In regulated industries like pharma and MedTech, a Quality Management System (QMS) needs to do a lot more than check off a compliance checklist.
It's a core part of how teams ensure compliance, maintain traceability, and protect patient safety. Whether you're preparing for an FDA inspection, managing CAPAs, or tracking training across global teams, your QMS has to support the way your organization works and meet regulatory expectations every time.
But not every QMS is designed for life sciences.
This guide highlights the 7 best QMS software options available today that can meet the needs of pharmaceutical, biotech, and medical device teams.
If you’re evaluating systems to move beyond spreadsheets, transition from a legacy tool, or find something easier to manage, this list will help you compare options.
Any QMS can help organize documents. The right one helps you stay compliant, inspection-ready, and in control as your business grows.
When evaluating QMS platforms for pharma or MedTech, look for these key capabilities:
21 CFR Part 11 compliance
Electronic signatures and audit trails must meet FDA requirements for data integrity and traceability.
GxP validation support
A QMS used in regulated workflows must be validated. Some vendors provide full validation packages, while others leave it entirely up to you.
Configurable workflows
Your QMS should match your existing SOPs. Look for systems that let you define your own CAPA, deviation, and training processes instead of forcing you into rigid templates.
Integrated document control
Documents, quality events, and training should live in a single system. If your team has to bounce between tools, version control and compliance risk increases.
Role-based access and permissions
You should be able to control exactly who can see, edit, or approve content at every stage.
Scalability and usability
The system should be easy enough for teams to adopt quickly and flexible enough to support growth across products, geographies, and regulatory pathways.
Some teams also look for additional capabilities like audit management, supplier qualification, or integration with eTMF and regulatory submission tools.
Kivo is the only QMS on this list designed specifically for the needs of pharmaceutical, biotech, and medical device companies. It was built to support regulated teams from early development through commercialization, with all the core quality workflows you need and none of the overhead you don’t.
Unlike general-purpose QMS platforms, Kivo includes support for quality management, regulatory submissions, and clinical documentation in a single system. There's no syncing or transferring between modules, because everything runs on one validated document management system. That means fewer silos, faster reviews, and less duplication.
Kivo is pre-validated for GxP use, and includes built-in tools for managing:
CAPAs
Deviations
Change control
Training records
SOPs and controlled documents
Internal and vendor audits
Every workflow is fully configurable, so you can align the system with your SOPs instead of working around someone else’s structure. It also supports role-based permissions, electronic signatures, audit trails, and document versioning out of the box.
For teams used to managing quality in spreadsheets or SharePoint, Kivo offers a fast path to full compliance without the heavy lift of traditional enterprise software.
Best for: Life sciences companies that want a modern, flexible QMS built for their industry.
Veeva Vault QMS is one of the most recognized names in the life sciences software space. It’s part of the broader Veeva Vault suite, which includes modules for regulatory, clinical, and quality teams. The system is highly configurable and supports global, multi-site operations with complex compliance needs.
Veeva is built to meet the demands of enterprise pharma and MedTech organizations. It offers deep functionality for CAPA, training, audit management, and controlled documents, all within a validated, Part 11–compliant environment.
The tradeoff is complexity. Implementing Veeva requires significant time, planning, and internal resources. Many smaller teams find the system too rigid or expensive to be practical unless they have a dedicated IT or quality systems group.
Best for: Large enterprises needing enterprise-scale quality and regulatory integration.
MasterControl is another well-established QMS platform in the life sciences industry. It has been used by pharma, biotech, and MedTech companies for decades and includes robust support for FDA and ISO compliance. Like Veeva, it offers extensive functionality for CAPA, document control, audit management, and training tracking.
MasterControl provides a validated environment and offers tools and templates to accelerate deployment. However, the system can be inflexible for teams with unique SOPs or evolving processes. Customization is possible, but often requires professional services or ongoing administrative support.
Many companies adopt MasterControl during late clinical stages or after commercialization, but some eventually look for more modern, user-friendly alternatives as internal needs shift.
Best for: Established life sciences organizations that want a proven QMS with a full suite of enterprise features.
ETQ Reliance is a modular QMS platform used across a range of regulated industries, including pharmaceuticals, medical devices, food and beverage, and chemicals. While it isn’t dedicated to life sciences, the platform includes templates and configurations that support 21 CFR Part 11 compliance and ISO 13485 requirements.
ETQ offers strong document control, CAPA workflows, audit management, and risk analysis tools. Its flexibility makes it appealing to cross-functional organizations or teams with hybrid regulatory needs. You can build workflows that align closely with your SOPs, though some life sciences teams may need to do additional work to meet validation requirements.
ETQ does not provide a pre-validated environment. If you're operating in a GxP-regulated space, your team will need to own the validation process internally or partner with a third party.
Best for: Teams that need a flexible QMS to support multiple compliance frameworks, including life sciences.
QT9 QMS is a cloud-based quality system used across a variety of industries, including manufacturing, medical devices, and pharmaceuticals. It covers many of the core functions life sciences teams need, including CAPA tracking, document control, audits, nonconformances, and training management.
