Computer System Validation Collaborative Articles

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.

Computer System Validation

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

14 contributions

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

Computer System Validation

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

31 contributions

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

Computer System Validation

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

18 contributions

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…

Computer System Validation

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

25 contributions

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

Computer System Validation

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

9 contributions

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.

Computer System Validation

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

18 contributions

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

Computer System Validation

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

18 contributions

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

Computer System Validation

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

10 contributions

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

Computer System Validation

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

17 contributions

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

Computer System Validation

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

11 contributions

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

Computer System Validation

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

59 contributions

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

Computer System Validation

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

1 contribution

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

Computer System Validation

How do you perform regression testing and revalidation for CSV?

13 contributions

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

Computer System Validation

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

3 contributions 4 months ago

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

Computer System Validation

How do you design a robust PQ protocol for CSV?

3 contributions

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.

Computer System Validation

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

5 contributions

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

Computer System Validation

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

6 contributions

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…

Computer System Validation

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

4 contributions

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

Computer System Validation

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

5 contributions

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

Computer System Validation

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

6 contributions

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

Computer System Validation

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

1 contribution

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

Computer System Validation

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

24 contributions

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

Computer System Validation

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

12 contributions

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

Computer System Validation

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

11 contributions

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

Computer System Validation

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

16 contributions

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

Computer System Validation

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

16 contributions

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…

Computer System Validation

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

1 contribution

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.

Computer System Validation

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

23 contributions

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

Computer System Validation

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

19 contributions

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

Computer System Validation

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

4 contributions

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

Computer System Validation

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

2 contributions

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…

Computer System Validation

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

11 contributions

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

Computer System Validation

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

23 contributions

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…

Computer System Validation

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

22 contributions

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

Computer System Validation

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

12 contributions

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

Computer System Validation

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

11 contributions

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

Computer System Validation

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

38 contributions

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…

Computer System Validation

What are the current trends in validation documentation and reporting?

25 contributions

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

Computer System Validation

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

7 contributions

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.

Computer System Validation

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

35 contributions 5 months ago

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

Computer System Validation

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

13 contributions

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

Computer System Validation

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

11 contributions

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…

Computer System Validation

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

60 contributions

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

Computer System Validation

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

17 contributions

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

Computer System Validation

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

22 contributions

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

Computer System Validation

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

43 contributions

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

Computer System Validation

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

3 contributions

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

Computer System Validation

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

12 contributions

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.

Computer System Validation

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

0 contributions

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

Computer System Validation

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

27 contributions

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

Computer System Validation

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

12 contributions

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

Computer System Validation

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

13 contributions

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…

Computer System Validation

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

9 contributions

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…

Computer System Validation

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

10 contributions

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

Computer System Validation

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

18 contributions

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

Computer System Validation