Pharmaceutical and medical devices manufacturing computer systems validation. (2018)

• Record Type: Book
• Further Information: Note: By Orlando Lopez.
• Authors: López, Orlando
• Contents: 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.
• Publisher Details: Place of publication not identified : Productivity Press
• Publication Date: 2018
• Extent: 1 online resource (326 pages)
• Subjects: 615.10285; Equipment and Supplies; Computer Systems; Computer Security; Technology, Pharmaceutical -- methods
• Languages: English
• ISBNs: 9781351704342; 1351704346
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.