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PK stat analysis and regulatory support

QMS Set up Old

Zenovel: Driving Quality, Ensuring Your Success
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welcome to zenovel

A quality management system (QMS) is a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. It helps organizations coordinate activities, meet customer and regulatory requirements, and improve efficiency. It is the most prominent approach to QMS, but the term “QMS” refers to the entire system, not just the standard or related documents.
Zenovel supports the setup and continuous improvement of QMS of CRO/Site/Pharmaceutical company, ensuring your organization meet customer and regulatory requirements, and enhance operational efficiency.

Benefits of QMS with Zenovel

Implementing a quality management system with Zenovel’s support significantly impacts your organization’s performance and improves quality of your system without delaying any procedure.
  • Stating, Strengthening, Managing procedures
  • Minimizing waste
  • Eliminating errors
  • Narrowing expenses
  • Facilitating and acknowledging training possibilities
  • Motivating employees
  • Articulating the organization's overall vision
  • Conveying intent to provide consistent outcomes.
Having QMS ensures compliance with regulations and provides cost-efficient products and services, allowing for expansion, growth, and profit.

Zenovel’s Elements of QMS setup

Zenovel’s approach to QMS setup includes several key components with a comprehensive approach that aims to meet the needs of an organization and its clients’ specific requirements.
  • The company objectives and policies for quality
  • Quality manual
  • Data management
  • Internal process
  • Client satisfaction with product quality
  • Quality evaluation
  • Procedures, guidelines and recommendation

ESTABLISHING AND IMPLEMENTING A QMS

We deploy the plan-do-check-act (PDCA) cycle to design and implement a QMS, facilitating continuous improvement in system.

Step 1

  • Design and build : The and build stages of a Quality Management System (QMS) involve creating its structure, processes, and implementation plans, with senior management overseeing this process.

Step 2

  • Deploy : Deployment involves breaking down processes into subprocesses and educating staff on documentation, education, training tools, and metrics, with company intranets becoming increasingly utilized for this purpose

Step 3

  • Control measure : Establishing a quality management system (QMS) requires control and measurement through routine audits, varying based on the organization’s size, risk, and environmental impact.

Step 4

  • Review and Improvisation : The review and improvement process aims to assess the efficiency and effectiveness of each process, inform employees, and develop new best practices based on audit data.

Principles of QMS

Our Zenovel QMS setting up process is guided by fundamental process that ensures client satisfaction by managing processes.

PRINCIPLES OF QMS

IMPACT OF QUALITY STANDARDISATION

Having a robust Quality standardization in clinical research plays a pivotal role in ensuring the integrity, reliability, and credibility of study outcomes. Here are some of the key impacts it has:
  • Data Consistency: Standardization ensures consistent and comparable data across studies.
  • Patient Safety: Protects participants through ethical and regulatory compliance.
  • Regulatory Approval: Compliance with standards is crucial for market approval.
  • Cost Efficiency: Streamlines processes and reduces errors, saving time and resources.
  • Global Collaboration: Facilitates effective collaboration and knowledge exchange.
  • Reputation Enhancement: Builds trust and credibility among stakeholders.
  • Data Integrity: Ensures the integrity and traceability of research data.
  • Risk Mitigation: Identifies and mitigates risks associated with research.
  • Continuous Improvement: Promotes a culture of learning and optimization.
Through comprehensive approach to QMS, Zenovel ensures that CRO/pharmaceutical client can achieve high standards of quality, efficiency, and regulatory compliance.
Contact us for our tailored QMS support that contributes to the growth and success of your organizations, enabling to meet and exceed industry expectations.

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  • India
  • 906,907, Silver Radiance 4, Sarkhej - Gandhinagar Hwy, Sola, Ahmedabad, Gujarat 382481, India
  • +91-635-635-3636
  • Australia
  • 9, Blaxland Avenue,
    Cranbourne North,
    Victoria-3977, Australia
  • Brazil 
  • Rua Praia do Tubarão, Quadra C,Loteamento Eco Vilas, Lote 13 – Vilas do Atlântico 42708-730 Lauro de Freitas, Bahia, Brazil
  • Brazil 
  • R. Álvaro Müler, 932 - Vila Angelino Rossi, Campinas-SP,13023-240, Sao Paulo, Brazil.
  • USA
  • 911 Hwy 6 Hitchcock,
    Texas, 77563, USA
  • Canada
  • 215 Moorlands Crescent,
    Kitchener, Ontario N2P 0C3
  • China
  • Zhenjiang Tech Park, Shanghai China
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