Open Hours of Qval Consulting Mon - Fri: 10.00 am - 6.00 pm.
Quality Management Services

Quality Management Services

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.

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Key Services

Implementation of 21 CFR Part 11 and EU Annex 11 Controls

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.

SOPs for Computerised Systems Validation

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.

Vendor Qualification and Assessments

We help evaluate and qualify vendors to ensure they meet the necessary quality standards and regulatory requirements, minimising supply chain risks.

Quality Management

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.

Audit Readiness and Support

We provide support to prepare for regulatory audits and inspections, including conducting mock audits, addressing audit findings, and implementing corrective and preventive actions (CAPAs).

Periodic Reviews

We conduct periodic reviews of quality systems and processes to assess their effectiveness, identify areas for improvement, and ensure ongoing compliance with regulatory requirements.

Change Management

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.

Key Services

  • Expertise: Our team comprises experienced professionals with in-depth knowledge of regulatory requirements and best practices in quality management.
  • Tailored Solutions: We customise our services to meet the unique needs and challenges of each client, ensuring practical and sustainable solutions.
  • Compliance Assurance: We are dedicated to helping our clients achieve and maintain compliance with regulatory standards, safeguarding product quality and patient safety.