Biotechnology Quality Management System (QMS) is a formalized system that includes policies, processes, and procedures utilized by biotechnology companies to ensure product quality and support regulatory compliance.
The purpose of a QMS in the biotechnology industry is to ensure the consistent manufacture of products in compliance with the applicable regulatory and customer requirements.
The biotechnology QMS is designed to manage and control all aspects of product development, manufacturing, testing, distribution, and post-market surveillance to ensure the safety, efficacy, and reliability of biotechnological products.
Biotechnology encompasses several industries, such as medical, agricultural, industrial, and environmental, among others. This article is focused on medical biotechnology, including the pharmaceutical, medical device, and diagnostics industries.
Several relevant regulations, standards, and guidelines outline the requirements for implementing a QMS in the biotechnology manufacturing industry, such as ISO 9001:2015, ISO 13485:2016, Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), FDA 21 CFR Part 210, 211, and 820, MDR, IVDR, ICH Q10, and more.
These QMS requirements outline the methods for managing quality management system processes to ensure compliance with regulatory and customer requirements. Primary QMS processes within a biotechnology QMS include document control, change control, training management, audit management, CAPA management, supplier management, and others.
SimplerQMS provides quality management software tailored to the Life Science industry, including biotech companies. Book a Demo to learn how SimplerQMS streamlines quality management processes.
What Is a Quality Management System (QMS) in Biotechnology?
A Quality Management System (QMS) in biotechnology is a structured system composed of policies, processes, procedures, and instructions. Quality Management System is essential to supporting regulatory and customer compliance and ensuring the uniform and high quality of manufactured products.
The biotechnology QMS aims to manage the entire manufacturing process of products, ensuring quality, safety, and compliance. An efficient biotechnology QMS promotes enhanced customer satisfaction, improved quality processes, compliance with requirements, and improved business profitability.
Essential QMS processes in biotechnology encompass document control, change control, training management, audit management, supplier management, incident management, CAPA management, and others.
The paper-based format for managing QMS processes involves physical documentation, such as printed procedures, forms, and records. Documents are manually filled out, reviewed, and stored. Paper-based QMS often requires extensive manual effort for document control, distribution, and retrieval, leading to potential inefficiencies, errors, and delays.
An Electronic Quality Management System (eQMS) provides a digital solution for managing QMS processes. With an eQMS, all QMS-related documents, processes, and data are digitized and stored inside the cloud or on-premise server-based software.
The eQMS streamlines and automates QMS processes. eQMS software often offers features such as automated workflows, electronic signatures, and reporting capabilities, which help to manage QMS processes, improve traceability, and support compliance.
SimplerQMS is a fully GAMP 5-validated eQMS designed to streamline operations for biotechnology companies. SimplerQMS integrates all QMS modules to improve operational efficiency and support compliance with regulatory and customer requirements.
What Are the Relevant QMS Requirements in the Biotechnology Industry?
The biotechnology industry is highly regulated due to its products’ impact on human health. Various QMS requirements are essential for ensuring the safety, effectiveness, and reliability of biotechnological products and processes.
Some of the relevant QMS requirements in the biotechnology industry are discussed below.
NOTE
This section will discuss some relevant QMS requirements in the biotechnology industry. However, this is not an exhaustive list. Please always refer to the applicable regulations, standards, and guidelines for official information.
ISO 9001:2015
ISO 9001:2015 is an international standard for quality management systems. ISO 9001:2015 outlines the requirements for establishing, implementing, maintaining, and continuously improving a QMS. The ISO 9001:2015 applies to all types of industries, including biotechnology.
ISO 9001:2015 provides the biotechnology industry with a framework for ensuring consistent quality in processes related to research, development, manufacturing, and distribution of biotechnological products.
ISO 13485:2016
ISO 13485:2016 is an international regulatory standard that defines requirements for a quality management system in companies providing medical devices and related services. ISO 13485:2016 outlines the requirements for the design, development, production, installation, and servicing of medical devices. ISO 13485:2016 applies when a biotechnology company must comply with customer and regulatory requirements.
ISO 13485:2016 is essential for companies involved in developing and manufacturing medical devices, including biotechnological devices. ISO 13485:2016 compliant QMS helps ensure that biotechnological medical devices comply with regulatory requirements for safety, efficacy, and quality.
