Quality Assurance Management Software

It’s time to take your quality assurance management to the next level. Quality Assurance Management Software can help you streamline your operations and make sure that your team is working as efficiently as possible. Whether you’re looking for something simple or complicated, there are many options available today that can fit any size business.

In this guide, we review the aspects of Quality Assurance Management Software, types of quality management systems, Why use QMS software, and What does quality management software do?

Quality Assurance Management Software

Quality Assurance Management Software is a tool that every professional who deals with quality assurance should have. It can make your job easier, and it can also help you achieve better results faster. Quality Assurance Management Software comes in two forms: cloud-based (software as a service) or on-premises software. The cloud version provides the same functionality as its on-premises counterpart, but it’s hosted by a third party rather than installed at your facility or office building. This article will explain some of the reasons why you might want to use Quality Assurance Management Software for your company’s projects—and what exactly it does for you!

Ensures data is logged and stored in a centralized location

  • Logging is an important first step of a quality assurance process. It ensures that data can be stored in a central location, such as a database.
  • Storing data in one place makes it easy to track progress, as well as identify issues with previous tests and make adjustments accordingly.

Provides multiple levels of visibility and review to ensure proper workflow management

  • Provides multiple levels of visibility and review to ensure proper workflow management
  • Proactively tracks the progress of your company’s projects, ensuring that the right people are involved at the right time in order to keep things moving smoothly.

Utilizes standard forms that seamlessly integrate with popular MS Office applications

Microsoft Office forms are a great way to get started with data collection and reporting. With the ability to customize fields for your specific needs, you can create intuitive forms for data entry, inspection, or reporting. Tracking workflows and tasks have never been easier with this feature.

The software supports two types of Microsoft Office forms: autogenerated forms and custom-created forms. Autogenerated forms are pre-built in the software platform which users can easily use by simply filling in their information without any programming knowledge needed; while custom-created forms are developed specifically according to specific needs or requirements from each user group with no limitations on functionality (you’re only limited by your imagination).

Built in workflow function for automatically routing tasks via email

With the built-in workflow function, tasks are automatically routed to the correct user and each step of the process is monitored. This ensures that nothing falls through the cracks. The system also keeps track of who has completed what task, which reduces errors by preventing multiple people from working on the same thing at once.

The workflow feature ensures that your team will complete all tasks in a timely manner—and with less effort overall!

Provides electronic sign-off on inspections and reports

This feature helps you to capture signatures on inspection and report documents. With the signature capture feature, you can:

• Record a signature of any document while capturing an image of the same document.

• Store all the captured signatures in your database for future reference.

• Use these stored signatures for legal purposes like evidence or court cases. For example, if there is an inspection that is required to be done by many people and some of them sign off on it at different times, then with this feature you can store each one of their signatures separately in your database and then use it later on when required by a court case or investigation committee etc. Such kind of stuff happens very often in industries where there are strict quality standards set up which must be followed as per law so having electronic proof/evidence becomes very important for such situations because otherwise we won’t be able to do anything about it since no one will believe us anymore if we say that our company follows certain quality standards but doesn’t have any proof except just our word (which doesn’t hold much weight nowadays).

Provides fully searchable database with user-defined queries, audit trails, filters and sorting capabilities

The software provides a fully searchable database with user-defined queries, audit trails, filters and sorting capabilities. These features allow you to quickly find the required information for an audit or assessment. The software also offers the ability to create custom reports that can be exported in various formats such as PDF or Microsoft Word documents.

Assists in the development of KPIs and metrics through fully customizable dashboards and written reports

Key performance indicators (KPIs) are a set of quantifiable measures used to track and monitor performance. KPIs can be used to evaluate both internal and external business processes, as well as an organization’s financial health. Metrics, on the other hand, measure how well your organization is performing against these metrics at any given time.

