计算机系统验证协作文章 - 56 篇文章

How do you plan and execute computer system validation projects within budget and timeline?

Learn how to plan and execute computer system validation projects within budget and timeline using a systematic and risk-based approach.

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How do you manage the roles and responsibilities of the OQ team and stakeholders?

14 次贡献 5 个月前

Learn how to define, communicate, and review the roles and responsibilities of the OQ team and stakeholders in computer system validation.

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What are the benefits and drawbacks of using automated tools for CSV vs verification?

31 次贡献

Learn how automated tools can facilitate or complicate computer system validation (CSV) and verification in regulated industries.

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How do you follow up and close out a CSV audit?

18 次贡献

Learn how to follow up and close out a computer system validation (CSV) audit in five steps: audit report, corrective action plan, execution, closure request, and…

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How do you define the scope and boundaries of software validation for FDA-regulated systems?

25 次贡献 5 个月前

Learn how to define and document the scope and boundaries of software validation for FDA-regulated systems, following the FDA guidance on software validation.

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What are the common challenges and risks of conducting PQ and UAT in parallel or sequentially?

9 次贡献

Learn about the pros and cons of conducting PQ and UAT in parallel or sequentially for computer system validation, and get some tips for successful testing.

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How do you apply the principles of data integrity and security to your PQ data and records?

18 次贡献 5 个月前

Learn how to apply the principles of data integrity and security to your Performance Qualification data and records in Computer System Validation.

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What are the essential skills and tools for user requirements elicitation and analysis for CSV?

18 次贡献 4 个月前

Learn what are the essential skills and tools for user requirements elicitation and analysis for computer system validation (CSV), and how to apply them.

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What are the latest trends and innovations in IQ and verification methods and technologies?

10 次贡献 4 个月前

Learn about the latest methods and technologies for installation qualification (IQ) and verification in computer system validation (CSV), such as risk-based…

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How do you document and report the results and issues of user acceptance testing for CSV?

17 次贡献

Learn how to document and report the UAT results and issues for CSV, and create a UAT documentation package that validates your system.

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How do you manage changes and revisions to user requirements specification?

11 次贡献

Learn best practices for managing changes and revisions to user requirements specification (URS) for computer system validation (CSV) based on ISO standards.

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How do you prioritize the risks of your computer system validation (CSV) projects?

59 次贡献

Learn how to apply a risk-based validation strategy to your computer system validation projects, and optimize your validation efforts.

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How do you ensure data integrity and security throughout the equipment lifecycle?

1 次贡献

Learn how to ensure data integrity and security for equipment used in regulated industries throughout the equipment lifecycle, from design to decommissioning.

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How do you perform regression testing and revalidation for CSV?

13 次贡献

Learn what regression testing and revalidation are, why they are important for computer system validation (CSV), and how to perform them effectively.

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How do you monitor and improve the performance of computer systems after performance qualification?

3 次贡献 2 个月前

Learn six best practices for monitoring and improving your computer systems after performance qualification (PQ), the final phase of computer system validation…

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How do you design a robust PQ protocol for CSV?

3 次贡献

Learn how to design a robust PQ protocol for CSV to verify your system's performance and compliance. Follow these six steps to plan, execute, and document your PQ.

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What are the tools and techniques that can help you perform a periodic review faster and easier?

5 次贡献 5 个月前

Learn some tools and techniques that can help you streamline your periodic review process and optimize your resources in computer system validation.

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How do you document and report performance issues or deviations in cloud systems during PQ?

6 次贡献

Learn how to document and report performance issues or deviations in cloud systems during PQ, the final step of CSV. Understand the cloud service model, define…

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How do you define the scope and objectives of ORT for a software system?

4 次贡献

Learn how to define the scope and objectives of operational readiness testing (ORT) for a software system in computer system validation (CSV).

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How do you update and maintain the validation master plan (VMP) after completing PQ for CSV?

5 次贡献

Learn how to review, update, and maintain your validation master plan (VMP) after completing performance qualification (PQ) for computer system validation (CSV).

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How do you align your periodic review strategy with your business objectives and needs?

6 次贡献

Learn how to plan and execute periodic review of computer systems for CSV and ensure compliance, performance, and reliability.

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How do you leverage automation and data analytics for performance qualification?

1 次贡献

Learn how to leverage automation and data analytics for performance qualification (PQ) in computer system validation (CSV) to save time, money, and resources.

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How do you validate cloud-based systems and applications in a gxp environment?

24 次贡献

Learn how to validate cloud-based systems and applications in a regulated industry that follows good practices (GxP) standards. Discover the main challenges and…

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How do you define the scope and objectives of user acceptance testing for CSV?

12 次贡献

Learn how to define the scope and objectives of user acceptance testing (UAT) for computer system validation (CSV) in this article.

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What are the common challenges and risks in performing OQ in pharma?

11 次贡献

Learn about the common challenges and risks in performing operational qualification (OQ) in pharma computer system validation (CSV) and how to overcome them.

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How do you define the scope and purpose of CSV vs verification?

16 次贡献

Learn the basics of computer system validation (CSV) and verification, how they differ, why they are important, and how to apply them effectively.

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How do you conduct performance qualification testing and review for a cloud-based computer system?

16 次贡献

Learn how to conduct performance qualification testing and review for a cloud-based computer system, and what tools and tips you can use to make your process easier…

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How do you handle OQ failures and corrective actions in pharma?

1 次贡献

Learn best practices and tips for dealing with OQ failures and corrective actions in CSV for pharma. Find out how to fix and re-test the system in a compliant way.

