A Quality Management System (QMS) is a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. The QMS helps manufacturing companies coordinate and direct activities to meet customer and regulatory requirements.
Several standards, regulations, and guidelines outline requirements for implementing a QMS in the manufacturing industry, such as ISO 9001:2015, ISO 13485:2016, FDA 21 CFR Part 820, ICH Q10, Good Manufacturing Practice (GMP), ISO 22716:2007, ISO 22000:2018, ISO/TS 16943:2009, AS9100D, and others.
These requirements support companies operating in manufacturing industries in developing and implementing effective QMS. Manufacturing industries encompass medical devices, pharmaceuticals, cosmetics, food and beverage, automotive, aviation, space, and defense, among other industries.
The standards, regulations, and guidelines outline requirements for essential QMS processes, such as document control, change control, training management, deviation and nonconformance management, CAPA management, audits management, supplier management, and others.
This article will cover what a QMS for manufacturing is, several QMS requirements based on different manufacturing sectors, primary QMS processes, and the role of QMS software for manufacturing companies.
SimplerQMS offers a fully validated eQMS software (according to GAMP 5) designed specifically for Life Science companies. Book a demo to see how SimplerQMS can help you streamline your quality management processes and ensure compliance.
This article covers the following topics in more detail:
- What is a Quality Management System (QMS) for Manufacturing?
- What are the Relevant QMS Requirements for Manufacturing?
- What are the Primary QMS Processes in Manufacturing?
- What is the Role of QMS Software for Manufacturing Companies?
What is a Quality Management System (QMS) for Manufacturing?
A Quality Management System (QMS) for manufacturing is a structured system of policies, processes, procedures, work instructions, and records designed to manage quality throughout the manufacturing lifecycle. Manufacturing QMS aims to ensure that products comply with regulatory and customer requirements.
The purpose of a QMS in the manufacturing industry is to ensure and enhance product quality and reliability and increase process efficiency. The manufacturing QMS helps reduce waste and increase customer satisfaction and business profitability.
Key QMS processes in manufacturing include document control, change management, training management, product management, deviation and nonconformance management, CAPA management, complaint management, audit management, supplier management, risk management, and equipment management, among others.
Traditionally, QMS processes have been managed in a paper-based format, involving manual documentation, physical storage, and in-person audits. The paper-based QMS is time-consuming, prone to errors, and challenging to maintain consistently across large companies.
In contrast, an Electronic Quality Management System (eQMS) offers a digital platform to automate and streamline the management of quality processes. An eQMS provides automated workflows, improves data integrity, facilitates accessibility, and supports compliance.
SimplerQMS provides a comprehensive eQMS solution tailored to meet the specific needs of Life Science companies. SimplerQMS is designed to streamline workflows, improve efficiency, and support compliance with stringent regulatory requirements in the Life Science industries.
Our eQMS provides integrated QMS modules for document control, product management, equipment management, CAPA management, audit management, supplier management, and much more, allowing seamless work.
What are the Relevant QMS Requirements for Manufacturing?
Manufacturing quality management systems are governed by numerous QMS requirements to ensure that products comply with regulatory and customer requirements. Strict requirements for manufacturing are essential to establish and uphold a QMS that ensures uniform and high-quality processes and products.
QMS requirements for manufacturing vary depending on factors such as industry, location, product type, and specific additional requirements.
NOTE
This section will discuss some relevant QMS requirements for manufacturing, but this is not an exhaustive list. Please always refer to the regulations, standards, and guidelines for official information.
QMS Requirements for General Manufacturing
The relevant QMS requirement applicable to general manufacturing is ISO 9001:2015.
ISO 9001:2015
ISO 9001:2015 is an international standard that specifies requirements for a quality management system. ISO 9001:2015 enables companies to demonstrate their ability to consistently provide products and services in compliance with customer and regulatory requirements.
Below are six ISO 9001:2015 sections to exemplify the requirements for QMS.
