Key Elements of Pharmaceutical Quality Management Systems

by | Jan 26, 2023 | Blog

Elements of quality management system in pharmaceutical industry

The pharmaceutical industry has undergone significant changes over the last decade. A greater emphasis is put on cost control, while public health concerns call for increased efficiency. This transformation has led to new challenges for quality management systems (QMS).

Applicable pharmaceutical QMS regulations and standards

All life sciences companies, such as pharma, biotech, and medical device companies, are required to comply with the Good Manufacturing Practices (GMP) requirements. These regulatory requirements ascertain that all products and services are safe, pure, effective, traceable, and reproducible.

GMP is an essential component of the Food and Drug Administration (FDA) regulatory framework. Through it, the FDA can carefully monitor the methods, facilities, and controls used in the manufacturing, processing, and packing of drug products. Compliance with GMP standards is a fundamental aspect of the approval of new and generic pharmaceuticals.

The implementation of an efficient Quality Management System (QMS) is an indispensable GMP requirement. A pharmaceutical Quality Management System is a collection of activities and processes designed to improve the quality of pharmaceutical products. It is meant to create and monitor high-quality practices across all phases of the product life cycle.

A QMS must be front-and-center during all the important phases of drug production, including:

  • Formulation
  • Method development
  • Infrastructure
  • Utility system
  • Equipment

Ensuring the creation of quality products is one of the most important facets of pharmaceutical development. Through the use of a QMS, any issues or incidents that may arise during the manufacturing process can be tracked so the appropriate preventive or corrective actions can be performed.

A pharmaceutical quality system protects patients and gives them the confidence to trust the medicines they purchase. Failure to adhere to QMS regulatory compliance can result in heavy penalties, legal issues, and product recalls, among other negative consequences.

What are the essential elements of pharmaceutical quality management systems?

To function as an effective management review application, a pharmaceutical quality management system must be able to identify deviations and help fulfill corrective and preventive actions. Additionally, a QMS can maintain an organized culture of quality by being automatically organized and fully auditable.

Quality assurance

A pharmaceutical management system must be able to monitor any event that deviates from the usual. Through a QMS, pharmaceutical companies must be able to manage any incident, issue, or complaint from the moment it happens until it has been resolved.

Processus de gestion de la qualité

A QMS is designed to manage a series of specific steps. These include the following:


The process of identifying, assessing, and correcting any departure from the approved instructions or established standards is known as Deviation Management. The term “deviation” is used interchangeably with “non-conformity” and “non-conformance”.

Common causes of deviations include human error and equipment malfunctions. However, pre-approved temporary deviations can also be undertaken by an organization to better prepare for future risk management. The deviation management process can be streamlined with an Electronic Quality Management System, drastically improving the way pharma companies can handle potential quality issues.


A QMS must supply all the documentation necessary to investigate any deviation. The majority of deviation reports are related to minor, isolated issues that can be rapidly corrected. However, they will sometimes be raised for serious issues and will be needed for standard audit observations.

Issues in need of investigation include product safety integrity, purity, efficacy, and stability. An investigation may also be made into GMP violations, customer perception, and potential complaints. Ideally, a deviation report should be produced within 2 working days of the observed event and submitted to QA Management Review. Response tasks should be performed within 5 working days.

Corrective and Preventive Action (CAPA)

These procedures are detailed guidelines designed to document quality problems and the way they are corrected. CAPA procedures also include record-keeping activities to document what measures have been taken to prevent the recurrence of issues. 

The main goals of CAPA procedures are to ensure customer satisfaction and regulatory compliance. Customers today have the opportunity to assess product quality by tracking the authenticity and validity of medicinal products. Likewise, regulatory bodies can identify if products and manufacturing activities are up to regulatory standards.

Change Control

Also known as change management, this process is used to guarantee the changes performed to a product or system are made in a controlled and coordinated manner. The aim of change control is to provide project managers, sponsors, and stakeholders with a standard process to manage modifications.

Through change control, projects can remain on schedule and within budget. Likewise, pharma companies can avoid unnecessary changes, faults in the system, and black-out activities. This process ascertains that pharmaceutical development is kept as cost-effective as possible.

Audit process management

Typically, QMS systems can be used to manage the auditing process. The appropriate implementation of a QMS system allows life science organizations to simplify the execution of both external and internal audits.

