EU annex 11 guide to computer validation compliance for the Worldwide Health Agency GMP. (2015)

• Record Type: Book
• Further Information: Note: Orlando López.
• Authors: López, Orlando
• Contents: Introduction; References; ; SLC, Computer Validation, and Annex 11; Life-Cycle Principles; References; ; Annex 11 Principles; Analysis; Principle 1; Principle 2; Principle 3; References; ; Risk Management ; EU Annex 11-1, General; Related References; Analysis; Risk Assessment; Risk Mitigation; Risk Evaluation; Risk Monitoring and Control; Approach; Summary; References; ; Personnel ; EU Annex 11-2, General; Analysis; References; ; Suppliers and Service Providers; EU Annex 11-3, General; Analysis; Acquisition Process; Supply Process; References; ; Validation; EU Annex 11-4, Project Phase; Analysis; Computer Systems Validation; Primary Life-Cycle Processes; Acquisition Process; Supply Process; Development Process; Operation and Maintenance Processes; References; ; Data; R.D. McDowall; EU GMP Annex 11-5, Operational Phase; Introduction; Impact of Other Sections of Annex 11; Preserving the Content and Meaning of Data; Some Data Transfer Options; Manually Driven Electronic File Transfers; Copy and Paste/Drag and Drop Electronic Transfers; Ensuring Data Integrity; Automatic Methods of Electronic Data Transfer; Data Migration Issues; Validation Considerations for Data Transfer; Reference; ; Accuracy Checks; EU Annex 11-6, Operational Phase; Analysis; Accuracy Checks Performed by Computer Systems; Reference; ; Data Storage ; EU Annex 11-7—Operational; Analysis; Inputs and Outputs; Storage; Retention; References; ; Printouts; EU Annex 11-8, Operational Phase; Analysis; ; Audit Trails—Ensuring Data Integrity; R.D. McDowall; EU GMP Annex 11-9, Operational; Introduction; Relationship of Clause 9 to Other Sections in EU GMP; Chapter 4: Documentation Essentials; Security Section Clause 12.4; Annex 11 Audit Trail Requirements; Additional Audit Trail Requirements; Reference; ; Change and Configuration Management; EU Annex 11-10, Operational Phase; Other References; Analysis; Types of Maintenance; Data Migration; Retirement (If Applicable); References; ; Periodic Evaluation: Independent Review to Ensure Continued Validation of Computerized Systems; R.D. McDowall; EU Annex 11-11, Operational Phase Analysis; Overview of a Periodic Review; Objectives of a Periodic Review; Reviewer Skills and Training; How Critical Is Your System?; When to Perform a Review?; Types of Periodic Review; Writing the Periodic Review Plan; Preparation for a Periodic Review; Activities during the Periodic Review; Who Is Involved and What Do They Do?; Review of the Last System Validation; Reviewing Requirements: Role of Traceability; Other Areas for Review; Operational Review; IT Department Involvement; Reviewer’s Closed Meeting; Observations, Findings, and Recommendations; Closing Meeting; Documenting the Periodic Review; References; ; Security ; EU Annex 11-12, Operational Phase; Related References; Analysis; Physical Security; Network Security; Applications Security; Database Security/Integrity; References; ; Incident Management ; EU Annex 11-13, Operational Phase; Analysis; Process Equipment Related Malfunction; Software/Infrastructure Component Malfunction; Incorrect Documentation or Improper Operation; Emergency Incidents; References; ; Electronic Signatures: Electronic Signing Requirements ; R.D. McDowall; EU GMP Annex 11-14, Electronic Signatures; Introduction; Interpretation of Annex 11 Electronic Signature Regulations; Impact of Annex 11 Electronic Signature Requirements on Software Design; References; ; Batch Certification and Release ; Bernd Renger; EU Annex 11-15, Operational Phase; Related References; Introduction; Legal and Regulatory Background; The Qualified Person; Certification, Confirmation, and Certificates; IT Systems and QP Certification/Confirmation; The QP Relying on the Pharmaceutical Quality System; Control of Batch Release; ; Business Continuity ; EU Annex 11-16–Operational; Introduction; Analysis; Business Continuity Plan; Reference; ; Archiving ; EU Annex 11-17–Operational; Analysis; Method of Archival; Retirement; References; ; SLC Documentation ; Related References; Analysis; Summary; References; ; Relevant Procedural Controls ; Introduction; Reference; ; Maintaining the Validated State in Computer Systems ; Introduction; Operational Life; Operation Activities; Maintenance Activities; Summary; References; ; Annex 11 and the Cloud; R.D. McDowall and Yves Samson; Overview of the Chapter; EU GMP Annex 11; Legal Requirements; Data Privacy; Intellectual Property; Physical Location of the Server; Summary of GXP and Legal Requirements; What is Cloud Computing?; Customer Requirements for Cloud Computing; Cloud Service Models; Cloud Services Delivery Modes; Managing and Mitigating Regulatory Risk; SaaS Service Cloud Options; Single or Multi-Tenant Options; Requirements for Compliant IT Infrastructure; IT Infrastructure Elements; Service Providers: Requirements for Audits and Agreements; Auditing a Cloud Provider; Audit Objectives; What Are We Auditing Against?; Does ISO 27001 Certification Provide Compliance with GXP Regulations?; Methods of Auditing a Supplier; Questionnaire; Questionnaire plus Follow-Up; Questionnaire Plus On-Site Audit; How to Select an IT Service Provider; Stage 1: Review Provider Websites; Stage 2: Remote Assessment of the Quality Management System (QMS); Stage 3: On Site Audit of the Service Provider; What Do We Need in an Agreement?; Contract Management: How to Write a Contract; Operation and Monitoring Phase; References; ; EU GMP Chapter 4–Documentation and Annex 11 ; Markus Roemer ; Introduction; Overview EU GMP Chapter 4 Documentation; Documentation—Basic Setup and Requirements; Paper versus Electronic Records; What Is a Computerized System?; What Is Software?; What Is Data?; Timelines and Life Cycles; And Again Something about Audit Trails; Quality of Decisions; Data Rich—Information Poor (DRIP); GMP Datability; Validation and Data Integrity; ; Annex 11 and Electronic Records Integrity ; Introduction; Data Integ
• Edition: 1st
• Publisher Details: Boca Raton : CRC Press
• Publication Date: 2015
• Extent: 1 online resource, illustrations (black and white)
• Subjects: 338.476151; Pharmaceutical industry; Computer software -- Validation; Computer programs -- Validation; Medical informatics
• Languages: English
• ISBNs: 9781482243635
• Related ISBNs: 9781482243628
• Notes: Note: Description based on CIP data; item not viewed.
• 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.