What is Quality Management System (QMS)?

A Quality Management System( QMS) is a set of programs, processes and procedures needed for planning and prosecution( product/ development/ service) in the core business area of an association( i.e., areas that can impact the association’s capability to meet client conditions).

Quality Management System (QMS) in the Pharmaceutical Industry?

  • The Aim of Quality Management is to ensure that all the organization’s stakeholders work together to improve the company’s processes, products, services, and culture to achieve the long-term success that stems from customer satisfaction.
  • Pharmaceutical companies are required to determine and keep a quality control unit for their quality management under 21 CFR Part 211. A crucial part of a pharmaceutical quality management system is documentation (SOPs, procedures, policies, etc.) and controlling them to influence product safety and quality.

The Top 3 Quality Challenges for Pharmaceutical Industries

  1. Maintaining Compliance:  Compliance remains the top priority for quality teams. Failure to achieve regulatory compliance not only hinders the bottom line, but also jeopardizes patient safety and satisfaction.
  2. Improving Economic Performance:  As performance becomes a higher priority, its challenges increase. 35% of respondents reported a lack of communication and collaboration tools as a barrier to economic performance goals, which stimulates the next challenge facing quality teams.            
  3. Reducing Department Costs:  Pharmaceutical quality teams must navigate the fine line between budget constraints and the industry’s shift from compliance to performance. 31% of survey respondents reported timely data analysis and reporting capabilities as a top obstacle as sophisticated reporting capabilities can be costly.

An effective medicinal QMS will help to develop a culture of quality, support data integrity, reduce the time and cost to manage documents, identify and resolve problems in product development and preface, manage supplier quality, and insure a trained pool. Trackwise QMS software can help pharmaceutical businesses snappily and fluently become compliant by furnishing complete end- to- end quality visibility right from design to delivery.

Key Components of Quality Management

Quality Management consists of four key components, which include the following:

Quality planning The process of relating the quality norms applicable to the project and deciding how to meet them.

Quality Control

The continuing effort to uphold a process’s integrity and trustability in achieving an outcome.

Quality improvement The purposeful change of a process to ameliorate the confidence or trustability of the outcome.

Quality Assurance The structured or planned actions necessary to offer sufficient trustability so that a particular service or product will meet the specified conditions.

Best Practices for Quality Management

The following are recommended best practices for QMS:

Top 5 Tools Used

Today’s organizations have the benefit of selecting from an extensive range of cloud-based solutions for quality management, including software-as-a-service (SaaS) solutions designed specifically for their industry. Different types of Software used for QMS in Pharmaceutical Industry are as below:






QMS by Trackwise

Trackwise is a web-based quality management system for startups to large enterprises. Trackwise allows to manage quality control policies, plans, complaints, and training details in one platform. It can easily add documents, images, and links to provide proofs for incident reports. This way it can have a consolidated database for company’s confidential files. Trackwise even features risk management tools that allow to perform proactive quality management. Moreover, it is fully manageable with 21 CFR Part 11 and EU MDR 2020. Lastly, the system has audit management tools that enables to analyze business’ financial performance. Thus, Trackwise helps to manage business’s overall processes.

Trackwise Features:

Need for Trackwise QMS

  • Automate Quality and compliance Processes.
  • Validate QMS efficiently
  • Leverage AI-Augmented Decision-Making capabilities
  • Make smarter and Faster Decision.

Trackwise integration with other core applications

Trackwise QMS Quality connect allows to seamlessly connect to other business critical applications like ERP, CRM, LIMS, and MES systems. This allows to streamline workflows and responses and improve accuracy across disparate system.

Key Benefits for integration

  • Better profitability and effectiveness of quality system through seamless integration
  • Streamlined workflows and responses across data management system.
  • Flexibility and choice to meet changing requirements and business needs. 
  • An integration platform for certified Partner Application.


Though there are multiple options available for QMS, Trackwise help to improve the quality of the products and processes. This groundbreaking cloud based QMS platform features out-of-the-box workflows built from over two decades of experience and offers integrated quality event management, customer complaint handling, document management, employee training, and more. Trackwise helps to go beyond regulatory compliance, create actionable insights, optimize performance, and increase visibility.

QUALIOO Offerings

  • QUALIOO offers comprehensive Enterprise Applications Testing Services including functional, non-functional and test automation services. 

  • QUALIOO has domain and QA experience across the IT landscape enterprises including Financials, HCM, SCM, CRM, PPM, Budgeting, PLM, LMS, GRC, CSM, Marketing Automation, CPQ, ITSM, ITOM, ETL, Data Warehouse, EPM, BI and MDM.

  • We can help such organizations accelerate their Digital Transformation Journey with our Industry solution built on leading cloud- based Platform.

  • By combining cloud ERP with an industry-specific digital operations platform, pre-revenue and small to midsized life sciences firm can accelerate now verses later. 

  • Qualioo offers Xenon which reimagines QA for agile work, test automation, test case customization for setup, and can run regression packs for role changes. 

  • Qualioo Consulting provides enterprise business application implementations, integrations, software product engineering, cloud services, technology advisory, testing, and managed services across diverse industries.