The 6 Best QMS Software Solutions for Life Sciences
QMS is a foundation for your life science organization, so it’s critical to choose the best QMS software to ensure your success. To make your evaluation easier, we’ve compiled a list of the best QMS software solutions for life sciences on the market today.
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Best Quality Management Software Comparison
To choose the six best QMS software platforms for organizations operating in the life science industries (be it in a medical device, biotech, or pharmaceutical industry), we looked at their business websites and used our extensive knowledge about the industry and its players. We also asked our customers and partners about other QMS solutions as well as read reviews to better understand their needs. Below we compare QMS software by SimplerQMS with other QMS platforms and explain which one is better for certain needs.
What is QMS Software?
QMS software is a computer application that helps organizations manage their Quality Management System (QMS). It provides a central repository for all quality-related documentation, making it easier to track and manage quality processes. Quality management software streamlines and automates quality management processes such as audit management, document control, change control, complaint management, quality event management, CAPA management, employee training, and others.
Why Should Life Science Businesses Use QMS Software?
QMS software is essential for any organization that wants to improve its quality management system. Especially in life science, where quality is critical to patient safety and product efficacy, such software provides a much-needed layer that helps to increase efficiency, reduce costs, improve quality, and ensure compliance with quality standards.
Traditionally, quality management systems were manual, paper-based processes that were time-consuming and often resulted in errors. QMS solution automates and streamlines quality management processes, making it easier to track and manage quality data, identify trends and issues, and take corrective action when necessary.
In addition, QMS software provides real-time visibility into quality data, which is essential for making informed decisions about quality improvement initiatives. It also allows life science organizations to easily share quality data with regulatory agencies and other stakeholders.
The reasons why life science businesses need to use quality management system software are evident.
But with so many QMS solutions on the market, how do you choose the right one for your organization? To help you choose the best QMS software for your organization’s needs, we’ve compiled a list of the six best QMS software solutions for life science organizations. Additionally you can use our free QMS Software Comparison Template when you are in the process of talking to potential software vendors and comparing the top software solutions side-by-side. If you haven’t decided on moving on to an electronic QMS yet or have difficulties convincing management that it’s the right decision, we recommend you download our free QMS Software Business Case Template to calculate the economic benefits of going electronic.
What Are the Benefits of a QMS Software?
A typical quality management software benefits life science organizations in the following ways.
Streamlined quality processes. Standardize and streamline quality processes across an organization. For example, ensure that all employees are following the same quality procedures, that employees get the most up-to-date training information, that quality data is properly collected, and much more.
Improved efficiency. Reduce the amount of time and resources needed to manage quality processes. Sign documents using electronic signatures, automate document version control, store quality data in a central repository, cross-reference documents to processes, suppliers, equipment, standards, etc., and quickly find the most recent versions of documents.
Improved quality and customer satisfaction. By streamlining quality processes and improving efficiency, a QMS can help improve the overall quality of products and services, as well as customer satisfaction.
Reduced costs. By improving efficiency and quality, you can reduce costs associated with quality management. For example, you may be able to reduce the number of errors in production, such as rework and scrap, save significant time and cost on employee training, and reduce the time needed to resolve quality issues.
Regulatory compliance. Ensure that the organization has the necessary processes and procedures in place to meet these requirements, and reduce time spent on compliance-related activities.
Integrated quality processes. Easily connect QMS processes such as document management, training management, corrective and preventive action (CAPA), customer complaints, audits, and more. This allows for a more holistic view of quality management, eases search and retrieve of documents i.e. for audits, and helps identify areas for improvement.
Improved collaboration. With a lot of people working from home and remotely nowadays, being able to co-author documents at the same time and making it possible to read and sign documents no matter where you are, increases flexibility and efficiency.
Real-time visibility into quality data. Gain insights into quality data with reporting and analytics tools and make better-informed decisions about where to focus quality improvement efforts.
What Other Criteria You Should Consider When Choosing an eQMS?
When you’re considering which quality management software (QMS) platform is best for your life science organization, there are several key criteria and features you should look for.
QMS process coverage. The first thing you should look for is a QMS platform that supports QMS processes relevant to your organization, hence it is important to reflect on your organization’s current needs and pain points, but also consider future needs in a growing business. This could include processes such as document control, training management, supplier management, audit management, non-conformance and deviation management, CAPA management, and more.
