Partner with us
Submit RFP
Partner with us
Submit RFP

QMS Setup

Integrating Quality at Every Step with our Expert QMS configuration for Unmarked GCP Compliance

Zenovel : Driving Quality, Ensuring Your Success

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 organizationmeet customer and regulatory requirements, and enhance operational efficiency.

  • Benefits of QMS with Zenovel

Implementing a quality management systemwith 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 witha 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.

  • Principles of QMS

OurZenovel QMS setting up process is guided by fundamental process that ensuresclient satisfaction by managing processes.

  • 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.

Reach out to us for any inquiries or support needs.
Contact us

Blogs and news

Our Latest Article

Nitrosamine Control

FDA’s Approach to Nitrosamine Control: Innovative Solutions for Drug Safety and Compliance

Understanding Nitrosamine Impurities in Pharmaceuticals: Nitrosamines, particularly N-nitrosamines, are probable or possible human carcinogens. They can form during the synthesis of active pharmaceutical ingredients (APIs) or during the storage of finished drug products. FDA guidance emphasizes the need for risk assessment, mitigation strategies, and regulatory compliance to control nitrosamine levels.

Read More
Nitrosamine Control

In-Process Monitoring for BA/BE Studies: A Focus on DDIs

Introduction: In-process monitoring is a critical component of ensuring the quality and reliability of BA/BE studies, especially those involving drug-drug interactions (DDIs). For DDI studies, in-process monitoring is particularly crucial due to the complex nature of interactions, the need for precise data, and the potential impact on patient safety. Key

Read More
Risk-Based Monitoring

Revolutionizing Clinical Trial Monitoring: The Power of Risk-Based Monitoring (RBM)

Abstract For the past few years, regulatory bodies, industry advocacy groups, and private companies have been tackling the concept of incorporating risk into the design of clinical trials and customizing monitoring strategies based on those risks to achieve higher-quality outcomes. Regulatory guidance like ICH and FDA encourag sponsors to adopt

Read More
Mastering Inhalation Studies

Mastering Inhalation Studies: A Closer Look at Challenges and Solutions

Introduction In the realm of inhalation studies, achieving consistent compliance and accurate results is a considerable challenge due to the complexities associated with trial conduct. Zenovel, a third-party monitoring company, boasts extensive experience in monitoring inhalation studies. This article sheds light on Zenovel’s recent involvement in the monitoring of three

Read More
Data integrity

Ensuring Data Integrity: Best Practices and Considerations

Introduction There are multiple definitions of data integrity, yet the essence is the same. Data integrity is the overall accuracy, completeness, and consistency of data. Data integrity is the maintenance of, and the assurance of the accuracy and consistency of data over its entire life-cycle and is a critical aspect

Read More
GCP Audit and Monitoring

Enhancing Clinical Studies with GCP Audit and Monitoring

Understanding GCP Audit and Monitoring GCP guidelines set forth by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) provide a framework to ensure the ethical conduct, safety, and quality of clinical trials. Audit and monitoring are essential components of GCP compliance and play a

Read More
We provide affordable, innovative, and high-quality solutions to pharma industry with ethics driven research and increasing accessibility to high quality medicine worldwide
Youtube-square

Useful Links

Company

Contact Us

  • India
  • 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
Copyright © 2024 Zenovel. All rights reserved.
Partner with us
Submit RFP