Good Manufacturing Practices (GMP)
Good Manufacturing Practices (GMP) is a set of regulations, standards, and guidelines established by regulatory agencies, such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). GMP outlines the requirements for the manufacturing, testing, and quality control of pharmaceuticals, biologics, medical devices, cosmetics, and food products.
In the biotechnology industry, having a QMS compliant with GMP is essential for ensuring the quality, safety, and efficacy of biotechnological products. GMP regulations cover various aspects of manufacturing processes, facilities, equipment, personnel, documentation, and quality control measures.
US GMP
US GMP refers to the GMP requirements set forth by the FDA in the United States, which companies involved in developing and manufacturing biotechnology products must comply with. While biotechnology companies do not have specific GMP requirements, they often comply with the same GMP applicable to pharmaceutical, medical device, and biological products.
For instance, US GMP requirements include the Current Good Manufacturing Practices (CGMP) for pharmaceuticals in 21 CFR Parts 210 and 211, the quality system regulation for medical devices in 21 CFR Part 820, and CGMP for biological products in 21 CFR Parts 600 through 680.
EU GMP
The European Union’s GMP requirements encompass a series of guidelines defined by EMA to ensure the quality, safety, and effectiveness of medicinal products. Similar to US GMP, European biotechnology companies must comply with EU GMP requirements applicable to pharmaceuticals, medical devices, and biological products.
For example, EU GMP requirements for medical devices are reflected in the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) and the manufacturing of biological products in the EudraLex Volume 4 Annex 2.
Good Laboratory Practices (GLP)
Good Laboratory Practices (GLP) are regulations, standards, and guidelines for conducting non-clinical laboratory studies. GLP outlines the requirements for planning, executing, monitoring, recording, reporting, and archiving laboratory studies.
In the biotechnology industry, laboratory QMS compliance with GLP is critical for ensuring the integrity, reliability, and validity of non-clinical laboratory studies conducted during the research and development of biotechnological products. GLP regulations help ensure that study data are accurate and reproducible, supporting product development and regulatory submissions.
FDA 7 CFR Part 340
The FDA 7 CFR Part 340 outlines the requirements for the movement of organisms that have been modified or produced through genetic engineering. The 7 CFR Part 340 includes requirements related to permits, record retention, confidential business information, costs, and charges.
The 7 CFR Part 340 aims to minimize potential risks associated with the introduction of genetically modified organisms (GMOs) in the environment. The regulation requires biotechnological companies to whom this regulation applies to perform risk assessments before GMOs can be released into the environment.
Compliance with 7 CFR Part 340 helps safeguard public health and the environment from potential unintended consequences of GMOs.
FDA 21 CFR Part 210
The FDA 21 CFR Part 210 regulation outlines the current Good Manufacturing Practices for manufacturing, processing, packaging, and holding drugs intended for human use.
The 21 CFR Part 210 sets forth requirements for maintaining quality and consistency in the manufacturing processes of pharmaceuticals within the biotechnology industry.
FDA 21 CFR Part 211
The FDA 21 CFR Part 211 regulation specifies the current Good Manufacturing Practices for finished pharmaceuticals, including requirements related to facilities, equipment, controls, documentation, and production.
21 CFR Part 211 provides requirements for producing, controlling, and distributing finished pharmaceutical products in the biotechnology industry. Compliance with 21 CFR Part 211 ensures that biotechnological pharmaceuticals are manufactured with high and uniform quality and safety.
FDA 21 CFR Part 820
The FDA 21 CFR Part 820, also known as the Quality System Regulation (QSR), establishes the current Good Manufacturing Practice requirements for medical devices. 21 CFR Part 820 covers areas such as design controls, document controls, corrective and preventive actions (CAPA), and production and process controls.
21 CFR Part 820 ensures the quality and safety of medical devices produced by biotechnology companies. A 21 CFR Part 820-compliant QMS helps ensure that biotechnological medical devices are designed, manufactured, and distributed in a manner that complies with regulatory requirements and safeguards patient safety.
Medical Device Regulation (MDR)
The MDR is the Regulation (EU) 2017/745 governing medical devices in the European Union. MDR outlines the requirements related to medical device product design, manufacturing, clinical evaluation, and post-market surveillance.
MDR establishes comprehensive QMS requirements for ensuring the safety, efficacy, and performance of medical devices manufactured by biotechnology companies. Having a QMS compliant with MDR is essential for obtaining regulatory approval and marketing authorization for biotechnological medical devices in the EU. Compliance with MDR requirements and marketing authorization is demonstrated through the CE marking.
