Computer System Validation
At Swiss Frameworks, we understand the critical importance of adhering to stringent regulations and standards in the validation of computer systems, especially within the life sciences sector.
Our Computer System Validation (CSV) services are designed to ensure that your IT systems meet the demands of regulatory compliance in GxP environments.
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We navigate the complex landscape of global regulatory requirements, including the European Union’s General Data Protection Regulation (GDPR) which mandates stringent data protection and privacy.
For our clients that target the US market, our validation processes are aligned with the principles set forth by the Food and Drug Administration (FDA), specifically under 21 CFR Part 11, which applies only to companies marketing their products in the U.S. This regulation governs electronic records and electronic signatures.
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Furthermore, our methodologies are grounded in the Good Automated Manufacturing Practice (GAMP 5) guidelines, the industry’s gold standard for validating automated systems, and reinforced by compliance with ISO 13485 and EudraLex Volume 4, Annex 11.
Our methodology is based on a risk-based management approach to reduce waste and to deliver value quick and compliant.
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Below we list the most relevant aspects of CSV activities and where we can support you.
Risk Assessment
Performing a risk assessment is identifying and evaluating risks associated with the computer system, functions and requirements to determine the focus of the validation efforts.
Swiss Frameworks facilitates thorough risk assessments to ensure prioritization of key system components, focusing validation efforts where they are most critical for compliance and operational success.
Traceability
Traceability Matrix Development: Creating a comprehensive traceability matrix that maps and links requirements through to the design specifications, testing, and final validation results. This ensures all requirements are accounted for and verified throughout the project lifecycle.
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Swiss Frameworks develops a detailed traceability matrix that serves as a cornerstone of our validation efforts, providing clear documentation that links requirements, specifications, tests, and results to ensure comprehensive coverage and compliance.
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Including traceability in the CSV process not only helps in maintaining systematic validation records but also facilitates efficient management of changes and simplifies compliance audits.
System Design Documentation
Translating requirements into detailed design specifications which guide development and configuration of the system.
Our team advises on the development of system design specifications that align with both client needs and regulatory standards, ensuring designs are both robust and compliant.
Change Management
dvising on the management of project and system changes.
We provide expert guidance on documenting, testing, and approving changes to maintain system integrity and compliance throughout the project lifecycle.
Documentation and Reporting
Finalizing and compiling comprehensive validation documentation.
Swiss Frameworks assists in the preparation of detailed Validation Reports that summarize the entire validation process, documenting the system's compliance with regulatory requirements and operational specifications.
This includes compiling results from risk assessments, design specifications, test management, and performance qualifications to provide a complete audit trail and support regulatory submissions.
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This comprehensive approach ensures that every aspect of the system validation is traceable, justified, and aligned with regulatory expectations, making it easier for clients to navigate audits and maintain compliance.
Validation Planning
Validation planning focuses on developing a validation plan that outlines the scope, approach, resources, and schedule of the validation activities.
We craft detailed validation plans that align with both regulatory requirements and your specific business needs, ensuring a clear and efficient validation process.
Requirements Specification
Defining detailed functional and non-functional requirements for the system.
Our team facilitates requirement gathering workshops and coaches individuals and team on how to record clear, concise and testable requirements to ensure the system is designed to meet both user needs and regulatory standards.
Test Management Strategy
Overseeing the strategy and execution of all testing phases.
Swiss Frameworks helps clients develop and manage a compliant testing strategy that includes unit, integration, system, and user acceptance tests to confirm system functionality and compliance.
Release Management
Preparing for system deployment with a focus on compliance.
Our consultants ensure that all aspects of system changes are validated and documented before release, facilitating a compliant and smooth transition to production.