- Documented information
- Operational planning and control
- Management review
- Design and development of products and services
- Monitoring, measurement, analysis, and evaluation
- Improvement
ISO 9001:2015 helps organize a QMS, foster customer and management satisfaction, implement continuous improvement, and reduce costs.
QMS Requirements for Medical Device Manufacturing
Relevant QMS requirements that apply to medical device manufacturing are presented further.
- ISO 13485:2016
- FDA 21 CFR Part 820 (Quality System Regulation – QSR)
- European Union (EU) Regulation 2017/745 (Medical Device Regulation – MDR)
- Good Manufacturing Practice (GMP), including EU GMP, US GMP, WHO GMP, and national GMPs
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 is applicable when a company needs to demonstrate the ability to consistently comply with customer and regulatory requirements.
ISO 13485:2016 outlines specific requirements for a QMS in the design, development, production, installation, and servicing of medical devices. The ISO 13485:2016 standard focuses on the safety of the end-user and the efficacy of the medical device.
Having an ISO 13485:2015 compliant QMS helps ensure that medical device manufacturers comply with customer and regulatory requirements and improve product quality and safety.
FDA 21 CFR Part 820 (Quality System Regulation)
FDA 21 CFR Part 820, also known as the Quality System Regulation (QSR), is a regulation established by the United States Food and Drug Administration (FDA). The 21 CFR Part 820 defines the requirements for a medical device quality management system.
The 21 CFR part 820 aims to ensure the consistent production and control of medical devices, ensuring the safety and effectiveness of those products.
The 21 CFR Part 820 regulation outlines specific requirements for the design, manufacturing, packaging, labeling, storage, installation, and servicing of medical devices sold or distributed in the United States.
EU Regulation 2017/745 (Medical Device Regulation)
EU regulation 2017/745, the Medical Device Regulation (MDR), is a regulation by the European Union to ensure the safety of end-users and the efficacy of medical devices.
The EU MDR specifies the requirements for medical device design, manufacture, clinical performance, post-market surveillance, and more across EU member states. Having an MDR-compliant quality management system helps ensure compliance with the requirements for medical device manufacturing, improving product safety and quality while reducing the risk of non-compliance.
The MDR Article 10 outlines the general obligations of QMS manufacturers in the medical device industry, including product realization, reporting of serious incidents, and risk management, among others.
Good Manufacturing Practice (GMP) for Medical Device Manufacturing
Good Manufacturing Practices (GMP) are regulations, standards, and guidelines designed to ensure the uniform and high-quality production and control of products.
GMPs are established by various governments and organizations, such as the European Union and the World Health Organization (WHO). Fortunately, these GMP standards are highly similar.
GMP covers various aspects of manufacturing, including cleanliness, equipment verification, process validation, and documentation. A QMS must meet GMP requirements to enable companies to achieve and maintain product quality and safety.
Examples of GMP standards include US GMP, EU GMP, and WHO GMP, among others.
US GMP for Medical Device Manufacturing
US GMP stands for the United States Good Manufacturing Practice.
The US GMP refers to the requirements set by the FDA to ensure the quality, safety, and efficacy of medical devices, pharmaceuticals, biologics, food, and cosmetics manufactured in the United States.
The FDA outlines specific QMS requirements for medical device manufacturers under 21 CFR Part 820. The 21 CFR Part 820 regulation sets forth the Current Good Manufacturing Practice (CGMP) requirements for medical devices.
EU GMP for Medical Device Manufacturing
EU GMP stands for European Union Good Manufacturing Practice. The EU GMP guideline helps ensure the quality and safety of medicinal products, medical devices, food, and cosmetics.
In the European Union, medical device manufacturers are required to comply with EU GMP under the MDR. These GMP requirements ensure the production of medical devices with high and uniform safety and quality.
Compliance with the MDR and obtaining CE Marking are essential for manufacturers to market and sell medical devices across the 30 countries within the European Economic Area (EEA).