For example, let’s say you want to track the number of customers who order from your website every day. This would be considered a KPI because it allows you to see whether or not more people than usual are ordering products from your website each day. A metric would be tracking their orders by day so that you know how many products they purchased over time in order to determine which days are more profitable than others (for example).

Dashboards display KPIs in visual formats that make them easy for anyone working within an organization or project team alike to understand quickly without having too much information overload them with numbers or charts–which often happens when viewing reports written out by analysts.”

Quality Assurance Management Software can make your job easier.

Quality Assurance management software can make your job easier. It provides a centralized location for all data, giving you multiple levels of visibility and review. Standard forms are integrated into the system, so they seamlessly integrate with MS Office applications like Word, Excel, Outlook and more. Built-in workflow functionality means that tasks are routed electronically via email directly to the right person at the right time without manual intervention. Electronic sign-off on inspections and reports is completed quickly with just a few clicks of the mouse button as well!

types of quality management systems

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Types of Quality Management Systems

What Are the Different Types of Quality Management System (QMS)?

There are many different types of quality management systems (QMS) available for manufacturers looking to create a plan to improve results, track progress, and increase quality. The type of QMS you need varies depending on the industry and specific goals of your business. As with everything, you’ll want to do your research before you get started implementing a QMS. In this article, we’ll take a look at:

We’ll also help you identify which QMS type will help you drive your business forward and set realistic goals and expectations.

Methods of Quality Control and Quality Assurance

Quality is essential for a business to succeed, and there are two primary ways of managing quality – quality control and quality assurance. Quality control is the process of inspecting your products and services to ensure that industry standards and customer requirements are met. This can be done through feedback, factory inspections, and a 100% inspection system. Quality assurance involves carrying out quality checks at specific stages of the production process. This helps businesses identify faults and substandard products early on and resolves them before they go out to customers.

There are several different methods of quality control and quality assurance that businesses can incorporate into their QMS, outlined below.

PDCA (Plan-Do-Check-Act)

The Plan-Do-Check-Act is a requirement in ISO 9001, one of the most common standards used by quality management systems across a variety of industries. It is a cyclical framework that can be applied to all internal processes and helps organizations ensure that they’re delivering the highest possible quality to their consumers.

Plan

Planning is a vital part of quality control. It starts with identifying the requirements of parties interested in the QMS, which is then used to define the scope of the QMS and the QMS processes. Planning needs company leaders to be committed to driving the organization to a customer focus by defining the organizations’ roles and responsibilities and establishing a quality policy. This gives the overall QMS a fixed direction. The planning process also includes identifying and addressing potential risks, setting quality objectives, and planning for changes to support continual improvement. The final step is to implement the support structure that will allow you to carry out your plans.

Planning is a vital part of quality control. It starts with identifying the requirements of parties interested in the QMS, which is then used to define the scope of the QMS and the QMS processes. Planning needs company leaders to be committed to driving the organization to a customer focus by defining the organizations’ roles and responsibilities and establishing a quality policy. This gives the overall QMS a fixed direction. The planning process also includes identifying and addressing potential risks, setting quality objectives, and planning for changes to support continual improvement. The final step is to implement the support structure that will allow you to carry out your plans.

Do

It’s important you know how to properly execute your plan once it’s completed. Controls should be identified for quality management operations, product or service requirements need to be considered, designs developed, and controls need to be placed on any externally provided processes, services, and products. The do section involves considering all the activities of creating and providing products or services for customers and what is required to deliver maximum quality.

It’s important you know how to properly execute your plan once it’s completed. Controls should be identified for quality management operations, product or service requirements need to be considered, designs developed, and controls need to be placed on any externally provided processes, services, and products. The do section involves considering all the activities of creating and providing products or services for customers and what is required to deliver maximum quality.

Check

This involves checking the processes of the quality management system to ensure everything is functioning as planned. You should monitor, measure, analyze, and evaluate internal processes and the products and services you deliver to consumers to guarantee you are delivering the intended quality standards and customer satisfaction is being met. Internal audits are a reliable method for checking the effectiveness of the QMS. The management review process reviews and assesses all the monitored data to make changes and plans to address certain issues. The process is another successful way of analyzing the effectiveness of the system.

