For all industries, a Quality Management System (QMS) is essential to formalize the processes, procedures, and responsibilities to place safe and high-quality products on the market.
In the Life Sciences industry, compliance with relevant requirements is highly regulated by regulatory bodies to ensure products are safe for their intended use.
This article will discuss what a QMS is in Life Sciences, its importance and major components, some requirements, and the role of an eQMS in achieving compliance.
SimplerQMS provides QMS software designed specifically for the Life Sciences industry. We offer all Life Science QMS modules in one system to streamline processes such as document control, change control, employee training, audits, non-conformance/deviation, CAPA management, and more.
Book a personalized demo and talk to our experts if you want to learn more about how SimplerQMS can benefit your company.
- What is a Quality Management System in Life Sciences?
- Importance of QMS for Life Sciences
- Major Components of a Life Science QMS
- Quality Management System Requirements in Life Sciences
- Role of Life Science QMS Software
What is a Quality Management System in Life Sciences?
A Quality Management System (QMS) is a set of interrelated elements of a company to establish quality policies, processes, procedures, and objectives.
The QMS of a company needs to reflect the specific requirements applied to them.
In the Life Science sector, companies operate in pharmaceutical, medical devices, biotechnology, and other industries focused on living organisms such as plants, animals, or humans.
Companies operating in these industries must comply with the applicable requirements for their product type, market, and country in which they operate.
Life Sciences requirements usually involve several quality processes with different emphases depending on the specific requirement, such as:
- Document management
- Change control management
- Employee training management
- Complaint management
- Equipment management
- CAPA management
- Audit management
- And so on
SimplerQMS supports Life Sciences quality management processes in one system. Our QMS modules are interlinked to provide a seamless workflow.
For instance, a company can identify a quality issue that also requires an escalation to CAPA. This can then lead to updating a document with a change request and providing retraining to relevant employees.
This article will give an overview of a QMS for Life Sciences. If you are interested in learning more about a specific QMS, read our articles:
Importance of QMS for Life Sciences
Quality is one of the most important aspects of Life Sciences, as it directly affects the safety and efficacy of products. QMS provides an organized and comprehensive system to control the processes and ensure products are safe for their intended use.
Here are other important reasons to have a QMS in Life Sciences:
Increased Workflow Efficiency
A quality management system helps to streamline the processes, procedures, and responsibilities for achieving quality objectives. All employees are aware of the procedures they should follow and the roles they need to play.
This also allows for improved productivity and resource optimization, which we will discuss later in the article.
Reduction Quality Issues
Management of quality issues such as non-conformances, deviations, and complaints is a requirement for Life Science QMS.
Having documented processes and procedures for these allows for systematic and effective identification, investigation, and resolution of any quality issues.
This results in reduced quality issues and continuous improvement of products and services.
Decrease In Costs and Time to Market
An organized and well-described set of documents can decrease cost and time to market by:
- Mitigating quality issues
- Preventing rework or additional work
- Reducing the risk of regulatory problems
Streamlined Internal Communication
A quality management system helps everyone in the company to understand their roles and responsibilities. It ensures that everyone is working towards the same goal, communicating effectively with each other, and following up-to-date on best practices.
It also reinforces accountability and responsibility, which leads to increased process consistency and improved product quality.
Evidence-Based Decision Making
The use of Life Sciences QMS helps to store, track, and analyze data easier, faster, and more accurately. This facilitates evidence-based decisions by collecting the pieces of evidence needed to make informed decisions aligned with quality objectives.
Depending on the size of the company, level of digitization, available resources, and the complexity of its operations, a QMS may be in a paper-based format, hybrid, or electronic.
An Electronic Quality Management System (eQMS) can help Life Science companies efficiently manage their processes and documentation.
SimplerQMS offers an eQMS designed for the Life Science industry, with preconfigured workflows based on the Life Science requirements to help companies streamline quality management processes. The system provides interlinked QMS modules for more seamless work.
It reduces the time spent on paperwork by automating document management tasks while providing an audit trail of all document changes.
By using an eQMS, companies help ensure the accuracy of records and compliance with applicable industry requirements.
Major Components of a Life Science QMS
The major components of a QMS are the policies, processes, procedures, work instructions, and records.
Specific industry, product, and market requirements will be reflected in the components of the QMS. For instance, regulations for sterile drug products vary significantly from surgically invasive medical device requirements, and the QMS must be adequate to their needs.