WHO GMP for Medical Device Manufacturing
The WHO GMP are the GMP requirements set forth by the World Health Organization (WHO). The WHO GMP helps ensure products are consistently produced and controlled in compliance with quality standards appropriate to their intended use.
WHO GMP outlines requirements that are broadly applicable to various medical products, including medical devices and pharmaceuticals. The WHO GMP specifies requirements for everything that directly or indirectly affects the product’s safety and quality, including personnel, materials, premises, and methods.
Other National GMPs for Medical Device Manufacturing
Various countries have their own GMP requirements. National GMP often aligns with international standards but may have additional specific regulations and guidelines.
Manufacturers exporting to different countries must comply with the respective GMPs.
QMS Requirements for Pharmaceutical Manufacturing
Relevant QMS requirements that apply to pharmaceutical manufacturing are presented below.
- ICH Q10
- PIC/S GMP
- Good Manufacturing Practice (GMP), including EU GMP, US GMP, WHO GMP, and others.
ICH Q10
ICH Q10 is a guideline by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). The ICH Q10 guideline describes a model for an effective quality management system for the pharmaceutical industry, referred to as the Pharmaceutical Quality System (PQS).
The ICH Q10 provides a comprehensive framework for establishing and maintaining the PQS throughout the product lifecycle. ICH Q10 aims to enhance the quality and availability of medicines worldwide in the interest of public health.
Implementing the ICH Q10 pharmaceutical quality system across the product lifecycle encourages innovation and continuous improvement and strengthens the link between pharmaceutical development and manufacturing processes.
PIC/S GMP
The PIC/S GMP is the GMP guideline developed by the Pharmaceutical Inspection Co-operation Scheme (PIC/S) for medicinal products.
PIC/S GMP is designed to promote harmonized standards for the quality assurance of medicinal products in the pharmaceutical industry worldwide.
The PIC/S GMP is similar to ICH Q10 and EU GMP in various aspects of pharmaceutical manufacturing. All these requirements aim to ensure that medicinal products are consistently produced and controlled in compliance with the appropriate requirements for their intended use.
Good Manufacturing Practice (GMP) for Pharmaceutical Manufacturing
Good manufacturing practices for pharmaceutical manufacturing are the regulations, standards, and guidelines that ensure the quality, safety, and efficacy of medicinal products.
These requirements ensure the consistent production and control of pharmaceutical products to comply with quality standards appropriate for their intended use.
Pharmaceutical manufacturing GMPs are enforced by regulatory agencies such as the US FDA and the European Medicines Agency (EMA).
US GMP for Pharmaceutical Manufacturing
The US GMP for pharmaceutical manufacturing is outlined in the FDA 21 CFR Part 210 and FDA 21 CFR Part 211 regulations.
FDA 21 CFR Part 210 specifies the minimum Current Good Manufacturing Practices (CGMP) for manufacturing, processing, packing, or holding of drugs. The 21 CFR Part 210 aims to ensure that drug products are safe, have identity and strength, and meet the indicated quality and purity characteristics.
FDA 21 CFR Part 211 provides more specific CGMP requirements for the production of finished pharmaceuticals. The 21 CFR Part 211 outlines the requirements necessary to ensure the quality, purity, strength, and identity of finished drug products.
The 21 CFR Part 211 covers principles applicable to the pharmaceutical industry, including several requirements related to the following areas.
- Personnel
- Buildings and facilities
- Equipment
- Control of components
- Drug product containers and closures
- Production and process controls
- Laboratory controls
- Records and reports
- Handling of complaints
- And more.
EU GMP for Pharmaceutical Manufacturing
The EU GMP guideline outlines the rules governing medicinal products in the EudraLex Volume 4.
EU GMP provides basic requirements for the manufacture of medicinal products for human and veterinary use, in addition to several specific annexes. EU GMP serves as a comprehensive resource to help pharmaceutical manufacturers maintain uniform and high quality throughout the production process.