This involves checking the processes of the quality management system to ensure everything is functioning as planned. You should monitor, measure, analyze, and evaluate internal processes and the products and services you deliver to consumers to guarantee you are delivering the intended quality standards and customer satisfaction is being met. Internal audits are a reliable method for checking the effectiveness of the QMS. The management review process reviews and assesses all the monitored data to make changes and plans to address certain issues. The process is another successful way of analyzing the effectiveness of the system.

Act

Action involves fixing any issues found in the check step. Improving internal processes and eliminating the causes of actual or potential nonconformities are the overall goals for this step.

Action involves fixing any issues found in the check step. Improving internal processes and eliminating the causes of actual or potential nonconformities are the overall goals for this step.

Plan

This process is repeated to ensure that potential issues identified in the ‘Check’ phase or corrective actions taken in the ‘Act’ phase are incorporated into planning and meet the updated requirements in the ‘Do’ phase.

This process is repeated to ensure that potential issues identified in the ‘Check’ phase or corrective actions taken in the ‘Act’ phase are incorporated into planning and meet the updated requirements in the ‘Do’ phase.

Supply Chain Management (SCM)

Supply Chain Management is the handling of the flow of goods and services from manufacturing through to the consumer. This process is important for organizations that have a network of suppliers. Supply Chain Management is important because it plays a significant role in customer satisfaction, helping businesses deliver higher quality products and services. It can also help reduce operating costs and increase the scale of profitability.

There are six key components of Supply Chain Management:

By incorporating these six components into your organization you can provide effective Supply Chain Management and quality control.

Statistical Process Control (SPC)

Statistical Process Control (SPC) is an industry-standard methodology for measuring and controlling quality in manufacturing. Data in the form of Product or Process measurements is collected in real-time and added to a graph to pre-determine control limits. These control limits are determined by the capability of the manufacturing process and are used as an indication of normal operations. If data falls outside the control limits, this identifies that an assignable cause is likely the source of production variation, and something within the manufacturing process needs changing in order to fix the issue before defects occur.

The benefits of using SPC as a form of quality control are:

Failure Mode & Effect Analysis (FMEA)

Failure mode & effect analysis is a common analysis tool used for identifying possible failures in a design or a manufacturing or assembly process. “Failure modes” mean the ways, or modes, in which something might fail, especially if it could directly impact the customer. “Effect analysis” involves studying the consequences of those failures in order to take preventative action.

Failures are prioritized according to how serious the consequences will be, how frequently they occur, and how easily they are detected. The purpose of the FMEA is to help eliminate the risk of failures, starting with the ones that are most damaging to businesses. FMEA also documents current knowledge and actions about the risk of failure, helping businesses foster a culture of continuous improvement.

Why use QMS software

An electronic quality management system (eQMS) doesn’t just make life easier for quality teams. As the life science world gets increasingly competitive, regulated and scrutinized, the right QMS software can make the difference between success and failure.

QMS software is an investment in your life sciences company’s innovation, supporting the design of compliant products that exceed customer expectations. So how do you determine the right eQMS for you you?

Selecting an eQMS requires careful consideration – not only the features, but also the user experience, training and the platform’s ability to grow with your business.

To help your search, we’ve compiled a list of the top 5 eQMS systems available to life sciences companies in 2023.

What is an eQMS?

An eQMS is an electronic quality management platform that enables quality teams to centrally manage and monitor their compliance processes. It helps life science companies create, maintain and report on key quality data elements throughout the product lifecycle. Features like document management, training management and non-conformance tracking are just a few of the capabilities offered in an eQMS system.

Quality management software is the modern, digitized method for structuring and running a quality management system (QMS).

The primary benefit of an effective eQMS it that it assists you in automating the key, traditionally manual business processes connected to quality, compliance and product development.

