What is Quality Management System?

A QMS, or Quality Management System, is a set of procedures and processes that ensure the quality of pharmaceutical products. It is a systematic approach to managing quality throughout the product lifecycle, from development to manufacturing to distribution.

At Proven Tech , we believe that quality is the cornerstone of success. We are committed to helping businesses thrive by implementing robust Quality Management Systems (QMS) that not only meet industry standards but exceed them. With a proven track record of enhancing efficiency, reducing risks, and increasing customer satisfaction, our QMS solutions are designed to drive your organization towards excellence.

What is a Quality Management System (QMS)?

A Quality Management System (QMS) is a structured framework that helps organizations manage and improve their processes to consistently deliver high-quality products and services. It provides a systematic approach to quality control, ensuring that businesses meet customer expectations, comply with regulations, and continuously strive for improvement.

Why QMS?

In today's competitive business landscape, QMS is no longer a choice but a necessity. It empowers companies to:

Enhance Customer Satisfaction:

By consistently meeting or exceeding customer expectations, your organization can build trust and loyalty, leading to increased customer satisfaction and retention.

Optimize Processes

QMS helps streamline operations, reduce waste, and enhance efficiency, leading to cost savings and improved productivity.

Comply with Regulations:

QMS ensures that your business stays in compliance with industry and regulatory standards, reducing the risk of fines, legal issues, and reputational damage.

Drive Continuous Improvement:

With QMS, you'll have a framework for ongoing assessment and refinement, enabling your business to adapt to changing market conditions and remain competitive.

Our QMS Services

At ProvenTech, we specialize in providing comprehensive QMS solutions tailored to your industry and unique business needs. Our services include:

QMS Implementation: We will help you design and implement a customized QMS to suit your organization's requirements, guiding you through the process from start to finish.

Continuous Support: Your success is our priority. We offer ongoing support and consultation to ensure your QMS remains effective and adaptable to your evolving business environment.

key features

Role-based access control: This allows users to only access the information that they need to do their job, which helps to protect sensitive data.

Configurable: The process, data, documentation etc., is configurable as per customer requirement

Audit trail This records all changes that are made, which helps to ensure that the data is accurate and reliable.

Version control: This allows users to track changes that are made, which helps to ensure that the data is not lost or corrupted.

Search and filtering capabilities: This allows users to quickly and easily find the LIRs that they need.

High Productivity Speed, Efficiency, and GxP compliance with our integrated suite of quality applications.

Accelerate Work Increase operational efficiency with automated workflows and customized practices.

Change Control Management System:

Change control is a systematic process for managing changes to a pharmaceutical company's products, processes, or systems. It is an essential part of quality management in the pharmaceutical industry, as it helps to ensure that changes are made in a controlled and compliant manner.

Eminent’s Change Control Management system helps a company to

  • Ensure that changes are made in a controlled and compliant manner.
  • Prevent quality problems and regulatory compliance issues.
  • Improve communication and collaboration between different departments within the company.
  • Track the history of changes and to identify any potential risks.
  • Ensure that all changes are documented and approved by the appropriate personnel.

Corrective Action and Preventive Action (CAPA) Management system:

CAPA is a systematic process for identifying and addressing problems in a pharmaceutical company's products, processes, or systems. The goal of CAPA is to prevent quality problems from recurring and to improve the overall quality of pharmaceutical products.

Eminent’s CAPA Management system helps a company in

  • Preventing quality problems from recurring
  • Improving the overall quality of pharmaceutical products.
  • Meeting regulatory requirements.
  • Enhancing patient safety
  • Enhancing customer satisfaction.

Incident Management system:

An incident in the pharmaceutical industry is an unexpected or unplanned event that does not have a direct impact on the product or production activity. Incidents can include things like equipment breakdowns, power outages, or employee injuries. They can also be caused by human error, but they do not have the same potential consequences as LIRs (laboratory incident reports).

Eminent’s Incident Management System helps a company to

  • Identify and investigate incidents quickly
  • Resolve incidents as quickly and effectively as possible, while minimizing the impact on operations.
  • Identify and investigate the root cause for the incident and take appropriate corrective and preventive actions (CAPA).
  • Meet regulatory requirements

Laboratory Incident Report (LIR) Management system:

It is an unexpected or uncontrolled event that occurs in a laboratory during the analysis of a pharmaceutical product. LIRs can be caused by human error, instrument malfunction, or other factors. They can have a variety of consequences, including the release of a contaminated product, the loss of data, or the injury of an employee.

Eminent’s Laboratory Incident Report Management system helps a company to

  • Reduce the risk of product recalls, fines, and other legal issues.
  • Improve efficiency and productivity.
  • Improve communication between different departments within a pharmaceutical company.
  • Ensure that incidents are investigated thoroughly and that corrective and preventive action is taken quickly.
  • Comply with regulatory requirements.

Out of Specification (OOS) Management system:

OOS is a result that falls outside of the predetermined specifications or acceptance criteria set by the manufacturer or laboratory.

OOS results are important to investigate because they can indicate a problem with the quality of a pharmaceutical product. By investigating OOS results, pharmaceutical companies can identify and address problems that could impact the safety and efficacy of their products.

Eminent’s OOS Management System helps a company to

  • Ensure quality of the product.
  • Reduce the risk of product recalls and other quality problems.
  • Investigate and document OOS in compliance with regulatory standards.
  • Ensure patient safety
  • Improve customer satisfaction

Eminent is a robust QMS application with endless possibilities of customizations that meet the requirements of the industry and improved compliance.

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