EudraLex Volume 4 specifies the requirements for various aspects of pharmaceutical manufacturing, including facilities, equipment, personnel, documentation, quality control, distribution, and more.
Pharmaceutical companies operating within the EU or seeking to market their products in EU member states must comply with the requirements outlined in EudraLex Volume 4.
WHO GMP for Pharmaceutical Manufacturing
The WHO GMP aims to ensure that pharmaceutical products are made consistently and controlled according to suitable quality standards for their intended use and as needed for marketing approval.
GMP focuses on reducing risks in pharmaceutical production, especially related to preventing mix-ups between different products and ensuring accurate labeling.
WHO GMP also provides a foundation for creating national guidelines for GMP for biological products.
Other National GMPs for Pharmaceutical Manufacturing
Different countries have specific GMP requirements. National GMP can follow international requirements and also include specific national rules and recommendations.
Pharmaceutical manufacturers exporting to different countries must comply with the corresponding GMP requirements.
QMS Requirements for Cosmetics Manufacturing
Relevant QMS requirements that apply to cosmetics manufacturing are ISO 22716:2007 and Regulation (EC) 1223/2009 (EU Cosmetics Regulation).
ISO 22716:2007
ISO 22716:2007 standard outlines the requirements for the manufacturing processes of cosmetics. ISO 22716:2007 helps ensure cosmetic production, control, storage, and shipment.
ISO22716:2007 establishes a framework for implementing GMP guidelines to define the activities that enable companies to obtain a product that meets defined characteristics.
Regulation (EC) 1223/2009 (EU Cosmetics Regulation)
The Regulation (EC) No 1223/2009, also known as the EU Cosmetics Regulation, establishes the requirements within the European Union governing the safety, production, and labeling of cosmetic items.
The EU cosmetics regulation specifies that products must undergo rigorous testing to ensure their safety for human use under expected conditions. Companies must ensure their cosmetics comply with the EU cosmetics regulation requirements before they can be sold in the EEA market.
QMS Requirements for Food and Beverage Manufacturing
Relevant QMS requirements that apply to food and beverage manufacturing are the Global Food Safety Initiative (GFSI) and ISO 22000:2018.
The Global Food Safety Initiative (GFSI)
The Global Food Safety Initiative (GFSI) is a collaboration between various stakeholders in the food industry, including retailers, manufacturers, food service companies, and others. The GFSI helps ensure food safety standards for businesses and provides people with access to safe food.
The GFSI operates as a benchmarking organization that sets criteria for food safety management systems, which are recognized globally. GFSI approves several food safety standards covering farming, packaging, storage, and distribution.
GFSI outlines several principles and requirements related to food safety across the supply chain. GFSI includes requirements for personal hygiene and operational practices similar to GMPs. Hazard analysis and critical control points (HACCP) principles are also included in GFSI requirements, which help identify and control food safety skills.
GFSI encourages continuous improvement, improves food safety and customer loyalty, and supports regulatory compliance.
ISO 22000:2018
ISO 22000:2018 is an international standard that specifies requirements for food safety management. ISO 22000:2018 standard aims to support companies involved in the food chain to plan, implement, operate, maintain, and update a Food Safety Management System (FSMS).
ISO 22000:2018 outlines elements that must be included in an effective FSMS, for example:
- Interactive communication across the company.
- Documentation to be included in the management system.
- HACCP principles that help identify, prevent, and remove food safety hazards.
QMS Requirements for Automotive Manufacturing
The relevant QMS requirement applicable to automotive manufacturing is IATF 16949:2016.
IATF 16949:2016
IATF 16949:2016 is an international standard that outlines the QMS requirements for the design, development, production, installation, and service of automotive-related products.
IATF 16949:2016 standard focuses on continuous improvement, defect prevention, and reduction of variation and waste in the supply chain. The IATF 16949:2016 shares similarities with ISO 9001:2015 in terms of QMS core principles and structure.
