharmaceutical Computer Systems Validation : Volume 2 - Real Life Case Studies
- Author
- Guy Wingate
- Publisher
- Taylor & Francis Ltd (Sales) Jun 2026
- Publication year
- 2026
- Condition
- Neu
- Binding
- Buch
- Language
- English
- ISBN 10
- 1041371152
- ISBN 13
- 9781041371151
- Edition
- 3rd Edition
- Item weight
- 1,107 grams
- Dimensions
- 254x178x29 mm
Computerized systems play a fundamental role in the development, manufacture and supply of medical treatments. This is the third and thoroughly updated edition of the best-selling book dealing with validation, compliance and software in the pharmaceutical, healthcare and medical device industries. The first volume provides a comprehensive walk-through of lifecycle and development methodologies bringing together technological advances, latest regulatory requirements, inspection findings, and compliance strategies. New chapters have been added on agile development methodologies, data integrity, artificial intelligence and machine learning. The second volume comprises an extensive set of refreshed case studies spanning laboratory, manufacturing and supply chain systems with new contributions on databases, spreadsheets, LIMS, blockchain, mobile devices, AI-enabled systems, big data and digital twins authored by various industry experts.
Key Features
- Covers governance framework, roles and responsibilities, quality culture, project lifecycle, operational compliance, risk management, electronic records/signatures, supplier management, practical troubleshooting, handling regulatory inspections, metrics, and the opportunity for performance improvement
- Provides a set of 22 new and updated case studies by industry experts, demonstrating how these computer system validation principles are put into practice
- Focuses on GxP regulatory requirements covering GCPs, GLPs, GMPs, and GDPs―complete with observations from inspections by the US FDA and other regulators
- Discusses industry regulations and guidance, including current thinking of the US FDA on computer software assurance, the latest guidance from the US FDA/EU/MHRA on data integrity, and the newly published ISPE GAMP 5 Guide (Second Edition)
- Shares the practical experience and advice from a group of leading computer validation and compliance international experts
"Synopsis" may belong to another edition of this title.
About the Author
Guy Wingate, Ph.D., was Vice‑President of Compliance and before that Director of Global Computer Validation at GlaxoSmithKline until his recent retirement. A well‑known speaker on computer validation, he has over 30 years of experience in the pharmaceutical industry. He has been a visiting lecturer at the University of Manchester’s M.Sc. in Pharmaceutical Engineering Advanced Training program and the Dublin Institute of Technology’s accredited M.Sc. in Validation Science program. He is an active member of the ISPE and served as Chair of the GAMP® Council for 10 years, which is responsible for the internationally recognized suite of GAMP® Guides on computer compliance. Guy led the teams who produced the original GAMP®5 Guide: A Risk Based Approach to Compliant GxP Computerized Systems and the GAMP® Good Practice Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures. His extensive list of published work also includes the books Validating Automated Manufacturing and Laroratoty Applications, Validating Corporate Computer Systems and previous editions of this book, Pharmaceutical Computer Systems Validation.
"About the title" may belong to another edition of this title.
Shipping rates from Germany to U.S.A.
| Item | 7 to 10 business days | 5 to 7 business days |
|---|---|---|
| First item | £ 36.81 | £ 50.18 |
Payment methods
- Bank Wire Transfer
- Check
- Paypal
Store description
Das Unternehmen AHA-BUCH GmbH: Seit der Gründung von AHA-BUCH im Juli 2005 ist unser Hauptziel, zufriedenen Kunden so schnell und so preisgünstig wie möglich ihren Bücherwunsch zu erfüllen. Unsere Firma beschäftigt 16 Mitarbeiter, die nur ein Ziel kennen: den Kunden und seine Wünsche! Auf über 3700 m2 Fläche haben wir über 100.000 Bücher, Modernes Antiquariat und Spiele auf Lager.
Specialty
Kinderbücher & Kinderhör Casetten, German Books, Software, Natur & Tiere, Ratgeber, Sachbücher, Englische Bücher, Medizin & Gesundheit, Universität & StudiumSeller's business information
AHA-BUCH GmbH
Garlebsen 48
Einbeck, Germany 37574
Terms of sale
Imprint
Seller Info:
AHA-BUCH GmbH
represented by the managing director Christel Glass
Garlebsen 48
37574 Einbeck
Deutschland
Telefon: 055639996039
Telefax: 055639995974
E-Mail: abebooks@aha-buch.de
USt-IdNr.: DE261904229
registered at Commercial register Amtsgerichtes Göttingen
Handelsregisternummer HRB 200691
Alternative dispute resolution:
The European Commission provides a platform for out-of-court online dispute resolution (ODR platform), which can be accessed under https://ec.europa.eu/odr.
We have been a member of the "FairCommerce" initiative since 25.05.2018.
For more information, see www.fair-commerce.de.
Right of withdrawal
If you are a consumer you can withdraw from the contract in accordance with the following. Consumer means any natural person who is acting for purposes which are outside his trade, business, craft or profession.
Information regarding the right of withdrawal
Statutory right to withdraw
You have the right to withdraw from this contract within 14 days without giving any reason.
The withdrawal period will expire after 14 days from the day on which you acquire, or a third party other than the carrier and indicated by you acquires, physical possession of the last good or the last lot or piece.
To exercise the right of withdrawal, electronically fill in and submit a clear statement on our website, under "My Purchases" in "My Account". We will communicate to you an acknowledgement of receipt of such a withdrawal on a durable medium (e.g. by e-mail) without delay.
To meet the withdrawal deadline, it is sufficient for you to send your communication concerning your exercise of the right of withdrawal before the withdrawal period has expired.
Effects of withdrawal
If you withdraw from this contract, we will reimburse to you all payments received from you, including the costs of delivery (except for the supplementary costs arising if you chose a type of delivery other than the least expensive type of standard delivery offered by us).
We may make a deduction from the reimbursement for loss in value of any goods supplied, if the loss is the result of unnecessary handling by you.
We will make the reimbursement without undue delay, and not later than 14 days after the day on which we are informed about your decision to withdraw from this contract.
We will make the reimbursement using the same means of payment as you used for the initial transaction, unless you have expressly agreed otherwise; in any event, you will not incur any fees as a result of such reimbursement.
We may withhold reimbursement until we have received the goods back, or you have supplied evidence of having sent back the goods, whichever is the earliest.
You shall send back the goods or hand them over to AHA-BUCH GmbH, Einbeck, Germany, without undue delay and in any event not later than 14 days from the day on which you communicate your withdrawal from this contract to us. The deadline is met if you send back the goods before the period of 14 days has expired. You will have to bear the direct cost of returning the goods. You are only liable for any diminished value of the goods resulting from the handling other than what is necessary to establish the nature, characteristics and functioning of the goods.
Exceptions to the right of withdrawal
The right of withdrawal does not apply to:
- The delivery of newspapers, journals or magazines with the exception of subscription contracts; and
- The supply of digital content which is not supplied on a tangible medium (e.g. on a CD or DVD) if you accepted when you placed your order that we could start to deliver it, and that you could not withdraw once delivery had started.
Shipping terms
We ship your order after we received them
for articles on hand latest 24 hours,
for articles with overnight supply latest 48 hours.
In case we need to order an article from our supplier our dispatch time depends on the reception date of the articles, but the articles will be shipped on the same day.
Our goal is to send the ordered articles in the fastest, but also most efficient and secure way to our customers.