Pharmaceutical and medical devices manufacturing computer systems validation / by Orlando Lopez
Material type:
TextBoca Raton : Taylor & Francis, 2018Description: xviii, 325 pages ; 26 cmContent type: - text
- unmediated
- volume
- 9781138041189
| Item type | Current library | Home library | Call number | Copy number | Status | Notes | Date due | Barcode | |
|---|---|---|---|---|---|---|---|---|---|
Book
|
MEDICAL LIBRARY Medical Library General Collection | MEDICAL LIBRARY Medical Library General Collection | RS122.2 . L66 2018 (Browse shelf(Opens below)) | 1 | Available | 003163-00-12 | 1000389383 |
Includes bibliographical references and index.
What is computer systems validation (CSV)? -- CGMP regulatory requirements for production computer systems -- Maxims in CSV -- General CSV principles -- System lifecycle (SLC) -- SLC documentation (cover the data integrity in documentation) -- Management of the computer system requirements -- Risk management based validation -- CSV plans and schedules -- Project management, SLC and production computers validation -- Computer systems operational life -- Suppliers and service providers -- Trustworthy computer systems -- Control of data and record -- Technologies supporting integrity of electronic records -- Infrastructure qualification overview -- Remediation projects -- Production CSV program organization -- Alignment between system and data lifecycle updated -- Digital date and time stamps -- New technologies and critical processes (access management; big data; clouds environments; IoT; SLAs, wireless) -- All together.