Open Hours of Qval Consulting Mon - Fri: 10.00 am - 6.00 pm.
Validation of computerised systems is a crucial aspect for organisations operating in the Life Sciences industry, extending beyond mere documentation. It is a time-intensive process that necessitates a deep understanding of the system's specific requirements. Our focus is on prioritising validation activities essential for regulatory compliance, ensuring adherence to applicable regulations.
Our Approach:
We recognize the complexity of computerised systems validation and adopt a systematic approach to ensure thorough compliance. By understanding the unique requirements of each system, we concentrate our efforts on validating functionalities critical for regulatory compliance. Our team collaborates closely with clients to streamline validation processes, minimising time and resource consumption while maintaining the integrity of validation outcomes.
We develop tailored validation strategies aligned with regulatory guidelines and industry best practices, ensuring comprehensive coverage of critical system functionalities.
Our approach emphasises risk-based validation, focusing validation efforts on high-risk functionalities to maximise efficiency and effectiveness.
We assist in the preparation of compliance documentation, including validation plans, protocols, and reports, ensuring thorough documentation of validation activities and outcomes.
Our team oversees the execution of validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), and verifies the effectiveness of implemented controls.
We provide ongoing support for compliance monitoring, conducting periodic reviews and assessments to ensure sustained compliance with evolving regulatory requirements.
