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

One effective strategy I have found for change control is implementing a rotational system for hosting the weekly change control meeting. By delegating this responsibility to different team members, it helps to involve everyone in the process and provides valuable insight into the challenges of maintaining a strong change control process. Not only does this approach foster a sense of ownership and accountability among team members, but it also allows the technical teams to gain a better understanding of the importance of maintaining a solid change control process.

1. Assess the change request 2. Assess the impact 3. Document the expected outcomes 4. Implement the change in a safe environment without impacting the existing setup 5. Test the changes and impacted functions 6. Implement the change in the live environment 7. Conduct Validation 8. Update documentation’s maintained 8. Train users

?? Mastering Change: Implementing Effective Control ?? ?? Clear Procedures: Precise guidelines for requesting, reviewing, and implementing changes. ?? Risk Assessment: Evaluate impacts before approving changes. ?? Security: Prevent unauthorized modifications and breaches. ?? Collaboration: Engage stakeholders for analysis and buy-in. ?? Tracking: Centralized system for accountability and auditing. ?? Continuous Improvement: Adapt and enhance efficiency. Embrace change responsibly! #ChangeManagement #ProcessImprovement

Validation Documentation: Computer System Validation documentation is only the objective evidence to prove the changes are validated. while documentation in SDLC process make sure, author must be follow the best practices to avoid data integrity issues in validation. Changes testing and Validation details must be updated in Validation plan, Test Plan as well. SDLC documents are plays an key role for validation of changes. Each documents should have specific document number format must be established and templates can be revise, if based on requirements. Key SDLC documents: 1. Change Control 2. VP 3. Specification (URS, FS, CRS, DS) 4. IQ, OQ, PQ 5. RTM 6. VR #csv #documentation #sdlc #validation

Changes control process is only the one to track all the changes in IT systems in SDLC methodologies i.e Agile. Every changes in systems should be assessed and do the impact analysis and identify the risk associated with the change, and identifies risk should be mitigated. Changes should be tested, documented, validated and deployed in prod. Frequency of change control review period established based system criticality and complexity and monitored change its entire life cycle of system. #addcomments #changecontrol #csv #lifesciences

If an entire system lifecycle approach is used for computer system validation, then there is no concept of revalidation. Prior to release to operations, the system is validated to ensure that it is fit for intended use. During the operational phase of the system lifecycle, enhancements and bug fixes are validated as part of operational change control. That involves an element of testing what has changed and regression testing what shouldn't have changed to give confidence that the change hasn't broken anything. The extent of testing should be based on risk. If the system is replaced with a new system or a major release that is like a new system, then a new lifecycle should be initiated and the system validated prior to release to operations

Risk based validation approach is the best approach for Effective validation as per GAMP 5 . Apply critical thinking on requirements, do the business process risk assessment leads produce risk based validation plan. Befits of Risk Based Validation approach: 1. Identification of risk levels from requirements 2. Identification of business process risk 3.Defined the Test strategies and Test types 4. Effective validation #addcomments #csv #validation

When determining the validation approach for system changes, it's crucial to conduct a risk assessment to understand the potential impact on product quality and regulatory compliance. This assessment guides the level of validation required, ensuring a proportionate response that neither overburdens resources nor compromises quality. It's also essential to consider the system's lifecycle stage, as changes in earlier phases might require a more rigorous validation than those in mature, stable systems. Always align the approach with industry best practices and current guidelines to maintain regulatory compliance.

The validation approach chosen should ensure that the system will be fit for purpose. Based on the system, category, nature of change, impact of change to the current validated stage of system and applicable regulatory requirements, scope the applicable approach should be used. Also critical thinking concepts and risk based approach should be factored while the team determines the applicable strategy.

Based on my experience in CSV, there is no activity such as revalidation. Below are the major factors that decide the validation approach for a GxP system: Lifecycle Phase: During initial implementation, a comprehensive validation effort may be needed. Subsequent phases, such as routine use or upgrades, may require less extensive validation. System Criticality: Systems that directly impact patient safety, product quality, or data integrity require more rigorous validation. System Complexity: This includes integrations and interdependencies. Vendor Competency, Reputation, and Track Record: Type of Change and Its Risk and Impact: The Functionality or Change Is OOB, Configuration, or Customization Required:

I find this article to be confusing and not very helpful. For example "The validation documentation should ensure that the change is clearly described and justified in the validation plan". The Validation Plan is one of the deliverables that are typically generated during computer system validation and is therefore part of the validation documentation. It would be more accurate to say the Validation Plan should describe how changes and updates to the validated system will be managed. Alternatively that could be governed by the procedure for Change Control. For example, the Change Request/Change Plan for an update to a validated system will specify what validation documentation needs to be updated. This will depend on what the change is.

