as its functionality during the sterilisation process. Regulatory bodies such as the FDA and EMA emphasize the utility of a risk-based approach in ICH Q9, which is instrumental in prioritizing validation efforts based on potential impact on product quality.

• Identify Critical Parameters: Determine the critical process parameters (CPP) and critical quality attributes (CQA) based on potential risks to product quality.
• Develop a Risk Management Plan: Establish a plan that outlines how to mitigate identified risks, ensuring devices operate within defined limits during sterilisation cycles.

Documentation requirements during this phase include a formal risk management report and the complete version of the URS. These documents must be maintained with version control to reflect any changes throughout the validation lifecycle.

Step 2: Protocol Design and Execution

After establishing the URS and conducting the risk assessment, the next step involves designing the validation protocol. This protocol serves as the blueprint for validation activities, outlining methodology for installations, performance qualifications, and operational validations.

The protocol must detail how the performance of the digital device will be validated, ensuring it meets all specified user requirements. This includes methods for testing the device’s data integrity, calibration, and operational limits. In accordance with FDA guidance, the protocol also needs to define acceptance criteria crucial for demonstrating the device’s capability in supporting sterilisation validation.

• Define Test Methods: Specify the methods that will be used to evaluate device performance alongside established SOPs.
• Identify Sampling Plans: Outline sampling strategies required for performance evaluation; this may involve extensive data collection during sterilisation cycles.

Regulatory guidelines, such as FDA’s Process Validation Guidance and EU’s Annex 15, specify that thorough documentation of protocol execution is essential. Each executed validation activity should be recorded comprehensively, including details like test dates, personnel involved, and any deviations from the planned activities, along with justifications for such deviations.

Step 3: Process Performance Qualification (PPQ)

The Process Performance Qualification (PPQ) stage plays a critical role in ensuring that the digital device maintains its integrity and efficacy during actual usage conditions. At this point, it is essential to collect data that demonstrates the device’s consistent performance across multiple sterilisation cycles.

During the PPQ phase, cooperative validation between the manufacturer of the digital device and the pharmaceutical company is crucial. This collaboration helps in verifying that the device operates effectively under practical conditions, supporting the sterilisation validation processes without compromising data accuracy.

• Real-World Simulation: Execute multiple sterilisation cycles, collecting performance data that aligns with the conditions expected in real operational use.
• Statistical Analysis: Apply statistical methodologies to assess the data collected. This ensures reproducibility and reliability; evaluate against pre-defined acceptance criteria set in the initial protocol.

Comprehensive data records must be kept during this phase, detailing every aspect of the PPQ activities including findings, deviations, and any corrective actions taken. Documentation must be maintained in accordance with Good Documentation Practices (GDP), which are fundamental in complying with Part 11 of 21 CFR, regarding electronic records.

Step 4: Continuous Process Verification (CPV)

Once the PPQ phase is successfully completed, the next step is to transition into Continuous Process Verification (CPV). This ongoing process involves real-time monitoring and documentation of the digital device’s performance throughout its operational lifecycle.

CPV aims to ensure that any variations in performance are monitored and addressed proactively, thereby maintaining compliance with regulatory standards over time. An effective CPV program must include robust methodologies for tracking data integrity while ensuring the device continues to meet user requirement specifications.

• Establish Key Performance Indicators (KPIs): Define KPIs to continuously assess the performance of the monitoring device against established benchmarks.
• Implement Real-Time Monitoring Systems: Utilize technologies that support instantaneous data collection and analysis, ensuring compliance with continuous validation practices.

Documenting the CPV activities is essential for regulatory compliance and should include regular reports that detail process performance, deviations identified, and corrective actions applied. This documentation must also reflect any changes made to the device post-qualification, ensuring a complete lifecycle history for audit purposes.

Step 5: Revalidation Strategies

Pharmaceutical processes and equipment must be subject to periodic revalidation to ensure that continued adherence to regulatory standards is maintained. In the context of sterilisation validation, this may be triggered by several factors including modifications to processes, changes in manufacturing conditions, or new regulations.

Developing a revalidation strategy involves assessing historical data from CPV activities to determine when revalidation is necessary. Risk assessments should be revisited, taking into account any changes that may impact the digital device’s performance and data integrity.

• Define Triggers for Revalidation: Create a comprehensive list of scenarios that mandate revalidation efforts, such as equipment changes, new product introductions, or procedural updates.
• Document the Revalidation Process: Maintain thorough records of all revalidation activities, ensuring compliance with documentation standards set forth in regulations such as Part 11 and GAMP 5.

Finally, ensure the revalidation plan outlines how results will be communicated to relevant stakeholders, including QA and regulatory affairs teams, maintaining transparency and fostering a culture of continuous improvement.