Out-of-the-box workflows. Another important criterion is whether the platform comes with out-of-the-box workflows for various QMS processes such as change requests, issue recording, CAPA management, audit management, and others. This will save you a lot of time and effort in setting up and configuring the software.
User interface. The user interface is important for both the ease of use of the software as well as its adoption within the organization. A simple and straightforward user interface will help users quickly learn and adopt the software. For example, consider whether the software is based on familiar Microsoft Office applications or employees will need to learn a new interface and document editor.
Flexibility and customization. Even if a platform comes with out-of-the-box workflows, you will still need some degree of flexibility and customization to fit the specific needs of your organization. So, look for a platform that is customizable enough to suit your specific needs.
Ability to integrate with other software. A QMS platform should be able to integrate with other software used in your organization, such as your Enterprise Resource Planning (ERP) System, Product Lifecycle Management (PLM) Software, Learning Management System (LMS), and more. This will allow for a seamless flow of data between different software systems and avoid the need to manually enter data in multiple systems.
Computer system validation. You will need to consider whether 1) the quality management system software is pre-validated and 2) how you manage to keep the software validated when changed and updated. Some vendors offer computer system validation services at a hefty cost or expect the organization to validate the system while others guarantee a continuous validated system. This is important if you are subject to regulatory requirements such as 21 CFR Part 11 and ISO 13485:2016.
Hosting options. You should also consider whether a QMS software provider offers on-premise or cloud-based hosting options. These days, more and more organizations are moving to the cloud, due to its many advantages such as lower upfront costs, easier scalability, and increased security. So, it is worth considering a platform that offers this option.
Regulatory compliance with applicable requirements. As a life science organization, you are subject to various regulatory requirements such as 21 CFR Part 11 electronic signature requirements, GMP, ISO 13485:2016, and others. So, it is important to choose a QMS platform that can help you meet these requirements.
Partnering and life-science experience. When selecting an organization critical system such as QMS software, you must do due diligence to ensure that the provider can be considered a trusted partner that understands your processes, needs, and pain points. Selecting a vendor specialized in Life Sciences would often be the best choice. Ask for a presentation of existing customers within your own area of specialty (i.e Medical Devices, Pharmaceuticals, CDMO, IVD, Laboratory, SaMD, etc).
Implementation and support. Make sure that the provider offers professional services to help you with the implementation as well as training for your staff and ongoing support after the implementation. Clarify what is included in the implementation services, how long the implementation will take, and whether implementation is included in the price of the software or is offered at an additional cost. Also, ask about the support options and make sure that there is a support team available when you need them, and consider researching online reviews of the provider’s support team.
License types. Make sure to find out about the various license types offered by a QMS software vendor. Ensure that the license types offer the flexibility you need in terms of the number of users, features, and functionality. Multi-user licenses (also called concurrent licenses) are for example not offered by all vendors but can prove very valuable from a cost perspective. If you have 10 R&D people who need to edit documents now and then but are not heavy users – then you may need to pay full price for named/full licenses instead having 1-2 multiuser licenses.
Pricing. Of course, you will also need to consider the cost of the software. But, beware of choosing a platform solely on price. Be sure to consider all of the other factors mentioned above to ensure that you are getting a platform that is fit for your purpose now and in the future – and offers good value for money.
Use our QMS software comparison template to compare your shortlisted QMS software platforms against each other and choose the best one for your organization. Or use the template as an inspiration to create your own quality management software requirements list.
SimplerQMS
Deployment: Web, iOS, Android, Windows
Quality management software by SimplerQMS (that’s us!) is pre-validated, cloud-based, and specifically designed for organizations within the Life Science industries.
The software provides automated workflows for processes such as document authoring, review, escalation, reminders, notifications, approval, archiving, and more, allowing you to save time and work more efficiently. Native integration with Microsoft Office applications such as Word, Excel, and PowerPoint, allows multiple users to work on the same documents without leaving SimplerQMS. In addition, an open API allows for any type of integration you may need, as well as automatic batch record importing.
Thanks to unmatched QMS process support, available in all plans, you can be confident that SimplerQMS will help you meet your quality and compliance goals – whether it’s streamlining document control, preparing for an audit, managing suppliers, employee training, non-conformances, customer complaints, CAPAs or other areas. SimplerQMS aligns with the latest regulatory requirements such as FDA 21 CFR Part 11, Annex 11, ISO 13485:2016, FDA 21 CFR Part 820, GxP, and more.
What’s more, our software is backed by experts in quality management and computer system validation, we ensure continuous re-validation, and provide audit assistance, so you can be confident that we will help you meet your quality and compliance goals – now and in the future.