Generally, the requirements for records in Life Science are more comprehensive and stricter than in other industries. There is an emphasis on documenting relevant steps in a procedure and who was the responsible person.
The documents inside a QMS support each other in a workflow hierarchy. This helps employees to know their importance in the workflow and the responsible persons for specific tasks.
A quality policy is a requirement for a QMS. It specifies the company’s intentions and directions related to quality objectives.
It is usually a brief statement that shows the top management’s commitment to compliance with applicable requirements. It provides a framework for setting quality objectives and can be aligned with the company’s vision and mission.
The process is a set of activities used to achieve an intended result. In Life Sciences, processes are planned and carried out under controlled conditions.
Controlling processes involves a high volume of documents to be created, reviewed, approved, signed, updated, and archived constantly.
Robust document control solution, such as the one in SimplerQMS, helps Life Sciences companies to ensure process documentation is controlled in compliance with the applicable requirements.
The system offers preconfigured workflows customized for Life Sciences to help streamline the company’s operational efficiency and documentation processes.
For instance, you can capture the electronic signatures of responsible persons regarding the review and approval of documents and have all actions automatically recorded in a complete time-stamped audit trail.
Procedures specify how to carry out a process. It is essential to ensure the consistency of the activities and produce a high and uniform quality product.
Due to its importance, changes in procedures are critical. Not following validated procedures can result in quality issues and non-compliance with relevant requirements.
An important element of QMS is employee training to ensure each person is aware of procedures and has the competence to perform their functions.
Using the training management module in SimplerQMS, you can link documents to persons and departments and have them automatically get notified regarding retraining when updates occur.
By using quizzes, it is possible to have training assessments and check training effectiveness more effectively than just reading and signing documents.
Work Instructions are documents that provide a detailed step-to-step way for completing the tasks and complying with the processes.
Life Sciences companies need to ensure relevant versions of work instructions are available at points of use, identifying the current revision status and controlling changes to documents.
To help companies create work instructions and any other documents, SimplerQMS offers a document template package based on Life Science requirements. The software automatically performs document versioning and records the time and person responsible for any document modification.
SimplerQMS also offers a change management module to streamline the control of changes in relevant documents. The software simplified updating documents by easily creating change requests, assigning review and approval tasks to specific persons, and capturing electronic signatures to record responsibilities and justifications.
Records provide evidence of the activities performed and the results achieved. They can formalize traceability in the form of document histories and audit trails.
Life Science companies usually handle a high volume of data and documents. Keeping track of all information is essential for compliance. For example, companies need to provide specific files and documents to regulatory authorities during inspections and audits.
An eQMS like SimplerQMS helps companies organize and control documents by creating document collections to compile all relevant data easily, for instance, when compiling technical documentation.
You can create collections with specific historical versions of documents. Or you can have a collection that is always up to date with the most recent versions of each document.
It is also possible to easily search documents using keywords in titles and content. This feature facilitates the retrieval of documents during audit situations.
Quality Management System Requirements in Life Sciences
There are different QMS requirements in Life Sciences depending on the country, and market companies want to sell their products.
This article will briefly mention just a few of the many QMS requirements in the Life Sciences industry. Information here is for educational purposes only. Always refer to the regulations, standards, and guidelines applicable to your company.
QMS Requirements for the Pharmaceutical Industry
In the pharmaceutical industry, a general QMS standard used by many companies is ISO 9001:2015. This standard specifies the requirements for a QMS that can help to improve overall performance and provide a sound basis for sustainable development initiatives.
For a specific pharmaceutical quality system, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) developed the guideline Q10. This guide describes a model for an effective QMS for the pharmaceutical industry, referred to as the ICH Q10 Pharmaceutical Quality System.
Other important requirements are related to Good Practices (GxP), such as Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Distribution Practices (GDP), Good Clinical Practices (GCP), and so on.
Specifically, the GMP helps ensure companies control and document their processes to manufacture drug products with high and uniform quality.
Some regulations regarding GMP for pharmaceutical companies in the United States include FDA 21 CFR Part 210, 211, and 212. These regulations specify the current Good Manufacturing Practices (cGMP) requirements, which are the most updated GMP.
In Europe, the EU GMP EudraLex volume 4 compiled the GMP requirements in a comprehensive guide referring to other regulations and guidelines, including Directive 2003/94/EC for human use of medicinal products.
