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ROI CalculatorQMS software process validation is a documented, systematic process that demonstrates that a QMS software consistently performs as intended and meets predefined requirements.
The main goal of QMS software process validation is to confirm that the system is suitable, consistent, and reliable. In regulated industries, such as life sciences, process validation supports compliance with applicable regulatory requirements and industry standards.
QMS process validation ensures that a QMS performs as designed and meets predetermined user and regulatory requirements. The importance of QMS process validation is scientific and is relevant to data integrity, product quality and patient safety in highly regulated industries.
The QMS software process validation involves a lifecycle-based eleven-step process designed to confirm the reliability and compliance of the system.
Risk Assessment: Risk assessment will identify and evaluate software risks to determine the scope and depth of validation.
Validation Planning: Validation planning will detail the validation strategy, objectives, scope, roles, deliverables, and acceptance criteria. A traceability matrix is used to link each requirement to the test cases to ensure coverage.
User Requirement Specifications (URS): In URS, operational and regulatory requirements are established and documented for the software to support its use.
Functional and Design Specifications Review: Functional and design specifications translate the URS into technical design and ensure alignment with user needs.
Installation Qualification (IQ): Installation Qualification establishes that the software and the infrastructure have been installed properly.
Operational Qualification (OQ): Operational Qualification establishes that all functional requirements of the software operate in a controlled test environment.
Performance Qualification (PQ): Performance qualification establishes that the software operates reliably under the operational environment.
Validation Reporting and Release for Use: The Validation Report documents a summary of the validation activities and authorization to release for use that the system is functional and approved for use.
Change Management: It includes all changes or updates made to software and how they are managed, assessed, tested and documented to maintain the validated state of the software.
Periodic Review: The periodic system review verifies that it continues to be validated and compliant.
Software Retirement: Software retirement procedures ensure that data remains valid and accessible when software is taken out of service.
Quality Management System process validation requirements come from multiple sources including standards, guidelines, and regulations. Major sources of requirements will include: 21 CFR Part 11 by the FDA governing electronic records and signatures, EU GMP Annex 11 on computerized systems in a Good Manufacturing Practice environment, ISO 13485:2016 governing quality management systems for medical devices, GAMP 5 providing a risk-based framework for validation.
To maintain an ongoing state of compliance for a validated electronic quality management system, qualified organizations will develop comprehensive change control procedures, perform scheduled periodic reviews, undertake revalidation of the software following significant changes to the software, maintain secure system administration procedures, and follow SOPs relating to operation, security, and data management.
The most significant benefits of QMS software process validation are increased regulatory compliance and audit readiness, improved performance of the system, and improved data integrity and operational efficiency.
