SAP CSV & GxP in LSHC

What is the primary goal of Computer System Validation (CSV) in SAP projects?

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Explain the relationship between CSV and GxP.

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What is the 'V-Model' in the context of SAP CSV?

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What does GAMP 5 stand for, and why is it important?

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How does CSV impact the SAP Blueprinting phase?

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What are the common pitfalls in SAP CSV projects?

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What is an Installation Qualification (IQ)?

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What is an Operational Qualification (OQ)?

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What is a Performance Qualification (PQ)?

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Why is 'Electronic Signature' (21 CFR Part 11) critical in SAP CSV?

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What is the purpose of a Traceability Matrix (TM)?

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How does 'Data Integrity' apply to SAP CSV?

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What is a 'Validation Summary Report' (VSR)?

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What is the 'intended use' principle?

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How does Change Management intersect with CSV?

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What is Category 4 vs Category 5 in GAMP 5?

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What is a Functional Risk Assessment (FRA)?

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Who is responsible for the final 'release' of a validated system?

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What are peripheral systems in SAP CSV?

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Define 'Legacy System Migration' in CSV.

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What is 'Retrospective Validation'?

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What is a Validation Plan (VP)?

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What is a 'Critical Process Parameter' (CPP)?

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What is 'Vendor Audit' in the context of CSV?

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What is 'Audit Trail Review'?

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What is MLPS 2.0 and its relevance to SAP in China?

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How does PIPL affect SAP user data?

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What is the 'Golden Tax' integration requirement?

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What is the NMPA's stance on SAP CSV?

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What is 'Data Localization' for SAP China?

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Define 'Cross-Border Data Transfer' (CBDT) in SAP.

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What is the CAC?

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How does the 'Data Security Law' (DSL) impact SAP projects?

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What is 'MLPS Filing'?

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What is an 'Appointed Third-Party' audit in China CSV?

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Does SAP China require a 'GB' (Guobiao) standard check?

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How are 'Fapiao' audits conducted in a validated SAP environment?

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What is 'Sensitive Personal Information' under PIPL?

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What is 'De-identification' in SAP China reporting?

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What is the 'Cryptographic Law' of China?

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What is a 'Data Protection Impact Assessment' (DPIA)?

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How does 'NMPA Annex 1' apply to SAP?

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What is the 'Cybersecurity Review' for SAP PCE in China?

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What is 'Localization Validation'?

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What is 'Joint and Several Liability' in PIPL?

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What is 'Self-Assessment' for data export?

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How is 'Audit Trail' compliance checked by NMPA?

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What is 'Network Security Domain' in MLPS?

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What is the 'Designated Data Handler'?

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What is 'Standard Contractual Clauses' (SCC) in China?

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How does CSV change for S/4HANA PCE compared to On-Premise?

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What is the impact of SAP's 2-year release cycle on PCE validation?

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What is the 'Shared Responsibility Model' in PCE CSV?

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How does 'Automated Regression Testing' support PCE CSV?

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What is a 'Validation Platform' in the PCE model?

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What is the customer's role in PCE Infrastructure Qualification?

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Does PCE allow for ABAP customization in CSV projects?

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How are SAP PCE 'Managed Services' validated?

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What is 'Cloud Compliance' documentation for PCE?

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What is the risk of 'Force-Upgrades' in PCE?

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How does BTP (Business Technology Platform) impact PCE validation?

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What is 'Configuration as Code' in cloud CSV?

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Why is 'Identity Management' (IAM) more critical in PCE?

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What is the role of the 'Qualified Infrastructure' in PCE?

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Does SAP PCE use the V-Model?

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What is 'OQ by SAP'?

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How does 'Sandbox' environment use differ in PCE CSV?

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What is a 'Validation Assessment' for PCE notes?

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What is the 'One-System' fallacy in cloud?

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What is 'Electronic Document Management' (EDMS) for PCE?

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How are cloud 'Integrations' (e.g., via APIs) validated?

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What is 'SaaS validation' vs 'PCE validation'?

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What is 'Release Management' in a validated PCE setup?

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What is 'Tenant Separation' in PCE CSV?

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What is 'User Acceptance Testing' (UAT) in PCE?

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Which SAP modules typically fall under GMP (Manufacturing)?

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Which SAP modules are primarily governed by GDP (Distribution)?

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How does GLP (Laboratory) manifest in SAP?

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What is the regulatory status of EU Annex 11 vs FDA Part 11?

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What is a GAMP Category 3 system?

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What is the focus of 'Interface Validation'?

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How does Cloud ALM centralize validation deliverables?

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Define the 'Federated Validation' pattern.

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Name two leading 'Paperless Validation' platforms.

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What tool identifies affected GxP objects during a patch?

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Define the 'Bluefield' migration path.

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What is the 'Clean Core' benefit for CSV?

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What does 'Enduring' mean in ALCOA+?

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What is the NMPA Annex scope for computerized systems?

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What is the 'GTI' validation requirement?

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What is required for MLPS Level 3 certification?

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How does expert expertise apply in CSA 'Unscripted Testing'?

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What are 'Delta Requirements'?

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What does the PCE 'QRS' grant the customer?

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What is 'Continuous Validation'?

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Why is 'Traceability' the heart of CSV?

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What is the role of the 'Process Owner'?

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How does China's DSL classify data?

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What is 'Data Residency' under PIPL?

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What is the 'V-Model'?

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