SimplerQMS is offered as an annual subscription with pricing based on the number of user licenses (incl. multi-user/concurrent license types). Everything is included in the subscription price – implementation, training/onboarding, validation, continuous re-validation, hosting, audit assistance, all QMS modules, and more.
Considerations about working with SimplerQMS:
SimplerQMS is pre-validated and allows for configuration within a validated framework based on the regulatory requirements of GxP, ISO13485, etc.
You can therefore get started quickly and avoid spending time defining processes from scratch. You will also avoid time-consuming and complex activities for the validation and re-validation of the software.
If you are looking for a custom-developed eQMS which needs to be validated before use by your organization, then SimplerQMS is most likely not the right choice for you.
SimplerQMS is integrated with Microsoft Office and live editing of documents is done directly in Word, Excel, etc., while changes and a full audit trail are automatically saved in the cloud. If you prefer not to use Microsoft Office for working with your documentation, then SimplerQMS is probably not the right choice for your organization.
Qualio
Deployment: Web
Also purpose-built, cloud-based quality management software for the Life Science industry, Qualio comes with key features like document authoring, review, and approval, collaboration, staff training, and full audit trails.
With Qualio, you can create controlled documents and records, as well as review and comment on documents inside their web-based document editor, in a collaborative environment. It helps you manage and streamline document control, training, non-conformances, complaints, CAPAs, and suppliers and offers some flexibility in process workflow customization.
Qualio’s QMS software solution complies with the latest regulations and standards such as 21 CFR Part 11, ISO 13485, 21 CFR Part 820, and ISO 14971.
It integrates with the most popular apps such as Google Suite, Asana, Jira, Azure DevOps, TestRail, and others, so you can work with the tools you’re already familiar with. Although, it does not integrate with Microsoft Office document editing applications.
Its simple and powerful reporting makes it easy to see what’s happening in real time.
Furthermore, Qualio+ add one provides you access to a partner network of quality and regulatory experts who can provide you with the support you might need in different stages of your quality journey. Whether you’re looking to implement a QMS, want to improve your existing quality system, or want help with audit preparation.
Qualio offers annual subscription plans with pricing based on the type of plan and the number of users (No multi-user licenses available though).
Considerations about working with Qualio:
Qualio has its own built-in editor, which does not rely on Microsoft Office. Therefore, Qualio might be a better choice for you if you prefer not to use Microsoft Office for editing documents.
Customers need to purchase onboarding services separately and perform PQ validation themselves.
MasterControl
Deployment: Web, iOS, Android, Windows
MasterControl is one of the most well-known quality management software systems on the market. It’s a comprehensive, scalable solution that covers all aspects of quality and compliance for life science and other highly-regulated companies.
From document control, supplier management, product development, and manufacturing to audits, training, clinical trials, CAPA, regulatory risk management, and other QMS processes, MasterControl has it all. With MasterControl, organizations can streamline compliance with FDA regulations, and ISO standards while reducing costs, increasing efficiency, and maintaining quality.
As with most QMS software providers, pricing for MasterControl’s QMS software solution is subscription-based and depends on the number of users, selected modules, and application functionality. MasterControl only offers named user licensing (with full or view-only access), which means that each person who needs to access the system must have their own individual login.
Validation is included in the subscription package and includes complete software validation documentation, their patented Validation Excellence Tool (VxT)™ which uses a risk-based approach to tailor validation to your organization’s needs, and a validation expert’s guidance for the initial validation. Thereafter, it is the customer’s responsibility to perform continuous system validation.
Considerations about working with MasterControl:
MasterControl is positioned as an enterprise-level solution and is used by some of the largest companies in the world. Therefore, it might not be the best fit for small to mid-sized organizations.
MasterControl has a very extensive set of features, which is typically suited for larger organizations with complex needs. If your organization has complex needs and can pay for software that comes with a higher price tag, then MasterControl could be the right choice for you.
TrackWise
Deployment: Web, iOS, Android, Windows
Sparta System provides two QMS software solutions – TrackWise and TrackWise Digital.
TrackWise is the world’s leading on-premise enterprise quality management software system, which offers several industry best-practice workflows that are pre-configured that can also be adaptable and configurable to meet an organization’s specific needs. The system helps automate and streamline core quality processes including, but not limited to, document control, change control, CAPA management, audits, training management, supplier quality management, and complaint management.