In particular, businesses turn from a QMS to an eQMS to:

Choosing quality management software

Most eQMS software is designed with a particular business type, size or shape in mind. Some offer specific value for life science companies, while others are favored by food and manufacturing businesses. A global pharmaceutical brand with an extensive product portfolio will have different eQMS needs than a medical device startup focused on getting to market. 

Choosing software designed specifically for organizations like your own will translate to faster implementation, stronger adoption, and swifter time to value. For highly regulated companies in sectors like life science, choosing an eQMS comes with a lot of functionality considerations. Typical eQMS features include:

On top of this core functionality, you should consider niche features and services that could be critical to your business, such as:

Your eQMS should be targeted appropriately to your organization’s growth stage, budget, structure and industry. Choosing an eQMS that doesn’t streamline efficiently or fit your use case can lead to wasted cost, non-compliance, or costly software bloat from overly extensive configurations. 

We don’t want that to happen to you. Dive into our recommendations of the top 5 eQMS providers on the market:

5 best eQMS options

1. Qualio

Qualio is ideal for startups facing the world’s tightest regulatory requirements, from FDA and ISO demands to GxP, and is built to do 3 things especially well: 

Best for: Small- to mid-market organizations with aggressive growth goals that want an affordable eQMS system for comprehensive quality management and compliance.

Qualio is the only eQMS designed specifically for startups, small to mid-size business, and life sciences companies in the scale phase, incorporating FDA, cGMP and ISO requirements as standard for pharma, biotech and medical device manufacturers. And we’re proud of our diverse customer base stretching from America to Europe including the UK, Ireland, Sweden, Denmark, Switzerland, Norway, Belgium, Israel, Australia, New Zealand, USA and Canada.

Note: You may be thinking: this is Qualio’s website, of course they’d put themselves #1. This kind of caution and awareness of bias is important as you hunt for an eQMS vendor. To remedy bias, always look at customer reviews to see if a prospective vendor is really doing what they say they can do.

 

This eQMS is a well-known brand in the life sciences industry and among the most widely adopted eQMS systems in the vertical. Current users include several major regulatory agencies and 1,000 enterprises in 30 countries.

MasterControl’s eQMS functionality is designed to address compliance and quality management in product development, clinical trials, supplier management, regulatory risk management, manufacturing and post-market use cases.Best for: MasterControl is positioned as an enterprise eQMS for global enterprises with a large portfolio that spans the product development lifecycle. It may be right for your organization if you need a complex, highly configurable QMS software and can dedicate significant resources toward implementation and customization.Pros:

 

3. Pilgrim

SmartSolve is an eQMS software by Pilgrim, an IQVIA company that is marketed as a comprehensive solution for managing compliance, risk, quality and the supplier chain in the life sciences sector. Their QMS software is built under the ISO 9001 standard for quality management systems and provides workflows, document management, and process management.

Their quality management system software can be cloud-based or installed on-premise. Additional capabilities include features and tools for electronic signatures, audits, analytics, and validation.Best for: Enterprise organizations that can commit significant budget towards product configuration and don’t need rapid implementation of their eQMS.

According to the vendor, current clients include some of the largest enterprises in the life sciences sector. Cited industries of focus include pharma, medical devices, combination products, and blood and tissue service organizations.Pros:

 

This closed-loop software includes a full range of eQMS features for managing documents, non-conformances, 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) demands.Best for: Organizations using Salesforce or that have on-site Salesforce experts. It’s also relatively unique in support of PMDA and TGA requirements. User-provided data on software review source G2 indicates Qualityze’s customer base comprises primarily mid-sized and enterprise organizations.Pros:

 

Sparta Systems’ TrackWise product is an eQMS software platform designed for organizations subject to GMP requirements. The vendor positions the product as a comprehensive eQMS solution designed to increase visibility and improve organizational efficiency in a competitive market.

