and EMA’s Annex 15.

Validation Lifecycle: Understand the validation lifecycle as delineated by ICH Q8, Q9, and Q10.

Quality Systems Approach: Adopt a risk-based approach to validation in accordance with ICH Q9 to preemptively identify potential compliance issues.

Your organization’s quality assurance (QA) and quality control (QC) teams must ensure that they are up-to-date with any changes in regulations. Having an updated knowledge base will enhance the effectiveness of the VMP and its execution. Involvement in training workshops, webinars, and reading the latest industry journals can facilitate this understanding.

Step 2: User Requirement Specification (URS) and Risk Assessment

The next step is to develop a User Requirement Specification (URS), which outlines the essential functionalities and requirements that a computer system must satisfy to meet organizational and regulatory needs. The URS serves as a pivotal document as it plays a key role in guiding validation efforts.

When crafting the URS, it is essential to include:

• System Description: A clear overview of the system’s purpose and its expected role within the organization.
• Functional Requirements: Specific functionalities that the system should perform, including compliance with regulatory expectations.
• Performance Metrics: How the system’s performance will be tracked and measured.

Once the URS is developed, a thorough risk assessment should be conducted as part of a risk management strategy. Utilizing tools like FMEA (Failure Modes and Effects Analysis) can help quantify the risks associated with system failures and their potential impacts on product quality and patient safety.

By conducting these assessments, organizations can prioritize validation activities based on the determined risk levels. This aligns with regulatory expectations outlined in ICH Q9, facilitating a more comprehensive validation lifecycle.

Step 3: Protocol Design and Development

With a comprehensive URS and risk assessment in place, the next step involves the design and development of validation protocols. This foundational document details the specific procedures that will be followed throughout the validation process for computer system validation in pharma.

The protocol should include:

• Objective: Statement of purpose for the validation effort.
• Scope: Identification of which aspects of the system will be validated.
• Validation Strategy: Outline the approaches that will be used, including design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
• Acceptance Criteria: Clearly define what constitutes success or failure during the validation tests.
• Documentation Requirements: Specify the necessary documentation to be produced during the validation stages.

This protocol will serve as a roadmap for the validation activities and should be reviewed and approved by stakeholders, ensuring that all parties understand their roles and responsibilities throughout the process.

Step 4: Execution of Validation Activities

After the protocols are established and approved, the next critical phase is the execution of the validation activities. This step involves the actual testing and documentation of how the computer system meets its URS.

Throughout this phase, systematic approaches need to be adopted:

• Design Qualification (DQ): Confirm that the system design aligns with the URS and organizational needs.
• Installation Qualification (IQ): Validate the installation process and document that all components are properly installed and configured.
• Operational Qualification (OQ): Test the system’s functionality to ensure it operates as intended under expected conditions.
• Performance Qualification (PQ): Conduct tests under simulated operational conditions to demonstrate the system’s effectiveness in performing its designated tasks.

During these validation activities, detailed documentation must be collected to record all findings, test results, and potential deviations. This documentation will serve as a critical portion of the final validation report and ensure compliance with regulatory frameworks.

Step 5: Performance Qualification (PQ) and Protocol Review

Following the successful completion of OQ, the next step involves conducting the Performance Qualification (PQ). This stage aims to demonstrate that the system operates consistently and reliably in a simulated environment specific to end-user conditions.

Key elements of PQ include:

• Validation of User Scenarios: Creating test scenarios that reflect actual usage to confirm the system functions as required in real-world applications.
• Data Collection: Amass data that provides evidence of the system meeting the acceptance criteria set forth in your validation protocol.
• Final Overview: Document any observations or anomalies that may arise during PQ, including corrective actions or deviations, ensuring robust traceability throughout the process.

Once PQ is completed, perform a thorough logistical review of all collected data and ensure that documentation aligns with earlier phases. Any discrepancies should be resolved before proceeding with the next validation phase.

Step 6: Change Control and Continued Verification

Once the system is validated, it is crucial to implement a change control process. Change control outlines methods to evaluate, approve, and document adjustments to the validated system.

Components of effective change control include:

• Impact Assessment: Determine the potential impact of proposed changes on the system’s validated status and compliance with regulatory requirements.
• Documentation and Approval: Create a robust documentation trail supporting the change request and collect approvals from relevant stakeholders.
• Re-validation Activities: Identify situations that may necessitate re-validation, which may include significant modifications to the system, updates in software, or adjustments in regulatory requirements.

Continued verification may also be employed to maintain the system’s ongoing compliance. This can be done through audits, periodic reviews, and trend analysis to evaluate system performance over time.

Step 7: Revalidation and Lifecycle Management

The final phase in the validation process is revalidation. Revalidation should be performed periodically or whenever changes are made to the validated system or operational processes that may impact the system’s performance.

Key activities include:

• Establishing a Revalidation Plan: This plan should define when and how revalidation will occur, including criteria that warrant revalidation initiatives.
• Conducting Revalidation: Follow a simplified version of the initial validation process, concentrating on changes made since the last validation.
• Documenting Results: Capture metrics and document findings just as thoroughly as in the initial validation lifecycle.

Maintaining a living VMP requires ongoing commitment and responsiveness to change. An agile approach to validation enhances compliance, ensures regulatory alignment, and ultimately bolsters product integrity in the pharmaceutical industry.