IATF 16949 standard includes additional automotive-specific requirements tailored to the unique needs and challenges of the automotive industry, such as control of repaired products, automotive product-related software, and engineering specifications.
QMS Requirements for Aviation, Space, and Defense Manufacturing
Relevant QMS requirements that apply to aviation, space, and defense manufacturing are the AS9100, AS9110, and AS9120.
AS9100
AS9100 is an internationally recognized quality management standard for the aerospace industry. AS9100 specifies requirements for establishing, implementing, and maintaining a quality management system to ensure the consistency and quality of aerospace products and services.
AS9100 applies to all aerospace organizations, from design and manufacturing to maintenance and stockist distributors.
AS9100 incorporates all the ISO 9001:2015 requirements and supplements them with additional criteria tailored to the aviation, space, and defense sectors, such as counterfeit parts prevention and reporting.
AS9110 and AS9120
AS9110 and AS9120 are quality management system standards for aerospace maintenance companies and aerospace distributors, respectively.
These standards outline specific requirements for companies involved in maintenance, repair, and overhaul activities and aerospace parts distribution.
What are the Primary QMS Processes in Manufacturing?
The primary quality management system processes in manufacturing are listed below. This article focuses on manufacturing, so the design and development process is not included.
- Document Control
- Change Control
- Training Management
- Deviation and Nonconformance Management
- CAPA Management
- Complaint Management
- Audit Management
- Supplier Management
- Risk Management
- Equipment Management
- Product Management
Examples of how SimplerQMS software can streamline each QMS process will be provided.
Document Control
Document control encompasses creating, reviewing, approving, storing, distributing, and revising documents within the quality system.
The document control process maintains the integrity of manufacturing operations and helps achieve compliance with regulatory and customer requirements. Effective document control prevents errors and inconsistencies in product quality by ensuring all personnel access up-to-date and accurate documents.
An eQMS with robust document control capabilities, like SimplerQMS, streamlines the document control process. The eQMS facilitates control of document versions, easy access to currently in-use documents, and the secure storage and retrieval of in-use and obsolete documents.
Automated notifications related to document release, review, and approval activities reduce time and effort in document creation and approval cycles. Additionally, eQMS solutions provide capabilities for electronic signatures, time-stamped audit trails, and controlled printing.
Change Control
Change control is the process of managing all changes within manufacturing companies related to processes, procedures, products, documents, templates, and others. Change control involves evaluating, approving, implementing, and monitoring changes to ensure they are controlled and documented.
Change control prevents disruptions and defects that arise from uncontrolled changes, ensuring that any modification is thoroughly assessed.
Electronic QMS, such as SimplerQMS, provides capabilities to streamline the change control process. The eQMS automates the workflow of change requests, from initiation through review, approval, implementation, and effectiveness assessment.
SimplerQMS change control module facilitates monitoring change status and related documentation updates with automatic notifications and task reminders. The eQMS software enables real-time collaboration across departments, ensuring all employees participate in the change management process.
Training Management
Training management is the process of managing employee training and development programs, from initial planning and resource coordination to execution and evaluation. A well-established training management process ensures that the workforce possesses the necessary skills and knowledge to perform their tasks.
Training management ensures that employees are aware of their roles and responsibilities within the company. Effective training programs contribute to risk mitigation and foster a culture of continuous improvement by empowering employees with the knowledge necessary to manage risks.
The eQMS streamlines training management, automating tasks such as assigning training activities, sending email notifications, conducting training effectiveness assessments, and tracking training progress.
The training management capabilities in SimplerQMS can enhance scheduling, tracking, and follow-up of training gaps and missed deadlines, eliminating delays for employees to acquire applicable knowledge.
Deviation and Nonconformance Management
Deviation and nonconformance are events within a process or procedure in which the result does not comply with the established requirements.