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How do you verify and validate the data integrity and security of a GAMP 5 software system during PQ?

23 次贡献

Learn what PQ is, how to prepare for it, and what to document and report for GAMP 5 software systems validation.

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How do you handle deviations and non-conformities in your VSR GAMP 5 process?

19 次贡献

Learn how to use risk-based validation, deviation management, and validation summary report to handle deviations and non-conformities in your computer system…

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How do you use automation tools and frameworks for CSV functional testing?

4 次贡献

Learn how to use automation tools and frameworks to streamline and optimize your CSV functional testing process, and what benefits and challenges they offer.

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How do you balance ORT time and resources with other project constraints and expectations?

2 次贡献

Learn how to balance ORT time and resources with other project factors for your CSV projects. Discover tips and best practices to optimize your ORT process and…

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How do you conduct the periodic reviews and revalidation of the system after the PQ?

11 次贡献

Learn how to conduct periodic reviews and revalidation of your computerized system after the PQ to maintain its validated state and compliance.

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How do you handle changes and deviations during and after the validation process?

23 次贡献

Learn how to handle changes and deviations during and after the computer system validation process, and what best practices to follow to maintain the validated…

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What are the best tools for testing and verifying your computer system validation outcomes?

22 次贡献

Learn about the best tools and techniques for testing and verifying your computer system validation outcomes in regulated industries.

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How do you monitor and maintain the performance of your software system after PQ is completed?

12 次贡献

Learn how to monitor and maintain the performance of your software system after completing Performance Qualification (PQ) using periodic reviews, change control…

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What are the essential components of a validation summary report (VSR) for CSV?

11 次贡献

Learn what a validation summary report (VSR) is and what are its six essential components for computer system validation (CSV).

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What are common myths about computer system validation and how do you debunk them?

38 次贡献

Learn what computer system validation (CSV) really is and why it matters for quality, compliance, and efficiency. Discover how to debunk six common myths and…

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What are the current trends in validation documentation and reporting?

25 次贡献

Learn about the current trends and innovations in validation documentation and reporting that can help you streamline, simplify, and standardize the process.

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How do you review and audit your change control process and documentation for your CSV system?

7 次贡献

Learn how to review and audit your change control process and documentation for your computer system validation (CSV) system with these best practices and tips.

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What are the current trends and innovations in computer system validation methodologies and tools?

35 次贡献 4 个月前

Learn about the current trends and innovations in computer system validation methodologies and tools, such as risk-based approach, agile methodology, automation…

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How do you maintain and improve the performance of a computerized system over its lifecycle?

13 次贡献

Learn how to maintain and improve your computerized system performance over its lifecycle with these six best practices and guidelines for CSV.

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How do you document and report the results and deviations of validation for AI and ML systems?

11 次贡献

Learn the six steps to document and report the results and deviations of validation for AI and ML systems, following the best practices of computer system…

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How do you manage changes and updates to the validated system?

60 次贡献 5 个月前

Learn how to manage changes and updates to software systems that need to be validated for regulated industries, based on the software development lifecycle.

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How do you monitor and maintain the performance and quality of AI/ML systems after deployment?

17 次贡献

Learn how to monitor and maintain the performance and quality of AI/ML systems after deployment using best practices and tools for validation.

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How do you conduct and report the validation testing activities and results?

22 次贡献

Learn the four main steps of validation testing for computer system validation: planning, executing, evaluating, and reporting. Find out some best practices and…

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How do you manage the validation lifecycle of a computer system from inception to retirement?

43 次贡献 4 个月前

Learn how to manage the validation lifecycle of computer systems in regulated industries, from planning to retirement. Discover the phases, documents, and best…

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How do you balance speed and rigor in performance qualification in agile?

3 次贡献

Learn how to balance speed and rigor in performance qualification (PQ) in agile computer system validation (CSV) with these tips.

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How do you design and execute PQ protocols for computer systems that use cloud services or AI?

12 次贡献

Learn how to design and execute PQ protocols for computer systems that use cloud services or AI, following the CSV standards for data integrity and security.

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How do you evaluate the performance and suitability of OQ tools and methods?

0 次贡献

Learn how to evaluate the performance and suitability of operational qualification (OQ) tools and methods for computer system validation (CSV) in pharma.

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How do you define and validate user requirements and functional specifications in GAMP 5?

27 次贡献 4 个月前

Learn how GAMP 5 changed the way of defining and validating user requirements and functional specifications for computer system validation.

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How do you review and approve the PQ documentation and deliverables for a GAMP 5 software system?

12 次贡献

Learn the best practices and tips for reviewing and approving the Performance Qualification documentation and deliverables for GAMP 5 software systems in CSV.

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How do you define the scope and purpose of a software validation project?

13 次贡献

Learn how to define the scope and purpose of a software validation project for regulated industries. Follow these six steps to ensure quality, reliability, and…

计算机系统验证

How do you document and manage the approval and sign-off process of your URS for CSV?

9 次贡献

Learn how to use a User Requirements Specification (URS) template to document and manage the approval and sign-off process of your URS for Computer System…

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How do you update and maintain the VSR throughout the system lifecycle and change management?

10 次贡献

Learn how to update and maintain validation summary report (VSR) in computer system validation (CSV) following FDA guidelines and best practices.

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How do you select and evaluate software validation tools and methods?

18 次贡献

Learn how to choose and assess the best tools and methods for validating your computer systems according to standards and guidelines.

计算机系统验证