TrackWise Digital is Sparta Systems’ cloud-based quality management software solution with integrated modules that help support quality and regulatory compliance processes for life science and other highly-regulated organizations. TrackWise Digital is powered by the Salesforce platform and offers a flexible and scalable cloud-based solution to meet the needs of growing organizations. And similar to the legacy TrackWise on-premise solution, it includes all of the core quality management modules for managing quality, complaints, documents, training, supplier quality management, and more. The system offers powerful reporting and analytics capabilities to help identify trends and areas for improvement across all quality processes.
With QualityWise.ai, TrackWise Digital utilizes machine learning and natural language processing to automatically categorize and correlate complaints and quality events, allowing for greater productivity and intelligent decision-making throughout the company. Furthermore, the system can be integrated with other enterprise applications such as CRM, ERP, LIMS, and MES systems.
By choosing TrackWise Digital instead of the on-premise TrackWise solution, organizations can take advantage of the benefits of cloud-based quality management software, such as anytime, anywhere access and reduced IT infrastructure costs.
Pricing information is not readily available on the Sparta Systems website. To get a quote, you need to contact the sales team directly. But it does appear that the pricing of TrackWise depends on the number of user licenses, selected quality processes, as well as implementation needs.
Considerations about working with TrackWise:
TrackWise is marketed as an enterprise-level quality management software solution, so similar to MasterControl, it might not be the best-suited solution for small to mid-sized organizations.
TrackWise offers a high level of customization and many complex options for organizations that have very specific requirements in the documentation processes. If this is the case in your organization and you have the required budget available, then Trackwise might be a good choice for you.
Q-Pulse
Deployment: Web, iOS, Android, Windows
Q-Pulse quality management software solution from Ideagen offers comprehensive governance, risk, and compliance (GRC) solution for the life science industry as well as a variety of other industries, including aerospace and defense, manufacturing, healthcare, food, and drink.
It covers everything from document management to employee training, supplier management, quality control, safety, health and environment, audits, risk management, and more.
Q-Pulse helps automate, streamline processes and comply with specific industry regulations and standards such as ISO 13485, ISO 9001, ISO 27001, ISO 50001, ISO 22000, ISO 29001, and others.
Q-Pulse offers a high level of customization to their automated workflows, you can configure workflows, security settings, and alerts to match your organization’s standards and processes.
With real-time KPIs (key performance indicators), native apps for iOS and Android, and audit, document management, and reporting capabilities, Q-Pulse makes it easy to stay on top of your operations, quality, safety, risk, compliance, as well as collaborate in real-time while outside of the office.
Q-Pulse offers an annual subscription price.
Considerations about working with Q-Pulse:
Q-Pulse targets a very broad range of industries and allows you to build very specific workflows for your needs. If this is needed by your organization and you are willing to take on the required validation and re-validation tasks that come with highly customizable software, then Q-Pulse might be a good choice for you.
Services such as implementation, and validation (incl. IQ, OQ, and PQ) are not included in the subscription and are a separate purchase.
Greenlight Guru
Deployment: Web
Greenlight Guru is a cloud-based quality management software (QMS) designed to help businesses in the medical device industry streamline operations across multiple departments and teams. Out-of-the-box it is based on the latest FDA and ISO standards and best practices.
Greenlight Guru helps teams work smarter, not harder, by providing a centralized platform for managing all aspects of the product life cycle. From ideation to market launch, the platform makes it easy to track progress, ensure compliance, and measure success.
Greenlight Guru offers a variety of features such as historical data and electronic signature capturing, document management, training management, design control, risk management, non-conformance management, CAPA management, supplier management, change management, and more. The platform does not integrate with Microsoft Office, but it does have its own built-in, web-based document editor.
Greenlight Guru provides powerful design control, traceability, risk management tools, and integration to Jira, an industry-leading issue and project tracking tool, to help MedTech companies accelerate product development while maintaining compliance with FDA regulations.
The price of Greenlight Guru solution depends on the plan you choose. They offer three subscription plans, based on your lifecycle stage: Essentials, Plus, and Professional, all of which are billed annually and contain different features at different price points. They do not offer multi-user licenses.
Implementation (including data migration), and training services are not included in the subscription price and need to be purchased separately. The bulk of the validation is done by Greenlight Guru, although the PQ validation will need to be done by the customer.