The system offers the potential to integrate into a complex software ecosystem at enterprise organizations, including real-time integration with ERP, CRM, laboratory information management (LIMS), and manufacturing execution system (MES) applications. Best for: Organizations seeking a robust solution for enterprise quality management should consider TrackWise. G2 user-reported data indicates the majority of TrackWise adopters are very large organizations. TrackWise’s potential for integration is a significant strength, but also a necessity for highly regulated businesses: the software’s features are not sufficient on their own to embed compliance with ISO 13485 and other life science standards.Pros:

 

Choosing the best eQMS 

Thanks to the growing life sciences industry, eQMS options are growing rapidly. Don’t settle for an eQMS that’s not purpose-built for your industry, exceeds your budget, or demands extensive configuration.

When it comes to finally choosing the best eQMS for you, double and triple check the key factors of user-friendliness, scalability, industry compliance and cost. Additionally, make sure you understand what type of support the system offers and how often it’s updated.

By doing your research and making an informed decision, you can make sure that you choose an eQMS system that best fits your company’s needs for the long-term.

Today, the market offers eQMS systems that are flexible, cloud-based, and more cost effective. The best eQMS for your company is the one that most closely aligns with your product and team specific goals and help you reach your next phase of growth.

What does quality management software do?

Looking to learn how a modern QMS platform can help you streamline your QMS processes? Book a free demo or learn more about how a Quality Management System (QMS) can improve quality and compliance across your organization.

Quality Management System (QMS) Definition

Quality Management System (QMS) is a formalized system that documents processes, procedures, and responsibilities for continuously delivering high-quality products and services that meet regulatory and customer requirements.

The objective of a quality management system is to provide a framework that improves communication, collaboration, and consistency across your organization while also reducing waste, and promoting continuous improvement.

As the name suggests, QMS software is a quality management platform that helps you to streamline and automate quality management processes across your organization.

The adoption of such QMS tools can help you to improve quality and compliance while also reducing operational costs. They can be used across an entire organization or within specific departments such as quality, regulatory, product development, and others.

Why is Quality Management System (QMS) Important?

The importance of a quality management system is often underestimated.

Many companies think that a quality management system is only for big businesses, but this is not the case. A quality management system can benefit any size of business in any industry.

A quality management system helps organizations drive continuous improvement, helps establish compliance with regulatory authorities, and ensures that quality is built into every aspect of the product or service. This, in turn, leads to increased customer satisfaction, loyalty, and repeat business.

Benefits of Quality Management Systems

Different Types of Quality Management Systems

There are different types of quality management systems. The right one for your organization will depend on your industry, quality requirements, and other factors.

Some common types of quality management system requirements in the context of life science industries include:

Here is an illustration of the main regulatory requirements that could be applicable to medical device pharmaceutical companies.

There are many other quality management standards applicable to organizations in other industries such as aviation, automotive, construction, etc.

To learn more about quality management systems and their requirements in different life science industries, explore the following articles:

Furthermore, non-standardized approaches to quality management may also be appropriate for certain types of organizations. These quality management approaches include:

Core Elements of a Quality Management System (QMS)

Although quality management systems can vary depending on the type of organization, there are some core elements that are common to all quality management systems.

The nine core elements of a quality management system are:

Who is Quality Management System Software For?

Quality management system software is for organizations that want to streamline and automate their quality management system, reduce quality-related costs, improve quality, and maintain compliance with quality standards.

It can be used by organizations of all sizes, in all industries, and with different quality management approaches.

QMS software enables everyone – quality control, quality assurance, regulatory affairs, product development, or any other department – to manage quality processes in a structured and consistent way.

Although not all quality management solutions are created equal. Some tools are better suited for certain types of organizations than others.

For example, at SimplerQMS, we specialize in providing quality management software for life science companies. We offer a pre-validated, all-in-one quality management solution that out-of-the-box is compliant, audit-ready, and easy to use.

What Does an Automated QMS System Do?

