Importance of QMS in the Pharmaceutical Industry


Over the once many times, the global pharmaceutical market has experienced drastic changes, forcing pharmaceutical companies to concentrate on client requirements and upon their own internal effectiveness to insure quality and compliance throughout the pharmaceutical demand chain.

Besides, the FDA and other regulatory bodies such as Good Manufacturing Practice (GMP) and EN ISO 9001 Quality Management System (QMS) are focused not only on the importance of building a culture of quality management but on compliance in the pharmaceutical industry.

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.

Additionally, pharmaceutical companies also comply with 21 CFR Part 11, the FDA guideline that applies to all FDA- governed industries for electronic records and electronic signatures, ensuring their authenticity and reliability, while being as comprehensive as paper records. A pharmaceutical quality management system should cover these key aspects of Part 11: audit logs & tracking, the guidelines and rules for storage, copying, access & permissions, version control of the electronic records, and electronic signature application.

Key Components of Quality Management

Quality management is the act of overseeing different activities and tasks within an organization to ensure that products and services offered, as well as the means used to provide them, are consistent. It helps to achieve and maintain a desired level of quality within the organization.

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

  • 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.
  • The Process of Quality Management involves a collection of guidelines that are developed by a team to ensure that the products and services that they produce are of the right standards or fit for a specified purpose.
  • The process starts when the organization sets quality targets to be met and which are agreed upon with the customer.
  • The organization then defines how the targets will be measured. It takes the actions that are required to measure quality. It then identifies any quality issues that arise and initiates improvements.
  • The final step involves reporting the overall level of the quality achieved.
  • The process ensures that the products and services produced by the team match the customers’ expectations.

Quality planning The process of identifying the quality standards relevant to the project and deciding how to meet them.

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

Quality improvement The purposeful change of a process to improve the confidence or reliability of the outcome.

Quality Assurance The systematic or planned actions necessary to offer sufficient reliability so that a particular service or product will meet the specified requirements.

Best Practices for Quality Management

The following are recommended best practices for Quality Management:

  • Document – Quality measures and metrics should be centrally documented.
  • Involve Stakeholder – Involve project participants and stakeholders in the identification and definition of project quality standard.
  • Solicit Feedback – Solicit feedback from the project team, customers and stakeholders regarding quality metrics, proposed measures, and quality baselines.
  • Be Proactive – Focus on detecting and addressing quality early in the project life before it becomes an issue.
  • Iterative– Project Quality Management is an ongoing, iterative process that is conducted throughout the project lifecycle.
  • Track Trends – Trend Quality metrics and measures over time to provide a graphical representation of the trend of the project’s conformity to define quality standards.
  • Review – A regular review of quality standards, metrics, measures is good project management practices. Depending on the complexity of the project the review process may happen daily but should happen at least weekly for even the simplest projects.
  • Thresholds – Establish agreed upon thresholds that define when certain corrective action needs to be taken to bring project performance back within acceptable boundaries of performance which are outline within QMP.
  • Analysis – Analyze the impact on the product, project, and program.
  • Act Quickly – Obtain quality feedback as quickly as possible to avoid escalation of potential quality issues.
  • Archive Quality – Quality measures and metrics should be archived as historical project data and incorporated into the organization’s lessons learned.
  • Disseminate Quality – Disseminate appropriate quality measures and metrics data to the project team and appropriate stakeholders.
  • Continuous Improvement – Constantly look for ways to increase project quality.

The Top 3 Quality Challenges for Pharmaceutical Industries

  1. Maintaining Compliance

    Compliance remains the top priority for quality teams. Manufacturers in the life sciences must comply with complex and rapidly evolving industry regulations to sell and market products. Failure to achieve regulatory compliance not only hinders the bottom line, but also jeopardizes patient safety and satisfaction.  In addition to rapid response to evolving industry regulations, 48 percent of survey respondents reported challenges of limited headcount and budget constraints. While compliance has been the top priority of quality teams for years, recent trends suggest that firms are able to check the compliance box by focusing on economic performance.


  2. Improving Economic Performance

    Though compliance reigns king, firms are beginning to move towards performance-based quality due in part by Industrial Transformation.  In fact, 39 percent of pharmaceutical manufacturers cited economic performance as a top priority. As performance becomes a higher priority, its challenges increase. 35 percent 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

    In the Digital Era, quality teams recognize the value of innovative technology and accurate data for process automation, centralization, and integration. Pharmaceutical quality teams must navigate the fine line between budget constraints and the industry’s shift from compliance to performance. 31 percent of survey respondents reported timely data analysis and reporting capabilities as a top obstacle as sophisticated reporting capabilities can be costly.  Data remains the foremost driver for quality improvement, sparking the need for greater tech investments, and ultimately, cost cutting. 15 percent of survey respondents plan to purchase an integrated enterprise quality management system in the next 12-16 months, and 12 percent assert that a cloud-based/digital platform is a top consideration for tech investments.