Considerations when working with Greenlight Guru:
Greenlight Guru has strong capabilities in Requirement Management and their Professional Subscription includes a comprehensive set of features for medical device organizations. If you start using the Essentials Package, you should consider the eventual increased cost of upgrading to the Plus or Professional package at a late stage.
The built-in web editor allows you to edit your documentation in Greenlight Guru’s interface. If you prefer using an eQMS that is integrated with Microsoft Office, then you might want to consider other eQMS options.
Why Choose SimplerQMS All-In-One QMS Software?
SimplerQMS QMS Software was built specifically for the life science industry.
SimplerQMS allows you to streamline all your quality management needs in one place, from creating and managing SOPs and documents to tracking training records and conducting audits – increasing efficiency, reducing costs, and helping you ensure compliance at the same time.
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Connect Processes Quality Processes Across Entire Product Lifecycle
SimplerQMS provides unmatched QMS process support capabilities that help you track, manage and monitor quality processes throughout the product lifecycle – from design and development to manufacturing and post-market surveillance.
With SimplerQMS you can ensure that documents are filed in the right archives, linked to the correct R&D projects, and organized for specific regulatory submissions, in the right formats.
Manage products, parts, and components down to the batch record or serial number level – all in one place. Easily link these entities to both pre-and post-market activities such as equipment, risk management, design control, complaints, non-conformances, CAPAs, audit findings, and other processes.
Streamline and Automate Documentation Processes
With SimplerQMS you can easily author, review, and approve SOPs and other documents using an electronic document workflow. Assign tasks and due dates to the right people, and ensure they receive automatic notifications when a task is due or overdue.
Work on your documents using Microsoft Office applications such as Word, Excel, and PowerPoint, then save them directly into the SimplerQMS cloud with one click – no need to download and re-upload files. Track and manage revision history, and ensure that only the latest versions of documents are being used.
SimplerQMS also makes it easy to share documents with external parties such as consultants, suppliers, and customers. You can easily provide read-only or edit access to documents, and track who has accessed each document and when.
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Spend No Time On Software Validation
Validation can be a time-consuming and costly process, but with SimplerQMS it’s a thing of the past. Our software is pre-validated according to GxP, FDA 21 CFR Part 11, and ISO 13485:2016 requirements, so you can be up and running quickly – without having to spend time and money on validating the software yourself.
Unlike many of the other QMS software solutions on the market, we provide continuous re-validation, which is included in the price of the subscription, so you can be confident that our software is always compliant.
Ensure Regulatory Compliance and Maintain Audit Readiness
Regulatory compliance is at the core of what we aim to help our customers achieve.
SimplerQMS is purposefully designed to help life science organizations meet regulatory requirements such as FDA 21 CFR Part 11, ISO 9001, EU Annex 11, ISO 13485:2016, FDA 21 CFR Part 820, GxP, GAMP 5, EU MDR & EU IVDR, and others.
Features like FDA 21 CFR Part 11 compliant electronic signatures, time-stamped audit trails, version control, revision control, and document workflow ensure that you have the evidence you need to show during audits and inspections that your processes are compliant.
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Implementation and Training Included at No Extra Cost
When you subscribe to SimplerQMS you get full implementation, training, and support services included at no extra cost. Our team of experts will work with you to configure the QMS software to meet your specific needs and train your team on how to use it. By the end of the training, we will issue each trainee a training certificate.
Once you’re up and running, our team is available to answer any questions you may have and provide excellent ongoing support.
See What Our Customers Have to Say
“Spending most of my day using SimplerQMS, I would say I am very pleased with the ease of use.”
Dorthe W.
QA/RA Manager, Cortex Technology
“SimplerQMS gave us excellent pricing, customer support for understanding how to use their system and set up our QMS, and is easy to use.”
Subba S.
Chief Technology Officer, CollaMedix
“Easy to work with. Intuitive. Rather easy to setup. Very good customer support. Good quality to price ratio.”
Jean Claude M.
Head of Hardware and Software Development, hemotune
Support That Always Has Your Back
Online Training Sessions
During the implementation process, SimplerQMS will provide you with online training sessions to ensure that you and your team are up to speed on how to use the software.
Exceptional Customer Support
At all times, you will have access to our team of experts who are always on hand to answer any questions you may have.
Knowledge Base
In addition to our customer support team, you will also have access to our knowledge base which includes helpful articles, guides, and FAQs.
Learn More About SimplerQMS Today
Now that you know more about the best QMS software on the market, it’s time to evaluate which one is right for your life science organization. Let’s take the next step in streamlining your quality management journey today.
