Many categories of open source software are growing explosively as viable options for organizations as diverse as IT operations, DevOps, and Data & Analytics. Open source, “free” technologies like Linux and Hadoop have captured an enormous market share. For certain use cases, like big data warehousing, open source software makes sense.
However, are open source options viable for highly regulated industries and use cases? How does open source vs. subscription Quality Management Systems software stack up in terms of pros, cons, costs, and regulatory risks?
Open source software is a viable choice for some industries, applications, and use cases and claiming otherwise would obviously be biased. There’s a fair chance you’re reading this article using at least one open source technology right now, including Firefox web browser or a phone with an Android operating system. However, can you trust an open source QMS software to accommodate regulatory requirements like Part 11 or revalidation processes, and if so, is an open source software the smartest financial choice for startups, scale-ups, and small companies in highly regulated industries?
A QMS software represents a big investment for companies of any size. Whatever solution you choose should be a system which can scale and grow with your organization. Read on to learn whether open source or subscription QMS is the right choice for your organization and the pros, cons, and top choices within each category.
Open Source vs. Subscription QMS Software
Open source QMS software is developed and licensed in a collaborative model which provides users with the right to change and distribute the software for any purpose, including commercial use.
Subscription QMS software is licensed under a Software as a Service (SaaS) model which includes paid support and guaranteed service levels, sold for a set period of time under a guaranteed pricing model. QMS software, or an electronic Quality Management System (eQMS), is a centralized system to help organizations achieve goals of innovation, quality, and compliance.
The right Quality Management System software can create consistency and deliver bottom-line boosting benefits such as consistent product quality, minimized mistakes, and stronger customer satisfaction.
Is open source QMS or subscription QMS software the better choice for your organization? While each of these licensing approaches to eQMS carries distinct pros and cons, the open source approach to eQMS may not necessarily be cheaper. Depending on your organization’s internal support resources, saving money on licensing by going the open source route could even spell increased regulatory risk or a loss of competitive advantage.
Open Source QMS Software
Across all industries, more than half of organizations say their company uses open source software or plans to adopt it in the near future (53 percent). Large organizations are nearly twice as likely to run open source solutions as smaller companies, with nearly 63% of bigger enterprises using one or more open source solutions compared to just 37% of smaller firms. Adoption is lower in highly regulated industries. As open source software adoption has expanded significantly, it’s valuable to understand the various forms an open source software project can take and the different types of OS licensing:
- Community Open Source: Project-based open source technologies are managed by a community of volunteer developers who are not paid for their collaborative efforts to maintain a technology. Well-known examples of community open source technologies include Linux and Apache.
- Commercial Open Source Software (COSS): Commercial open source software are open source projects which involve paid developers and a managerial structure. The technology is backed by an open-source code repository which is copyrighted, patented, and/or trademarked by a company. The software may be distributed for free, or for a nominal fee. Some of the largest COSS technologies may offer premium services including support, which cause the lines between open source and subscription-based technologies to become very blurred. Examples of COSS technologies include MongoDB and WordPress.
Based on the remarkable variety of technologies and organizations in the open source space, it’s important to understand that the quality of an eQMS can vary depending on whether a solution is a community project or a COSS technology. However, many of the pros and cons of an open source eQMS are standardized across options.
Pro #1: Free to Try
While many subscription-based softwares offer a 30-day trial to take a test drive, the majority of open source software is legitimately free. Your organization can test multiple options to determine whether a solution is the right fit, including a test drive without installation as “live media.” The only cost to perform this trial is generally your time commitment, which may be significant.
Pro #2: Free, Limited Support
Most open source software includes some support which is offered free-of-cost to users. This generally consists of an online community of users, including discussion forums and a space for asking questions which can be answered by other installed users or, in some cases, product experts. The quality and speed of these answers can vary significantly depending on the size of the user base.
Pro #3: Open Standards
Many open source projects offer “open standards” for communications and data formatting, which allows organizations to create interoperability within the organization’s technology stack.