QMS software is able to provide audit reports. Audits can be performed in a proactive manner, with non-conformances being automatically released upon the approval of reports. This way, auditing tools are useful not only for compliance requirements but also to include visibility into issues with processes. QMS auditing tools simplify risk management.


QMS reporting tools are indispensable. A QMS system should be able to provide reports and metrics of how many incidents occur, at what stage were they first observed, and the time it takes to resolve them. Thanks to QMS quality management and reporting tools, compliance processes can be used for the continuous improvement of business and product development.

Improving workflows

QMS can be used to automate production, product delivery, quality management, regulatory compliance, and other processes. Each step of the development process can be connected via QMS to streamline the definition of flows, roles, activities, and business rules. Managers can use QMS to oversee processes in real-time and be notified of any delays. Platform-based QMS tools empower life science organizations to integrate processes, connect data, and hasten the arrival of quality products to the market.

Summary document generation

Proper documentation is key to maintaining good organizational efficiency. A well-realized QMS can accurately highlight an organization’s composition, practices, procedures, and quality standards. Good QMS documentation improves document management and communication processes and reduces the level of risk associated with drug development.

To be useful, a QMS system must be able to generate formal summary documents, such as audit summaries and site visit reports. Quick access to documents and records helps pharma companies easily certify the quality control of processes and finalized products.

Establishing and implementing a QMS

Adopting a QMS is the perfect opportunity to enhance the quality of all systems, from formulation to customer service. Through it, you can ensure the continual improvement of all the processes handled by your organization. However, the digital transformation of a paper-based quality management system to a modern, automated solution requires a series of steps.

In order to successfully implement QMS an organization must:

Transfer physical documents

To ensure the integrity of all information, existing paper documents must be transferred to the QMS software. This will allow a company to collect the right metadata at each step. While this process may seem long, it will guarantee that all future operations can be handled smoothly. 


Configure automated workflows

All life sciences companies have their own systematic approach to quality management. QMS software must be configured to follow the quality goals set by organizations. Once the software is properly set up, automated workflows will mirror the way issues are managed with a paper-based system. One key benefit of automatizing workflows is reaping the benefits of automatic processes. Not only are potential risks avoided, but time and effort that would otherwise go to handling documentation can be better spent on more important tasks.

Train users

Training is fundamental for the success of a digital QMS strategy. Fortunately, effective quality management systems have been designed to offer the best consumer experience. The main goal of training is to teach users how regulations and standards can be followed using the software. Quality policies that are already familiar to the staff are built into the software, making it much more intuitive.

Pharmaceutical quality management system software

Life sciences companies have two main choices when it comes to quality management systems.

Using a legacy product

A legacy QMS is designed to fulfill general-purpose office tasks. This means that it has been designed to accommodate different types of industries. This type of QMS must be set up from the ground up, as it has not been specifically set up to cater to pharmaceutical quality guidelines.

A considerable disadvantage of Legacy QMS is its reduced capacity for assessing quality objectives. Since it has not been specifically designed to cater to the pharmaceutical industry, its capacity to aid the user during risk-related activities is substantially diminished. Moreover, they will require constant reconfiguration to remain compliant with changes to the GMP.

Using a targeted solution

This type of QMS has been specifically designed to fulfill pharmaceutical customer requirements. As a product quality monitoring system tailor-made for pharma, biotech, and medtech companies, it can be used to automatically handle documentation related to the pharmaceutical manufacturing process.

Thanks to their design, pharma QMS systems can be easily integrated by all types of life sciences companies. Whether using a paper-based or Legacy QMS, pharmaceutical QMS makes the transition as painless as possible. Users don’t have to deal with inputting all their processes into the system. Instead, trials can be accelerated and the quality of test results be improved.

During a clinical research project, a state-of-the-art QMS solution can automatically capture deviations, document CAPAs, and manage change control processes. Through risk-based monitoring and perpetual quality control, a modern QMS system can drive the continuous improvement of a life sciences organization.

Agatha Quality is a QMS system at the vanguard of innovation. The software goes beyond document management and offers a complete quality management solution designed for customer satisfaction. In Agatha QMS, one can find a complete toolset for quality managers, ready to use and easy to adapt to any company’s specifications. 

Users of Agatha Quality can make use of readily-available standard forms and processes or adapt them according to their specific requirements. Through complete metrics and reporting available from a dynamic user interface, users can create customized reports and easily deliver them.

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