What's the best regulatory compliance management software for life science companies?
For highly regulated pharmaceutical, biotech and medical device companies, the ability to manage your regulatory compliance efficiently can be a decisive factor in your operational success.
Regulatory updates, expansion into new markets and the need for constant, airtight audit readiness make regulatory compliance management software an indispensable tool for modern life science operations.
We'll be exploring what regulatory compliance management software is, why you need it, and which systems and providers you need on your shortlist.
Table of Contents
What is regulatory compliance management software?
Regulatory compliance management software refers to any digital platform specifically designed to help regulated companies meet the compliance requirements enforced by legislators and agencies.
These platforms are tailored to handle the unique demands of highly regulated industries.
Core functions and features
- Real-time compliance monitoring: Instant visibility into compliance health, gaps, and potential audit risks.
- Centralized document management: Secure, cloud-based storage, version control, and real-time access to all quality and compliance documents, from SOPs to policies and records.
- Automated workflows: Streamlined handling of compliance tasks, such as approvals, process updates and CAPAs.
- Audit trails and reporting: Complete records of changes and user actions, with audit-ready reporting for audits and inspections.
- Training management: Automated assignment and tracking of required employee training.
- Integration capabilities: Seamless connectivity with CRM, LMS, product development, and other external systems for holistic oversight.
The critical role of regulatory compliance management software in life science
Effective regulatory compliance is not only a legal requirement for life science companies, but a critical pillar of your quality assurance and risk management activity.
Yet compliance management, for many life science companies, remains highly manual and time-consuming.
Qualio industry research revealed that life science compliance teams spend, on average:
- 9 months preparing for entry into a new market
- 50 hours of gap analysis work for every new regulatory standard
- 4 hours a week preparing for internal and external audits
- 200 hours of consultant support per standard
With the complex modern patchwork of global regulations spanning everything from EMA and FDA expectations to ISO, IEC and ICH standards, these manual compliance approaches are no longer sustainable or scalable.
Why you need regulatory compliance management software
Adopting regulatory compliance management software delivers numerous strategic advantages for your organization.
These include:
- Faster product launches: Accelerate entry into multiple markets by streamlining submission and approval processes.
- Patient and consumer safety: Enhance quality control and traceability for better outcomes and minimized risk.
- Regulatory responsiveness: Stay current and compliant with shifting regulatory standards and expectations, such as the FDA's new QMSR.
- Risk reduction: Slice the risk of costly fines, product recalls and reputational damage through proactive monitoring.
- Efficiency gains: Replace fragmented, manual compliance processes with automated workflows and AI support.
Top regulatory compliance management software for life science
Modern regulatory compliance software platforms are designed to address the specific compliance needs of life science companies at every stage, from early R&D to international commercialization.
Here’s an in-depth look at some of the best platforms trusted by the industry.
1. Qualio
Best for: Life science businesses with 11-500 employees, looking to balance expansion and growth with best-in-class quality and compliance processes.
Strengths:
- Unique Compliance Intelligence tool that scans your entire QMS in 30-40 minutes, uncovering every compliance gap you need to close
- Pre-built life science eQMS content packages that save 6 months of document and process build time
- Intuitive, user-friendly cloud platform accessible from anywhere
- Rich suite of integrations
- End-to-end workflow automation for key compliance activity like document review, training and compliance tasks
Weaknesses:
- Not suitable for non-life science operations
- Not designed for extensive customization
- English language only, limited presence beyond North America, Australia and Europe
- No LIMS or clinical trial management functionality
Why choose Qualio?
- Only life science eQMS with built-in compliance management AI tool
- Purpose-built for life science companies, covering all the quality and compliance functionality you need
- Ranked easiest eQMS to use, with the strongest customer support and highest user satisfaction, on G2
- Proven impact for regulated life science companies, reported stats include:
- 80% faster readiness for audits and new standards
- 60% reduction in consultancy spend
- 5x ROI
- Hundreds of hours of manual quality & compliance work eliminated with automation
See how a pharma company achieved 5x ROI with our regulatory compliance management software
2. Veeva Vault
Best for: Multinational enterprise organizations.
Strengths:
- Advanced content and data management designed for global scaling
- Dedicated RIM module to support regulatory submissions, with LIMS and eTMF/CTMS functionality for labs and clinical trial providers
- Highly configurable to meet complex workflow requirements (but coming with complex GAMP 5 Category 5 validation considerations)
- Enables enterprise teams to collaborate across multiple products, sites and regions
Weaknesses:
- Priced for enterprise companies
- Complex, with long set-up and validation timelines
- No AI-powered QMS scans or gap analysis
- No in-app document collaboration/editing
- No pre-built life science templates/content
- No design control features for medical device regulatory compliance
3. MasterControl
Best for: Global enterprises with multiple product portfolios, who need complex, highly configurable regulatory compliance management software.