Pro #4: Community Bug Fixes
Many open source software projects lack a large staff of paid developers and information security engineers and instead rely on community-based bug fixes. If your organization has internal development resources, you can identify and fix issues in the software internally.
Pro #5: Minimal Vendor Lock-In
Your organization is unlikely to find yourself locked into a proprietary software or long-term licensing contract with an open source product. While you may invest too many development resources to easily switch vendors, you won’t be dealing with the same types of vendor lock-in which can occur with proprietary software, especially legacy licensed software options.
Con #1: Reduced Industry Advantage
An open source eQMS may not have the same advantages as a subscription-based eQMS designed specifically for the needs of startups and scaleups in highly regulated industries. While an open source solution can offer the basic building blocks, your organization may have to build in features and workflows to conform with your quality management system such as ISO 9001 or regulatory requirements and perform manual updates to meet emerging compliance requirements.
Con #2: No Real-Time Support
Large open source projects have a vast array of community support resources, including extensive documentation and community forums. However, free support is rarely fast or personalized. If you select a niche eQMS software, you’re unlikely to access the broad user base necessary for extensive help with your solution. Your organization could be left to navigate the design, implementation, customization, and troubleshooting of a solution on your own.
Con #3: Complexity
While there are rare exceptions, open source software projects are generally marketed towards organizations who have in-house development resources and technology experts on staff, including skilled users who will take advantage of the source code offering. For some organizations and applications, having access to the source code for deep customization can be a benefit. For startups with limited technology resources, downloading a complex piece of software with limited documentation and instructions can be overwhelming and a barrier to success.
Con #4: Increased Risk
Many open source software projects are maintained by communities of developers or small organizations. These companies may fold during the period of time you’re using their product. In an open source model, you can likely continue to use a product while you search for a new solution. However, you may have even more limited access to revalidation support and patches when the product reaches end-of-life.
Examples of Open Source QMS Software
Momentum is a truly open source software which is designed as a quality management solution for organizations in various industries, including manufacturing, food safety, and medical fields. The integrated modules include compliance, risk, and training management. Features included do not address CAPA, audits, or document control.
FlinkISO is advertised as an “open source QMS solution” which can be deployed as a premises-based cloud solution for global accessibility. While FlinkISO is positioned as an open source solution, it’s delivered by a COSS organization and sold under a subscription model with pricing options clearly listed online.
Subscription QMS Software
The meteoric growth of subscription-based software has created a technological ecosystem described as the “service economy.” According to a Cisco survey, 73% of organizations say nearly all of their apps will be cloud-based SaaS apps by 2020. Subscription applications are targeted solutions to fit the needs of niche use cases and verticals, such as the need for compliant eQMS at fast-growing organizations in the pharmaceutical, medical device, and biomedical industries.
Pro #1: Specialization
Assuming you’ve selected an eQMS subscription software designed for your industry, you’re purchasing a product backed by a company which understands the regulatory requirements of Part 11 (or the applicable requirements for electronic data security and integrity in other countries). In an open source model, you’re far less likely to find a similarly specialized product which is kept up-to-date by subject matter experts. You are likely to bear the responsibility to maintain the open source software on your own servers, which requires individuals with specialized programming expertise. Hiring development talent can be a costly challenge for small organizations in the startup world.
Pro #2: Outsourced Maintenance
The SaaS model allows your organization to fully outsource all the back end maintenance and management of the application, including data backups in compliance with regulatory requirements and security patching. By choosing a proprietary, cloud-based solution over open source, you are paying a higher fee up front for acquisition. However, this includes the expectation that the vendor will supply you with a product that is kept up-to-date, free of bugs, and maintained during the lifetime of your subscription.
Pro #3: Stability and Usability
Competition among subscription software vendors is fierce, and for a subscription QMS vendor to survive and maintain a client base, they need to continually deliver a high-quality product. This includes performing regular updates and improvements to the feature set and user experience and performing maintenance activities that stabilize the product’s value for clients. Open source products may be maintained by an active community of users, but they’re rarely subject to significant improvements for the purpose of client satisfaction.