Effective validation documentation acts as a living record, ensuring that any changes to a system do not compromise its integrity. It's crucial to maintain a 'validation continuum' where the system's validated state is preserved through meticulous documentation of changes. This process not only demonstrates compliance with regulatory requirements but also provides a clear roadmap for future system updates, facilitating easier and more efficient revalidation efforts when necessary.

It is important to determine the update/create validation documentation based on type/nature of change. Hence performing an impact analysis for validation documentation would be a critical activity. Based on this the applicable documentation can be created/upversioned. For minor changes, the entire set of documentation’s might not be required as compared to a major change ( eg. new system implementation) which would need the whole set of lifecycle system documentation to be created. CSA ideologies needs to be applied for documentation aspect.

The only time the validation protocol is updated, is after the execution if you find discrepancies that impact the correctness of the protocol. These protocols can then be used in the future for revalidation process in case the equipment/system has to move.

Up-to-date validation documentation is crucial for ensuring the integrity of the system throughout its lifecycle. Changes must be managed meticulously, with a clear rationale for each modification and a robust testing strategy to confirm that the system continues to meet predefined specifications. This process not only supports regulatory compliance but also fortifies the system against potential risks associated with changes, thereby safeguarding product quality and patient safety. If a change, i.e., a new release, causes a catastrophic system failure, a firm needs to revert not only to a prior release but also the documentation that goes with the release. Inspection readiness has to be constantly maintained.

Several ongoing activities and practices are essential to maintain a computer system's validation status. 1. Periodic Review 2. Change Management 3. Revalidation 4. System Monitoring 5. Documentation Updates 6. Training and Competency 7. System Maintenance 8. Regulatory Compliance 9. Issue Management Actively managing these activities can help ensure your system remains validated, compliant, and effective throughout its lifecycle.

A prevalent myth in CSV is treating Validation as a "one-time event," but that's not the case. In my experience and industry practice, we uphold a "Validated state" across a system's entire lifecycle. This necessitates updated procedures, training, and routine reviews to ensure ongoing compliance, suitability, and alignment with organizational guidelines. As the operational phase can span years with evolving services, software, hardware, processes, and regulatory demands, periodic system reviews are a vital strategy. These reviews affirm continued compliance, fitness for purpose, and alignment with organizational protocols. With time, we use these reviews to identify opportunities for enhancing processes and systems.

Perform regular periodic reviews based on the criticality of systems to ensure they are in validated state. Ensure you have recorded gaps in validation areas such as backup and restore configurations, change management processes, trainings, business continuity planning, change impact assessments, product release motes if COTs product, user access management etc. Ensure all Deviations are formally recorded in RAID LOG system and CAPAs are tracked, acted upon, closed as per plan

The use of SaaS products makes it even more critical to see validation as continuous activity than a one time event. With SaaS applications, the end client is not in full control of the changes making it into the system, and classic “change control” processes are not enough to maintain validated state. This can become especially problematic when custom interfaces or modules are also involved. Other mechanisms must be deployed to ensure SaaS systems remain fit for intended use.

Maintaining the validation status of a computer system is critical to ensure ongoing compliance with regulatory requirements. I can attest to the importance of regular audits and security measures to prevent data integrity issues. It's essential to have a robust change control process in place to manage updates and ensure that validation documentation is kept current. This proactive approach to validation maintenance is key to avoiding costly regulatory non-compliance and ensuring the reliability of the system.

First of all , do not go for the one size fit prescription. This is true for validation and change controls too. Based on the risk appetite of the regulated company, first define cases when you require vs not require a change control. This can be huge savings in efforts and refocus on greater priority actions.

Just don't forget the "Risk and Impact Assessment" section of the change control process... And you will be able to conclude all necessary things to do or things that are not Required to do.... Think on: Risk? Impact? Impacted functions and Stakeholder, approvals? Regression required? Documentation change/ update? Approvals? And Go.....

The changes to a validated system must be governed via change control process during the routine use of the system. Any change to a validated status of a system must be traceable.

Performance Qualification (PQ) is a critical component of CSV, ensuring that a system performs as intended in the actual working environment. It's important to conduct PQ after Installation Qualification (IQ) and Operational Qualification (OQ) are completed. PQ should involve testing with real-life data and scenarios to validate that the system can handle its intended tasks under normal and peak load conditions. This phase is essential for verifying that the system will function correctly and consistently in its operational phase, providing confidence in its reliability and compliance with regulatory standards.

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