What makes QT9 appealing to smaller or early-stage teams is its simplicity. The system is relatively easy to set up, offers modular pricing, and includes features like electronic signatures and audit trails that help support Part 11 compliance. However, it is not pre-validated, so regulated organizations will need to manage their own validation efforts.
While QT9 does not focus specifically on life sciences, it can be adapted to meet FDA and ISO standards with some configuration. It’s a good step up from spreadsheets for companies that want better control without a long implementation cycle.
Best for: Small or growing teams in regulated industries looking for a quick, affordable QMS setup.
Arena QMS, part of PTC’s broader product lifecycle management (PLM) suite, is a strong QMS fit for MedTech companies and hardware-focused teams that need to manage both product data and quality processes in one place. It’s not a life sciences–exclusive platform, but it does offer support for FDA and ISO requirements, including ISO 13485 and 21 CFR Part 820.
Arena stands out for companies that need close alignment between engineering, manufacturing, and quality. It allows teams to link quality events to specific parts, assemblies, or product configurations, making it particularly useful for complex bill-of-material (BOM) management.
That said, Arena is primarily a PLM tool that added QMS capabilities. It’s less suited for clinical-stage teams or those looking for built-in support for regulatory submissions or validation documentation. You can configure it to meet life sciences requirements, but it takes more effort compared to platforms built for the space.
Best for: MedTech and hardware-driven teams that need PLM and QMS in a single system.
Qualtrax is a general-purpose compliance and document control system used in industries like testing labs, environmental sciences, and manufacturing. While not built specifically for life sciences, it includes many features that can support regulated pharma and MedTech workflows.
The platform offers strong document management, training records, workflow automation, and audit trails. It also includes electronic signatures and access controls that can help support 21 CFR Part 11 compliance, although some configuration may be needed to fully align with FDA or ISO expectations.
Qualtrax does not provide a pre-validated environment and doesn’t offer specialized life sciences modules. For teams that are primarily focused on lab operations or quality documentation and don’t need regulatory submission tools, it can be a solid option.
Best for: Quality and lab teams in regulated industries that need structured compliance without full GxP or submission support.
| QMS Platform | Life Sciences–Focused | Pre-Validated | 21 CFR Part 11 Support | Cost | Best For |
|---|---|---|---|---|---|
| Kivo | ✅ Yes | ✅ Yes | ✅ Yes | 💲💲 | Life sciences teams that want a purpose-built, configurable QMS |
| Veeva Vault | ✅ Yes | ✅ Yes | ✅ Yes | 💲💲💲 | Large enterprises needing enterprise-scale quality and regulatory integration |
| MasterControl | ❌ No | ✅ Yes | ✅ Yes | 💲💲💲 | Mid-to-large life sciences orgs wanting proven enterprise functionality |
| ETQ Reliance | ❌ No | ❌ No | ✅ Yes | 💲💲 | Teams needing flexibility across multiple compliance frameworks |
| QT9 QMS | ❌ No | ❌ No | ✅ Yes | 💲 | Small or growing regulated teams moving off spreadsheets |
| Arena QMS | ❌ No | ❌ No | ✅ Yes | 💲💲 | MedTech companies with PLM and hardware coordination needs |
| Qualtrax | ❌ No | ❌ No | ✅ Yes | 💲 | Lab and compliance teams with basic life sciences needs |
Choosing a QMS for medical devices, pharma or biotech isn’t just about ticking boxes. It’s about finding a system that matches your stage, your structure, and your regulatory responsibilities.
Here are a few questions to guide your decision:
Are you a life sciences company with GxP requirements?
If so, look for platforms that are either pre-validated or offer strong validation support. Systems like Kivo, Veeva, and MasterControl are built with this in mind, while others may require more internal effort.
Do you need flexibility or structure?
Some tools offer rigid workflows that are great for teams that want a plug-and-play approach. Others, like Kivo or ETQ, are more configurable and can be tailored to your SOPs.
What’s your current size and future scale?
If you're a small or mid-sized team, a tool like QT9 or Kivo can help you get compliant quickly without overcommitting to enterprise complexity. If you're already operating globally, Veeva or MasterControl may be more aligned with your scale.
Will your QMS need to connect to regulatory or clinical workflows?
Most generalist QMS platforms stop at quality event tracking. If you need a system that also supports eTMF, RIM, or submission tracking, Kivo is the only option on this list that natively supports those use cases.
How much internal support can you dedicate to implementation and validation?
Teams without dedicated validation or IT resources often benefit from systems that are pre-validated and easy to configure out of the box.
If you’re still managing CAPAs, deviations, training, or audits in spreadsheets or manual systems, you’re taking on more risk and overhead than necessary. Regulatory requirements continue to evolve, and inspectors expect traceability, version control, and audit readiness that spreadsheets can’t reliably deliver.
A dedicated QMS helps eliminate version confusion, missed deadlines, and reactive compliance work. But for life sciences teams, not just any QMS will do. You need one that understands the nuances of GxP, supports 21 CFR Part 11 requirements, and can grow with you from early development through post-market support.
That’s where a purpose-built solution like Kivo becomes more than just a compliance tool. It becomes a strategic asset, helping your team move faster, collaborate more effectively, and stay inspection-ready at every stage.
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