Pro #4: Customer Support
Quality management software implementations can be complex. A huge advantage of selecting proprietary, subscription-based software over open source solutions is the depth and availability of support which can be purchased from many vendors. Since many SaaS providers offer a narrow product, their staff can offer deep expertise on successful implementations at pharma, biomedical, and medical device startups. This can offer an enormous advantage in quickly realizing value from a new eQMS system, especially when compared to the documentation and online forum support options associated with many open source softwares.
Con #1: Dependency
Purchasing a proprietary software can spell dependency on your vendor. If the vendor dramatically changes their pricing structure or doesn’t deliver new features, you’re stuck evaluating whether to switch to a new vendor or use a product which wasn’t what you expected. Dependency is a risk with any software investment, and the customization costs of an open source deployment can quickly reach or even exceed a subscription implementation. To avoid the risk of dependency on any product which doesn’t meet expectations, clearly discuss your growth goals with your vendor to understand whether a product can scale to your expectations.
Con #2: Extensibility and Customization
By definition, purchasing a subscription to a proprietary, closed-source software can mean your organization has less access to the source code than you might expect with an open source alternative. For some organizations, such as massive enterprises with significant in-house development resources, this is a disadvantage. For the majority of organizations, there’s very little need for the ability to personally customize and configure the source code. Determine whether a product can be configured to meet your organization’s model and workflow needs and whether a vendor’s business model supports your need for extensibility and customization.
How Much Does Subscription Quality Management Software Cost?
The cost of a subscription to a quality management software can vary significantly depending on the size of your organization and the number of users. However, Qualio’s pricing ranges from $850 per month for startups and small teams to $7,500 per month for enterprise organizations. Other variables which can impact the upfront and ongoing cost of an eQMS subscription include:
- Billing Structure (Monthly vs. Annual)
- Data Storage Costs and Overages, if Applicable
Example Subscription QMS Softwares:
MasterControl is a well-known quality management software designed to serve as a comprehensive QMS software throughout the entire product lifecycle for bringing products to market and increasing operational efficiency. MasterControl is primarily marketed towards organizations with 200 or more employees.
Trackwise by Sparta Systems is a solution designed to offer extensive flexibility and configuration features to large organizations, defined primarily as enterprises with 1,000 or more employees, in a variety of highly regulated industries.
Qualio is a comprehensive, cloud-based quality management software for highly regulated organizations in a variety of industries, including pharma, medical devices, and cosmetics. Key features include document management, collaboration, employee training, and audit trails. Qualio has an average of 5/5 star review ratings from verified adopters on SoftwareAdvice.
Open source technologies and subscription-based software are both growing rapidly as technology models for business. There’s value to both approaches for varying use cases, niches, and industries. While an open source quality management system could be the right choice for some firms with extensive resources for custom development, revalidation, and compliance, it’s wise to consider the pros and cons of this approach fully before you select a “freeware” solution.
Due to the unique role and requirements for an electronic quality management system in highly regulated industries such as pharmaceuticals, medical devices, and life sciences, an open source solution could spell increased risk or loss of advantage. In general, a subscription-based solution which is designed specifically for the needs of an organization similar to your own is most likely the better choice than an open source solution if:
- Your end user base lacks significant development talent to customize and maintain the source code
- You need extensive functionality and compliant features out-of-the-box
- Your organization is hoping to fully outsource product maintenance, data security, and updates
- Your organization has a need for product design support or ongoing support
- An application’s performance is mission-critical to the success of your business and product quality
Open source solutions can be the right answer, but they’re rarely the lowest-risk or most cost-effective approach for startups and scale-ups in highly regulated industries. By selecting a subscription-based quality management system software which is built to scale, your organization can create a strong and compliant baseline, and focus resources towards growth.
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