The EU GMP also includes international guidelines from the ICH, for instance, guideline Q7, a GMP guide for active pharmaceutical ingredients.
If you are interested in learning more, please read our article on how GMP compliance is reflected in QMS.
QMS Requirements for the Medical Devices Industry
The medical device industry is highly regulated, and many requirements are in force worldwide. Each market has its specific requirements and terminologies.
For example, an important requirement is the international regulatory standard ISO 13485:2016. It can be used by an organization involved in one or more stages of a medical device’s life cycle regarding requirements for QMS.
Please read our article on ISO 13485:2016 compliant QMS and the role of an eQMS to learn more about this regulatory standard.
In the United States, the FDA 21 CFR Part 820 is responsible for the quality system regulation for medical devices.
You can also read our article on 21 CFR Part 820 Quality System Regulation to learn more about the main requirement and the role of an eQMS.
Other relevant regulations are the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR), specifying the requirements for placing medical devices for human use in Europe on the market.
It is interesting to notice the difference in terms of EU and US regulations. The MDR and IVDR refer to the device’s documentation as technical files. In contrast, FDA regulations refer to similar documents such as:
QMS Requirements for the Medical Laboratories Industry
Requirements for medical laboratories are important to ensure accurate and reliable results since decisions on patient treatment are made based on laboratory results.
Many medical laboratories also comply with the QMS requirements in the ISO 9001:2015 standard to demonstrate their ability to provide consistent results that meet customer and applicable regulatory requirements.
Another very know requirement in the medical laboratory industry is the international standard ISO 15189:2022. It aims to promote the welfare and satisfaction of patients and laboratory users through confidence in the quality and competence of medical laboratories.
You can read our article about ISO 15189 to learn more about this standard.
In the United States, medical laboratories must comply with the Clinical Laboratory Improvement Amendments (CLIA), whose requirements are specified in regulation 42 CFR Part 493. It aims to ensure the accuracy and reliability of testing in all laboratories that perform testing on humans.
Role of Life Science QMS Software
Due to specificities in each of the Life Science industries, several QMS requirements and guidelines have been established to ensure safe, high, and uniform quality products are placed on the market.
Companies can manage their QMS manually, given the required resources to handle the manual paperwork are available.
However, as the number and complexity of regulatory requirements increase, it becomes difficult to manage all quality system processes. In addition, manual paperwork can lead to errors and inconsistencies.
Nowadays, many companies are increasingly going through an eQMS implementation process. Using a modern and comprehensive eQMS offers many benefits, such as improved workflows, reduction of time and costs, cloud-based storage of documents, simplifying regulatory compliance, and so on.
SimplerQMS offers QMS software designed for the Life Sciences industry. Our system helps companies to streamline quality processes and supports them in achieving compliance.
We offer a state-of-the-art document management system to formalize all documentation activities. The software simplifies document creation, versioning, review, approval, and document search in one secure place.
All our QMS modules are interlinked and may be tailored to the specific needs of companies in the Life Science sector. Easily link complaints, CAPAs, training, and more.
The system is fully validated according to ISPE GAMP5 and is re-validated upon the creation of a new version or upon applying standard updates.
It is also compliant with FDA 21 CFR Part 11, which sets the guidelines for electronic signatures and electronic records, as well as EU GMP Annex 11, which provides good manufacturing guidelines for computerized systems.
The benefits of an eQMS might be clear to you now regarding compliance and streamlined workflows. However, understanding the time and cost saved is essential to decide to allocate a budget and implement an eQMS.
If you want to understand better how the investment in quality management software can benefit your company, download our eQMS Business Case template. This will help you present decision-makers concrete evidence of the investment in an eQMS.
The Life Sciences industry has many requirements specific to the type of product, market, and country companies wish to operate.
An efficient Life Sciences QMS supports the processes and reflects the requirements applicable to a company. This helps ensure regulatory compliance and the placing on the market of safe, reliable, high, and uniform quality products.
Companies can use traditional QMS depending on their size and the resources available for manual paperwork. However, many companies are implementing eQMS solutions due to their many benefits.
SimplerQMS provides Life Sciences eQMS software that helps companies manage high volumes of documents more efficiently.
The system helps companies streamline their quality processes and achieve compliance with Life Sciences requirements.
Learn more about how SimplerQMS can support your company Life Sciences QMS, book a personalized demo and talk to our experts today.