In Vitro Diagnostic Regulation (IVDR)
The IVDR is the Regulation (EU) 2017/746 establishing requirements for in vitro medical devices related to product classification, performance evaluation, conformity assessment, and post-market surveillance.
The IVDR sets forth requirements for ensuring the safety, reliability, and accuracy of in vitro diagnostic devices produced by biotechnology companies operating within the EU market. Compliance with IVDR is essential for obtaining regulatory approval and marketing authorization for biotechnological in vitro diagnostic devices.
ICH Q10
ICH Q10 is a guideline developed by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) that describes the model for a Pharmaceutical Quality System (PQS).
ICH Q10 outlines the requirements for establishing and maintaining a robust QMS throughout a drug product’s lifecycle, from development and manufacturing to commercialization. The ICH Q10 pharmaceutical quality system helps ensure the consistent quality, safety, and efficacy of biotechnological pharmaceutical products.
What Are the Primary Processes of a QMS in Biotechnology?
The primary QMS processes in the biotechnology industry are listed below.
- Document Control
- Change Control
- Training Management
- Audit Management
- Supplier Management
- Incident Management
- CAPA Management
- Equipment Management
- Product Management
The following sections provide examples of how SimplerQMS software streamlines each QMS process.
Document Control
Document control manages the creation, review, approval, distribution, and updating of documents such as standard operating procedures (SOPs), protocols, batch records, quality manuals, and others.
Document control ensures document version control, accessibility, accountability, and traceability.
In the biotechnology industry, document control is essential for ensuring consistency in processes, facilitating effective communication among stakeholders, and supporting compliance with regulatory and customer requirements.
SimplerQMS document control module provides a centralized platform for storing, managing, and controlling documents. SimplerQMS offers features such as version control, electronic signatures, and access permissions to streamline document control processes. The software also provides flexible workflows and allows for review and approval groups.
Change Control
Change control systematically manages changes to processes, procedures, documents, and others within the biotechnology industry. The change control process supports assessing the impact of changes, obtaining necessary change approvals, and documenting change implementation.
Change control ensures that any modifications to processes, procedures, and products are thoroughly evaluated and approved before implementation. Biotechnological companies utilize change control to prevent unintended change consequences, maintain product quality, and support compliance with regulatory and customer requirements.
QMS software with change management capabilities, like SimplerQMS, facilitates change control by providing predefined workflows for requesting, reviewing, and approving changes. SimplerQMS change control module automatically tracks changes in time-stamped document histories and sends notifications and reminders to relevant personnel about change control-related tasks.
Training Management
Training management involves identifying training needs, providing training, documenting training records, and evaluating training effectiveness for relevant personnel.
Effective training management ensures that personnel have the necessary knowledge and skills to perform their roles effectively. Well-trained employees contribute to the high and uniform quality and safety of biotechnological products, maintaining compliance with requirements.
eQMS software with training management features streamlines the training process. SimplerQMS training management module supports the employee training management process. The system simplifies scheduling training sessions, creating quizzes, recording training completion, and tracking training status to help ensure compliance with employee training requirements.
Audit Management
Audit management is the process of planning, conducting, reporting, and following up on internal, external, and supplier audits to assess and ensure compliance with customer and regulatory requirements.
Audit management helps identify areas for improvement, verify compliance with requirements, and ensure the effectiveness of the QMS in biotechnological processes. Audit findings may be escalated to CAPA (Corrective and Preventive Actions), which addresses issues and helps to prevent potential risks.
SimplerQMS audit management module streamlines audit management processes by providing tools for scheduling audits, assigning audit tasks, capturing audit findings, tracking audit actions, and ensuring time-stamped audit trails.
Supplier Management
Supplier management involves selecting, evaluating, qualifying, and monitoring suppliers and vendors of materials, components, and services used in biotechnological product manufacturing processes. Supplier management also involves maintaining an Approved Supplier List (ASL) to ensure that only thoroughly vetted and qualified suppliers are used by the company.
Effective supplier management ensures a reliable supply chain, mitigates supply chain risks, and maintains high and uniform product quality and regulatory compliance.
eQMS software with supplier management capabilities simplifies supplier management processes by centralizing supplier information, tracking supplier qualification statuses and performance metrics, and managing supplier documents.
With SimplerQMS, biotechnology companies streamline supplier data management. The supplier management module simplifies supplier qualification and audits, automatically sending reminders and notifications for supplier tasks as scheduled.