An effective pharmaceutical QMS 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 workforce. Trackwise QMS software can help pharmaceutical businesses rapidly and fluently become compliant by furnishing complete end- to- end quality visibility right from design to delivery.

Types of Software’s used for QMS

In years past, QMS solutions were primarily homegrown solutions designed specifically for the requirements of an enterprise. “QMS adoption” was an incredibly costly and complicated venture which required years of effort to gather requirements, develop the software, and roll it out across the organization.

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. The best QMS software is designed to offer deep value for specific business scenarios, such as global enterprises with an extensive product portfolio or startups focused on research and development.

Different types of Software used for QMS in Pharmaceutical Industry are as below:

  1. Pilgrim:  SmartSolve is a QMS software solution by Pilgrim, an IQVIA company which is marketed as a comprehensive solution for managing compliance, risk, quality, and the supplier chain in the life sciences sector.                                                                                          
  2. Qualityze:  Qualitize includes a full range of QMS features for managing documents, nonconformances, customer complaints, suppliers, audits, and other activities required to comply with FDA cGMP, ISO 13485, Pharmaceuticals and Medical Devices Agency (PMDA), and Therapeutic Goods Administration (TGA).                               
  3. Trackwise:  Sparta Systems’ TrackWise product is a QMS software designed for organizations that are subject to GMP requirements. The vendor positions the product as a comprehensive QMS solution designed to increase visibility and improve organizational efficiency in a competitive market.                         
  4. Master controlThis QMS is a well-known brand in the life sciences industry, and among the most widely adopted solutions in the vertical. Solutions offered within MasterControl are designed to address compliance and quality management in product development, clinical trials, supplier management, regulatory risk management, manufacturing, and post-market use cases.                             
  5. Qualio:  This cloud-based eQMS is designed to help simplify comprehensive quality management at life sciences organizations involved in the development, production, and distribution of pharmaceuticals, medical devices, and biotechnology products.


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. The software also ensures that all products underwent every step of the quality management process. This program then helps in limiting complaints about products and services. Trackwise even features risk management tools that allow to perform proactive quality management. Also, it’s fully compliant 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

Main features of Trackwise are:

  • Change control

  • Document Management

  • Supplier Quality Management

  • Compliant Management

  • CAPA Management

  • Audit Management

  • EH&S Management

  • Product Registration

  • Training Management

  • Out of Specification Management

  • Recall Management

  • Deviation Management

Why Trackwise?

The main benefits of Trackwise are automated business processes, integrated systems, and in-depth analytics.

  • Automated business processes

Trackwise is a quality management software that automatically categorizes quality events and complaints. This process is possible since the software utilizes artificial intelligence  technology. With Trackwise you can quickly sort your files and documents.

Also, the program allows your business to limit homemade processes. This way, you can avoid human- caused errors, similar as double entries and deficient data input. Hence, Trackwise helps improve your company’s productivity.

  • Integrated systems

Since Trackwise is cloud-based, your business data can be accessed through any device with an internet connection. This functionality provides a unified database for files, reports, events, and complaints. The program indeed eliminates the need for a physical storehouse of nonpublic documents.

Also, this program’s web- based point enables you and your team members to unite on tasks seamlessly. You can edit and note on documents anytime and anywhere.

  • In-depth analytics:

The software supplies you with upgrade and comprehensive business reports. You can also view and review these analytics fluently through the search navigation tools. Trackwise lets you assess each project with data- backed information. Hence, the platform helps you to make further intelligent business decisions.

Device Supported

  • Web based

Customer types

  • Small Business
  • Medium Business
  • Enterprise

Support types

  • Phone
  • Online

QUALIOO Offerings

  • Life Sciences & Healthcare companies are quickly adapting to Digital Solutions supporting Modern Enterprise needs to efficiently manage product Life cycles across Business functions frommid-market to Large Enterprise clients.

  • 250+ Companies use Qualioo Consulting for their Growth. Qualioo Consulting have worked with a range of industries and businesses, helping them grow and create value through their service.  

  • At Qualioo Consulting we understand that Traditional IT Systems aren’t Scalable, Agile and lack latest Technology enablers to handle the above requirements. We can help similar associations accelerate their Digital Transformation Journey with our Industry solution built on leading cloud- based Platforms.