Validating pharmaceutical systems: good
โ John Andrews
๐ Library
๐ English
โฆ LIBER โฆ
๐
Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation
โ Scribed by Orlando Lรณpez
- Publisher
- Productivity Press
- Year
- 2018
- Tongue
- English
- Leaves
- 344
- Category
- Library
โฌ Acquire This Volume
No coin nor oath required. For personal study only.
โฆ Synopsis
Validation of computer systems is the process that assures the formal assessment and report of quality and performance measures for all the life-cycle stages of software and system development, its implementation, qualification and acceptance, operation, modification, requalification, maintenance and retirement (PICS CSV PI 011-3). It is a process that demonstrates the compliance of computer systems functional and non-functional requirements, data integrity, regulated company procedures and safety requirements, industry standards, and applicable regulatory authority's requirements. Compliance is a state of being in adherence to application-related standards or conventions or regulations in laws and similar prescriptions.
This book, which is relevant to the pharmaceutical and medical devices regulated operations, provides practical information to assist in the computer validation to production systems, while highlighting and efficiently integrating worldwide regulation into the subject. A practical approach is presented to increase efficiency and to ensure that the validation of computer systems is correctly achieved.
๐ SIMILAR VOLUMES
Validating Pharmaceutical Systems: Good
โ John Andrews (ed.)
๐ Library
๐
2006
๐ CRC Press
๐ English
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 requirement
Validating Pharmaceutical Systems: Good
โ John Andrews (Editor)
๐ Library
๐
2005
๐ CRC Press
<p>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 requiremen
Validating Corporate Computer Systems: G
โ Guy Wingate
๐ Library
๐
2000
๐ Informa Healthcare
๐ English
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 I
Validation for Medical Device and Diagno
โ Carol V. Desain (Author); Charmaine V. Sutton (Author)
๐ Library
๐
1997
๐ CRC Press
<p>Implementation of FDA`s Design Control requirements (21 CFR 820.30) changed an entire industry. Quality System Requirements defined the approach to medical device validation. Product design, manufacturing process, and test method validation studies must be performed before or as a product is tran
Pharmaceutical and Medical Device Valida
โ Lynn D. Torbeck
๐ Library
๐
2007
๐ English