Inefficient management of deviations and nonconformance can result in non-compliance with internal policies, procedures, or regulatory and customer requirements. A well-structured deviation and nonconformance management process helps companies identify the root cause of issues and prevent potential problems in product or service quality.
Quality management software streamlines the management of deviations and nonconformance management, facilitating timely investigation and resolution. With eQMS solutions, like SimplerQMS, companies efficiently manage the entire lifecycle of a deviation or nonconformance, from initial detection through to closure and effectiveness assessment.
The features an eQMS provides in the context of nonconformance and deviation management include automated workflows for recording, reviewing, and closing deviations and nonconformances. QMS software integrates with other connected QMS processes, such as CAPA (Corrective and Preventive Actions), to ensure comprehensive issue resolution.
CAPA Management
CAPA (Corrective and Preventive Action) management is a process aimed at preventing issues, such as deviations and nonconformances, from occurring. CAPA process identifies and addresses the root cause of issues by systematically investigating discrepancies in procedures and products.
Companies implement corrective actions to address current issues and preventive actions to prevent the recurrence of similar issues.
The CAPA process typically comprises several key steps: identification, evaluation, investigation, analysis, action plan, implementation, and follow-up.
Implementing QMS software with CAPA management capabilities streamlines the entire CAPA process, from identifying issues to resolving and closing them. The eQMS automates workflows, improves accountability, and helps ensure CAPA-related tasks are completed on time.
With an eQMS, like SimplerQMS, companies can efficiently manage all steps of the CAPA process, including root cause analysis, action planning, action implementation, effectiveness checks, and closures.
Complaint Management
A complaint is an expression of dissatisfaction made by a customer to a company regarding its product or service. Complaint management involves the systematic handling, investigation, and resolution of customer complaints.
Customer complaint management is essential for companies due to the impact on product quality, safety, and customer trust. Complaint management is a diagnostic tool to identify and rectify underlying issues, with each complaint acting as a symptom.
Implementing eQMS with complaint management capabilities facilitates the efficient recording, tracking, and resolution of complaints. With the SimplerQMS complaint management module, companies can automate task assignments, track complaint progress, and maintain a centralized repository of complaint records and related documentation.
The software enables easy linkage of complaints to specific products and lot numbers and integration with other modules, such as CAPA, facilitating comprehensive issue resolution and continuous improvement.
Audit Management
Audit management is a systematic process that manages all activities related to auditing, from planning and scheduling to conducting and documenting audit findings. Audits assess the effectiveness of the QMS and compliance with regulatory and customer requirements and help identify areas for improvement.
With regular audits, companies verify compliance with internal and external requirements, identifying gaps in quality management practices. Audit findings can lead to corrective and preventive actions, mitigating potential risks.
An eQMS facilitates the scheduling and planning of audits (regulatory, supplier, internal), the assignment of auditors, and the tracking of audit findings and recommendations.
SimplerQMS audit management module streamlines the creation of audit checklists, allows the compilation of audit findings electronically, and manages follow-up activities more efficiently. The eQMS ensures that audit records are securely stored and easily accessible for review and analysis.
Supplier Management
Supplier management involves selecting, evaluating, and monitoring suppliers to ensure they comply with relevant regulatory and customer requirements.
Effective supplier management ensures that materials and components sourced from suppliers meet quality specifications, reducing the risk of product failures, recalls, and non-compliance issues. The supplier management process also ensures strong supplier relationships and supply chain continuity and supports the company’s overall quality objectives.
eQMS software streamlines supplier qualification processes and the handling of supplier-related documentation, including contracts, quality agreements, and required certificates.
Through SimplerQMS, companies can consolidate supplier data, simplifying the process of evaluations and audits. The supplier management module automatically notifies about re-evaluations or necessary follow-up actions according to a set schedule, helping ensure compliance and quality assurance.