Incident Management
Incident management is the process of identifying, documenting, investigating, and resolving events such as deviations and nonconformances that occur during biotechnological processes.
Deviation and nonconformance management outlines the procedures for reporting incidents, conducting root cause analysis, escalating issues to the CAPA process, and documenting incident resolution.
Incident management helps prevent the recurrence of issues, improves process efficiency, and maintains high and uniform product quality and safety.
eQMS software, like SimplerQMS, streamlines incident management processes by providing tools for addressing incidents, initiating CAPA workflows, tracking incident status, and documenting investigation findings.
CAPA Management
CAPA (Corrective and Preventive Action) management is the process of identifying, investigating, addressing, and preventing deviations, nonconformances, and other issues.
CAPA management aims to improve process efficiency, product quality and safety, compliance with regulatory and customer requirements, and issue prevention. By identifying and addressing root causes, CAPA management supports continuous improvement initiatives and helps biotechnology companies mitigate risks and maintain operational excellence.
QMS software with CAPA management features provides a centralized platform for capturing incident data, assigning tasks to responsible individuals, tracking CAPA progress, and documenting investigation results.
SimplerQMS CAPA management module streamlines CAPA workflows, increases accountability, and ensures the timely completion of CAPA-related tasks. Biotechnology companies can effectively oversee every stage of the CAPA process, from root cause analysis and action planning to implementation, effectiveness checks, and closure.
Equipment Management
Equipment management refers to the systematic approach to managing equipment, encompassing activities such as regular calibration, preventive maintenance, and validation. Equipment management aims to ensure that equipment works as intended, maintains accuracy and precision, and supports compliance with customer and regulatory requirements to safeguard product quality and safety.
Effective equipment management involves proper equipment identification, calibration schedules, maintenance procedures, validation protocols, and documentation of equipment-related tasks.
An eQMS facilitates the scheduling of maintenance and calibration tasks and the management of equipment-related documentation. QMS software allows you to directly associate equipment with relevant standard operating procedures (SOPs), work instructions, and maintenance tasks.
SimplerQMS notifies relevant users about the upcoming maintenance or calibration activities to ensure they are not missed. The equipment management module centralizes all equipment records, simplifying the access and review of historical data, maintenance logs, and compliance documentation.
Product Management
Product management involves overseeing the lifecycle of a product from initial concept through product development, manufacturing, labeling, packaging, distribution, and post-market surveillance. Product management ensures that products are developed, manufactured, distributed, and managed in compliance with regulatory and customer requirements.
Product management includes activities such as product design, process validation, batch record management, quality controls, and others.
An eQMS equipped with product management features enhances the efficiency of product management by centralizing product data and facilitating collaboration across various departments.
SimplerQMS simplifies product management by organizing all product-related information. The software product management capabilities enable documents to be linked to products, lots, equipment, suppliers, and customers, allowing companies to consolidate manufacturing documents using product release notes with hyperlinks.
What Is the Role of QMS Software for a Biotechnology Company?
The role of QMS software for biotechnology companies is to streamline quality management processes.
The QMS software helps biotechnology companies ensure compliance with regulatory and customer requirements, maintain high and uniform product quality, and improve operational effectiveness.
The QMS software supports primary quality management system processes for biotechnology companies, such as document control, change control, training management, audit management, supplier management, CAPA management, and others.
SimplerQMS provides an eQMS solution specifically designed for Life Sciences, including companies operating in the biotechnology industry. QMS software that is designed for biotechnological industries helps companies achieve operational excellence, deliver safe and effective products, and comply with applicable customer and regulatory requirements.
SimplerQMS offers functionalities for quality management system processes, including robust document control capabilities to centralize and control documentation, employee training workflows to ensure personnel competence and compliance, efficient CAPA management tools to address and prevent quality issues, and more.
SimplerQMS supports all QMS processes, helping companies to comply with QMS requirements, including ISO 9001:2015, ISO 13485:2016GMP, GLP, 21 CFR Part 210, 211, and 820, MDR, IVDR, ICH Q10, and many others.
SimplerQMS is a fully validated solution according to ISPE GAMP 5. The QMS software is maintained in a validated state and receives continuous updates to align with new versions or modifications, ensuring compliance and preparedness for audits and inspections.
Discover how SimplerQMS can streamline your quality management processes and support your company. Schedule a personalized demo to speak with our expert Quality Solution Consultants.