An automated quality management system (QMS) solution helps organizations streamline and automate quality management activities throughout the product lifecycle, from design to manufacturing, and post-market surveillance.

Automated QMS systems start by providing a centralized repository – a single source of truth for quality data. This repository can be used to manage any kind of document or file – quality control records, audits findings, customer complaints, CAPA records, etc.

Automated workflows for document creation, review, approvals, escalation, and archiving, as well as notifications and reminders, help quality teams to stay on top of their assignments.

The system automates, streamlines, and helps manage core QMS processes including:

Finally, QMS solutions provide quality reporting and analytics capabilities. These features help organizations track quality KPIs, identify quality trends, and make data-driven decisions to improve quality.

How QMS Software Can Help Your Business Today

1. Connect Data Across the Product Lifecycle

Disconnected quality data and organizational silos are common quality management challenges. Often, quality data is spread across multiple systems – from product development to manufacturing to quality assurance and customer service.

QMS platform connects quality processes and data throughout the product lifecycle. With cloud-based QMS software employees across the organization can access needed data in real-time, from anywhere. This provides a single source of truth and helps break down silos.

2. Improve Efficiency and Save Time

Organizations that rely on paper-based or hybrid quality management processes can take hours to complete quality tasks that could be done in minutes using quality management software.

Introducing a QMS platform has been shown to produce real results – including direct improvements to quality, quality-related costs, and efficiency.

One of many examples is Cortex Technology – after implementing SimplerQMS Quality Management Software they were able to decrease time on change management by more than 50%.

By automating quality processes quality teams can eliminate manual tasks, such as finding documents, making changes to records, reviews, approvals, and other tasks, reduce errors, and free up time to focus on more value-adding activities.

3. Train Employees Quickly and Effectively

Effective employee training is critical to quality and compliance. Digital quality systems with built-in training management features can help you streamline employee training by providing a central location to store training materials, employee training records, and more.

Customizable dashboards and KPI reports help monitor employee training status and performance. Plus, notifications and reminders ensure that training assignments are completed on time.

4. Streamline Core Quality Management Processes

A good QMS platform will offer a suite of quality management features to help you streamline quality processes. These would typically include:

By automating such processes, you can improve quality and compliance while reducing costs.

5. Reduce Human Error

When all quality data is manually entered it is susceptible to human error.

An automated quality management system helps to reduce human error by automating tasks such as:

As a result, quality teams can be confident that data is accurate, up-to-date, and compliant.

6. Ensure Regulatory Compliance

Modern QMS platforms help you standardize quality processes and ensure compliance with applicable quality regulations. By automating processes you can be sure that records are accurately and consistently created and that quality data is properly collected, stored, and reported.

This is especially important for quality-critical life science industries such as medical devices, pharmaceuticals, biotechnology, and others that are subject to stringent quality regulations.

SimplerQMS was purposefully built for life science industries, with regulatory compliance in mind. With pre-configured workflows for quality processes such as document control, change control, non-conformance management, CAPA management, and others, quality teams can be more confident that they are meeting quality requirements while using SimplerQMS.

Furthermore, by implementing a pre-validated QMS solution, like SimplerQMS, you will also be able to save valuable time and money on quality system validation and continuous re-validation. A requirement for quality-critical life science industries, which our quality management software already meets.

For you, the benefits of a modern eQMS solution might be obvious. But implementing it can be a big decision as it impacts a lot of people and comes with a cost, so you will need to make the case for QMS software and present it to the upper management.

What Cloud-Based QMS Offers Your Business

Nowadays, quality teams are no longer limited by on-premise quality systems.

Organizations across the globe are moving quality management systems to the cloud to take advantage of the many benefits it offers.

Ability to Work From Anywhere

Cloud-based quality management systems offer quality teams the ability to work from anywhere, all the time.

By storing files in a centralized, cloud-based location, employees can access the same information, from any device, whether they are in the office or out in the field. This is especially beneficial for quality teams that work remotely or have a distributed workforce.

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