Risk Management
Risk management is a systematic process of identifying, assessing, prioritizing, and mitigating risks that can affect product quality and safety. Risk management involves analyzing issues, evaluating potential impacts, and developing strategies to manage or minimize adverse effects.
The risk management process typically comprises five essential steps.
- Risk Identification
- Risk Assessment
- Risk Control
- Risk Review
- Risk Communication
Risk management is essential in highly regulated industries to ensure products and services maintain compliance with regulatory and customer requirements. By identifying and assessing quality risks early on, measures can be taken to prevent or mitigate risks.
eQMS with risk management capabilities facilitates the systematic documentation, analysis, and reporting of risks.
SimplerQMS risk management module provides automated workflows to ensure that risk-related tasks are promptly addressed. Notification and reminders ensure decision-makers are informed of significant risk changes. The eQMS offers the capability to link risk-related documents to related processes, documents, and CAPAs, providing a comprehensive view of risk management activities.
Equipment Management
Equipment management is the process of managing all aspects of a manufacturing facility’s equipment. Equipment management ensures that equipment is calibrated, maintained, and operated in a manner that supports product quality, safety, and compliance.
Equipment management includes scheduling regular maintenance, calibration, validation, and ensuring that equipment operates within specified parameters.
Properly managed equipment reduces the risk of production downtime, product quality issues, and non-compliance with regulatory and customer requirements.
eQMS allows the scheduling of maintenance and calibration activities, tracks the history of equipment performance, and manages documentation related to equipment validation and operation procedures. Equipment can be directly linked to specific standard operating procedures (SOPs), work instructions, and maintenance tasks.
SimplerQMS offers notifications for upcoming maintenance or calibration tasks, ensuring these critical activities are not overlooked. The equipment management module also allows for the centralization of equipment records, making it easier to access and review historical data, maintenance logs, and compliance documents.
Product Management
Product management is the systematic process of managing a product’s lifecycle, from design to manufacturing. Product management helps ensure products are safe and comply with customer and regulatory requirements.
Product management involves tasks such as product design, development, production scheduling, manufacturing, and quality control.
An eQMS with product management capabilities streamlines product management processes by centralizing product data, enabling effective collaboration across departments, and tracking product manufacturing stages.
SimplerQMS offers product management capabilities by streamlining the organization of product-related information. The QMS software allows the relation of documents to products, product lots, equipment, suppliers, customers, documents, and more. Companies can use product release notes to consolidate documents related to the manufacturing process and products through hyperlinks.
What is the Role of QMS Software for Manufacturing Companies?
The eQMS software for manufacturing companies streamlines and improves quality management processes.
eQMS software centralizes and automates the management of quality processes, supports compliance with regulatory requirements, improves efficiency, and helps maintain product safety and quality.
QMS software allows the management of QMS processes, including document control, change management, CAPA management, training management, audit management, supplier management, risk management, and equipment management, among others.
A key capability of QMS software is the integration with other software applications, such as ERP (Enterprise Resource Planning), MES (Manufacturing Execution System), PLM (Product Lifecycle Management), SCM (Supply Chain Management) systems, and more.
SimplerQMS is a ready-to-use eQMS tailored specifically for Life Sciences companies, including pharmaceutical, medical devices, biotechnology, laboratories, CROs, and CMOs. SimplerQMS streamlines all QMS processes with automated workflows and interlinked documents, ensuring seamless and efficient workflow.
SimplerQMS’ comprehensive support of QMS processes helps companies to comply with various QMS requirements in the Life Sciences industry, including ISO 9001:2015, ISO 13485:2016, FDA 21 CFR Part 820, GMP, EU MDR, ICH Q10, among others.
SimplerQMS is fully validated according to ISPE GAMP5. The system is kept in a validated state, with continuous updates whenever new versions or changes are introduced, ensuring compliance and readiness for audits and inspections.
Experience how SimplerQMS streamlines QMS processes and supports your Life Science company’s needs. Book a demo and speak with our Quality Solution Consultants experts.
