Open Hours of Qval Consulting Mon - Fri: 10.00 am - 6.00 pm.
The role of infrastructure in managing applications and systems within the Life Sciences industry cannot be overstated, making infrastructure qualification a fundamental requirement for both regulators and customers. At QVAL Consulting, we understand the criticality of infrastructure qualification and have assembled a team with extensive experience in this domain to ensure compliance with regulatory standards.
Our Approach:
We approach infrastructure qualification with meticulous attention to detail, recognizing its significance in maintaining the integrity and reliability of systems within the Life Sciences sector. Our team leverages their in-depth expertise to develop robust qualification protocols tailored to the unique infrastructure requirements of each client. Through comprehensive assessments and rigorous testing, we verify the suitability and reliability of infrastructure components, ensuring compliance with regulatory guidelines and industry standards.
We collaborate closely with clients to develop comprehensive qualification plans, outlining the scope, objectives, and methodologies for infrastructure qualification activities.
Our team conducts thorough risk assessments to identify and prioritise critical infrastructure components, ensuring focused validation efforts on high-risk areas to mitigate potential compliance risks.
We assist in the development of qualification protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), tailored to the specific infrastructure requirements of each client.
We oversee the execution of qualification protocols and meticulously document all qualification activities and findings to provide a clear audit trail and ensure transparency throughout the qualification process.
Our team verifies the effectiveness of implemented controls and conducts comprehensive compliance verification activities to ensure that qualified infrastructure components meet regulatory requirements and industry standards.