Strengths:
- Microsoft-based UX for familiarity
- Tons of 'bells and whistles' modules, with high connectivity between them
- Strong training, audit and supplier management functionality
- Industry giant, used by many regulatory agencies
Weaknesses:
- Expensive
- Challenging usability when lots of modules are in use
- No AI-powered QMS scans or gap analysis
- Some reported issues with system and search speed
- Web app only compatible with Internet Explorer
- Complex validation considerations
4. TrackWise
Best for: Organizations with complex product lines, requiring advanced analytics, or with global compliance footprints.
Strengths:
- Powerful approach to analytics and custom reporting
- Lots of integrations
- Designed with multi-site implementations in mind
- Highly configurable for enterprise operations
Weaknesses:
- Unintuitive UX can slow and blunt internal adoption
- No AI-powered QMS scans or gap analysis
- No pre-built life science templates/content
- Not designed specifically for life science companies
- No native document building, editing or collaboration
How to choose the right regulatory compliance management software
Choosing regulatory compliance software is a major decision that can shape your organization’s entire approach to quality and compliance.
Consider the following best practices and criteria to guide your search:
1. Industry and use case alignment
- Does the platform offer content, workflows and functionality relevant to your sector?
- Are there case studies or references from similar organizations demonstrating real-world results?
2. Standout features
- Do any systems offer regulatory compliance functionality you can't get from their competitors - like Compliance Intelligence from Qualio?
- If so, what impact would that functionality have on your business?
3. Scalability and adaptability
- Can the platform support your current and anticipated compliance plans, such as new products, markets or regulatory regimes?
- How easily can workflows, permissions and features be adapted as your business evolves?
4. Regulatory coverage
- Does the system support all the life science regulatory frameworks that matter to you: FDA 21 CFR Part 11, ISO 13485, ICH Q10, and so on?
- How quickly does the vendor update for new or revised standards?
5. Ease of use and adoption
- Is the user interface intuitive, especially for non-technical or non-QA/RA team members?
- Are onboarding and customer support robust to ensure rapid implementation and return on investment?
6. Audit and inspection readiness
- Does the software give you everything you need to prepare for audits and inspections — and pass them successfully?
- Is the system easy to use and intuitive, so it's ready for inspection by an external auditor?
7. Security and integration
- Is the tool, and your data within, managed and protected in accordance with recognized quality and information security standards such as ISO 9001, ISO 27001 and ISO 27701?
- Can the platform integrate with your existing business tools, such as your CRM, product design or learning management systems?
Frequently asked questions (FAQs)
How does regulatory compliance management software help life science companies?
Regulatory compliance management software replaces manual, time-intensive compliance processes with automated workflows, centralized, digital data, and real-time visibility of your compliance status.
Why should life science organizations adopt regulatory compliance management software?
Manual, analog compliance processes don't just cost time and money for your business — they open your business to the risk of audit findings, regulatory fines and recalls. Regulatory compliance management software brings life science product lifecycle control, risk management and audit readiness into one environment, unlocking visibility of your compliance landscape and giving you much stronger control of your quality and compliance processes.
What distinguishes an eQMS from regulatory compliance management software?
While an electronic quality management system (eQMS) focuses on quality management processes like document and training management, regulatory compliance management software is designed to ensure those processes meet regulatory expectations and compliance standards. The best platforms, like Qualio, integrate both sets of capabilities in one system.
Is it safe to use cloud-based compliance software?
Any reputable cloud platform should prioritize strong data security, privacy controls, encryption and regular compliance audits. However, it's down to you, the customer, to confirm any potential provider’s adherence to relevant security standards (like ISO 27001) and ensure your own internal supplier management policies are fit for purpose.
How important is vendor support for areas like validation?
Extremely. Strong vendor support simplifies your regulatory compliance management software deployment, getting you up, running and confident faster. Ready-made validation materials and expert guidance are a key step to launching a system that's well-adopted, properly established, and ready for audits and inspections.
The impact of specialized regulatory compliance management software
For companies making medical device, pharmaceutical or biotech products, the right regulatory compliance management software transforms compliance from a burden and timesink into a business enabler.
Solutions like Qualio, Veeva Vault, MasterControl and TrackWise allow regulated organizations to:
- Minimize your compliance risk
- Accelerate market access
- Build and maintain a reputation for quality and compliance
- Respond proactively to regulatory updates
Whether your team is preparing a new pharmaceutical breakthrough, advancing biotech research across borders or building an innovative SaMD platform, investing in purpose-built regulatory compliance management software is a critical step to growing with confidence into one of the most strictly regulated industries on Earth.
