Auditee: Maintaining and validating computer systems used in our manufacturing and quality processes is essential to ensure data integrity, compliance with FDA regulations, and the accuracy of our operations. Here are a couple of examples of how we achieve this:
Example 1: Manufacturing Execution System (MES) Validation
- Planning Phase: Before implementing a new MES, we define the system requirements, including specifications, functionality, and security features.
- Vendor Evaluation: We evaluate potential MES vendors based on their track record, regulatory compliance, and system capabilities.
- Validation Protocol: A detailed validation protocol is developed, outlining the testing procedures, acceptance criteria, and roles and responsibilities of the validation team.
Acceptance Testing (UAT): The MES is tested extensively in a controlled environment to ensure it meets requirements and functions as intended.
Validation Report: A validation report is prepared, summarizing the testing results, any deviations encountered, and the overall conclusion of the validation process.
Ongoing Monitoring: The MES is subject to ongoing monitoring and periodic reviews to ensure it continues to operate in compliance with FDA regulations and our quality standards.
Example 2: Laboratory Information Management System (LIMS) Maintenance
- Change Control: Any changes to the LIMS, whether system upgrades, configuration changes, or new modules, undergo thorough change control procedures.
- Impact Assessment: Changes to the LIMS are assessed for their potential impact on data integrity, system functionality, and regulatory compliance.
- Validation of Changes: Depending on the nature of the change, validation activities such as acceptance testing (UAT) or regression testing are conducted to ensure the change does not adversely affect system performance.
- Documentation: Detailed documentation of changes, testing results, and validation activities is maintained to provide a clear audit trail and ensure data integrity.
- Periodic Review: The LIMS is subject to periodic reviews to identify opportunities for enhancements, updates, or improvements to ensure its continued compliance and effectiveness.
Through these examples and our systematic approach to computer system maintenance and validation, we uphold data integrity, regulatory compliance, and the accuracy of our manufacturing and quality processes in accordance with FDA requirements.