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

After the finalization of the Project Phase, we should update VMP for maintaining the system validated throughout the Operational Phase till retirement. We might follow the "Agile Approach" for implementation and hence there are many additional things or changes that we have been dealt with and VMP might lag the things/ activities which needs be included and the reason we should review and update it periodically for optimal utilisation which saves further efforts, cost and time many rise due to non compliances.

1. Regularly review VMP. 2. Implement change control. 3. Conduct periodic risk assessments. 4. Update training and documentation. 5. Stay informed about regulatory changes. 6. Follow a schedule for revalidation. 7. Communicate with vendors for updates. 8. Monitor and address audit trail anomalies.

1. Review and Reflect PQ Outcomes 2. Update System-Specific Information, if any changes were made during PQ that affect how the system is characterized. 3. Update the validation status to reflect that PQ has been completed and specify whether the system is now considered validated. 4. Update Training Requirements and Records 5. Modify SOPs and Quality Documents, Incorporate any changes to SOPs that were made during PQ or as a result of PQ findings. 6. Document Change Control Activities,Summarize any changes to the system or validation process that were documented through the change control system during PQ. 7. Obtain Approvals.

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

Computer system validation (CSV) is a process of ensuring that a computer system meets the specifications and requirements for its intended use. It involves planning, testing, documenting, and reviewing the system throughout its life cycle. One of the key documents in CSV is the validation master plan (VMP), which outlines the scope, strategy, roles, responsibilities, and deliverables for the validation project. But what happens after you complete the performance qualification (PQ), which is the final stage of testing the system under real-world conditions? How do you update and maintain the VMP to ensure ongoing compliance and quality? Here are some tips to help you with this task.

1 Review the VMP

After completing PQ, you should review the VMP to verify that all the validation activities and objectives have been met and documented. You should also check if there are any deviations, changes, or issues that need to be addressed or resolved. If there are any gaps or discrepancies, you should update the VMP accordingly and ensure that the relevant stakeholders are informed and involved.

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Anand Sharma 🇮🇳

Lead CSV- IT Validation and Quality Risk Management in Pharma/Life Science
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1. Regularly review VMP. 2. Implement change control. 3. Conduct periodic risk assessments. 4. Update training and documentation. 5. Stay informed about regulatory changes. 6. Follow a schedule for revalidation. 7. Communicate with vendors for updates. 8. Monitor and address audit trail anomalies.

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Vivek Vijayakumar

GxP & Life Sciences IT Compliance Leader | CSV / CSA | Cloud Validation | Regulatory Compliance | Audits & Inspections | RPA | AI IPower Apps
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1. Review and Reflect PQ Outcomes 2. Update System-Specific Information, if any changes were made during PQ that affect how the system is characterized. 3. Update the validation status to reflect that PQ has been completed and specify whether the system is now considered validated. 4. Update Training Requirements and Records 5. Modify SOPs and Quality Documents, Incorporate any changes to SOPs that were made during PQ or as a result of PQ findings. 6. Document Change Control Activities,Summarize any changes to the system or validation process that were documented through the change control system during PQ. 7. Obtain Approvals.

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Murthy Tmmurthy

Senior Manager - Quality Control| Expertise in CSV, QMS, Audits,OOS Investigations, | Enhancing Quality & Compliance in Regulated Environments | Driving Operational Excellence.
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Solid advice on maintaining the Validation Master Plan (VMP) post-CSV PQ completion. The steps outlined, from regular reviews and change control implementation to periodic risk assessments, training updates, and staying abreast of regulatory changes, provide a comprehensive strategy. The inclusion of revalidation scheduling, vendor communication for updates, and vigilance in monitoring audit trail anomalies reflects a proactive approach to ensuring the ongoing effectiveness of the validation process.

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2 Update the VMP

Updating the VMP after PQ may involve adding, deleting, or modifying sections or appendices to reflect the current status and results of the validation project. This could include the final version of the validation protocol and report, including test cases, test data, test results, and acceptance criteria. Additionally, you may need to update the VMP with a summary of any deviations, changes, or issues encountered during the validation process and how they were handled or resolved. Furthermore, evidence of approval and sign-off of the validation project by authorized personnel should be included in the VMP, as well as a list of deliverables and documents that have been completed and archived. Lastly, references to any standard operating procedures (SOPs) and guidelines that have been followed or developed for the validation project should also be included.

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Dipak N (GxP, CSV, ITQA Expert)☑️

Sr.Validation Lead|| M. Pharm, MBA|| 13+Years|| GXP, CSV-CSA Lead, ITQA- eCompliance || Data Integrity & Validation Expert || Risk Management, Project Management Professional || 30K+ Followers||
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After the finalization of the Project Phase, we should update VMP for maintaining the system validated throughout the Operational Phase till retirement. We might follow the "Agile Approach" for implementation and hence there are many additional things or changes that we have been dealt with and VMP might lag the things/ activities which needs be included and the reason we should review and update it periodically for optimal utilisation which saves further efforts, cost and time many rise due to non compliances.

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3 Maintain the VMP

Once PQ is completed, the validation project is not over. It is important to maintain the VMP throughout the life cycle of the computer system. This may involve reviewing the VMP periodically to evaluate its suitability and updating it when changes occur. Revalidation of the system or parts of it should be done based on risk assessment and change control procedures, while routine maintenance and monitoring should be done to verify performance and functionality. Additionally, auditing and inspecting the system and VMP is necessary for compliance and quality. The VMP is a living document that guides and documents the validation project, so by maintaining it after PQ you can ensure that your computer system remains validated and fit for purpose.

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4 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?

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M.V.Manikanta Kumar 🇮🇳

CSV Lead | Experienced Pharmaceutical and Consulting Professional | GxP Audits | Governance, Risk & Compliance (GRC) | IT Quality Assurance
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Agile methodologies emphasize continuous development and frequent releases, which can lead to frequent updates to the system after PQ. Each change may require a re-assessment of the validation status, and the VMP may need constant updating to reflect these changes.Adapt the VMP to fit the Agile framework by incorporating flexibility and allowing for incremental updates

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

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1 Review the VMP

2 Update the VMP

3 Maintain the VMP

4 Here’s what else to consider

Computer System Validation

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