At QVAL Consulting, we are committed to providing comprehensive Quality Management Services that ensure regulatory compliance and uphold the highest standards of quality within the pharmaceutical industry. With our extensive expertise and tailored solutions, we empower our clients to navigate complex regulatory landscapes and achieve excellence in quality management.
Our Approach:
Recognizing the critical importance of quality management in pharmaceutical operations, we adopt a proactive and systematic approach to address key aspects of quality assurance and compliance. Our methodology is designed to enhance operational efficiency, mitigate risks, and foster a culture of continuous improvement.
We assist in establishing and maintaining controls compliant with regulatory requirements, ensuring the integrity and security of electronic records and signatures. Qualification of Network and Infrastructure: Our team conducts thorough assessments and qualifications of networks and infrastructure to ensure they meet regulatory standards and support the reliable operation of computerised systems.
We develop comprehensive Standard Operating Procedures (SOPs) tailored to your organisation's specific needs, facilitating the validation of computerised systems in accordance with regulatory guidelines.
We help evaluate and qualify vendors to ensure they meet the necessary quality standards and regulatory requirements, minimising supply chain risks.
Our quality management solutions encompass the establishment of robust quality systems, including document control, training, and deviation management, to promote adherence to quality standards and regulatory compliance.
We provide support to prepare for regulatory audits and inspections, including conducting mock audits, addressing audit findings, and implementing corrective and preventive actions (CAPAs).
We conduct periodic reviews of quality systems and processes to assess their effectiveness, identify areas for improvement, and ensure ongoing compliance with regulatory requirements.
We assist in implementing change management processes to effectively manage changes to systems, processes, and documentation while maintaining compliance with regulatory standards, including adherence to GAMP 5 principles.