The Novyra eSystems Advantage
One unified, compliant, cloud-based platform - built for growing teams
Secure, cloud-based, 21 CFR Part 11-compliant system.
Unlock the Benefits of eSystems, your Pre-validated Compliance Platform:
- focused on the features that you really need
- no pre-canned processes that are unsuitable
- no hidden costs and distraction of in-house validation
- designed to accelerate product development and market entry
- we take the IT burden
eTMF
eQMS
eLMS
Clinical trial document management in a secure, compliant manner.
- TMF Reference Model
- Audit and Inspection Readiness
- Real-Time Visibility
- Seamless Collaboration
- Integrated Processes
- Automated Workflows
- Scalable by Design
- Auditable Training Records
- Integrated with QMS
- Compliance Watchdog
eTMF
Clinical trial document management in a secure, compliant manner.
- TMF Reference Model
- Audit and Inspection Readiness
- Real-Time Visibility
- Seamless Collaboration
eQMS
- Integrated Processes
- Automated Workflows
- Scalable by Design
eLMS
- Auditable Training Records
- Integrated with QMS
- Compliance Watchdog
Scales as you Grow
Your business doesn’t stand still, and neither should your systems. eSystems grows right along with you, adding new functionality when you need it. No fuss, no downtime. It flexes to fit your evolving workflows and processes, keeping your compliance as agile as your innovation.
Hand over the complexity to us - let your team focus on what they do best: Innovation
Here's how we help:
Rapid, Guided Onboarding
Get started fast – no IT or QA resources needed. Pre-configured templates, installation road maps and guided setup get you live in 2–4 weeks.
Out-of-the-Box Validation
Stay compliant from day one with a complete validation package and continuous system update management.
Quality & Compliance Services
Go beyond software. Tap into our company’s regulatory expertise.
Predictable, Scalable Partnership
A streamlined subscription model that scales with your growth, freeing capital for core business and inspiring investor confidence.
Work with a trusted partner: Our team brings extensive experience in data management, quality management systems, statutory and regulatory requirements, and post-merger integration. Our expertise in compliance, risk management, and lean processes enables us to support life sciences startups maximise the value of data through robust, cost-effective processes and systems.
In summary, Novyra enhances efficiency, mitigates risk, and allows your team to prioritize scientific work over administrative burdens.
Full Compliance, Zero Complexity
Novyra eSystems is built for life science professionals by life science professionals.
It delivers full compliance from day one – rapid to deploy, effortless to manage, and aligned with every major regulation.
Secure Technology Backbone
Built on Microsoft 365 / Azure with 256-bit encryption, private VPNs, and dedicated tenants for full data control. Backup and replication ensure reliable protection.
A Strategic Partner for Innovation
Navigating the life sciences sector is challenging for startups, particularly with a reported 77% shortage of qualified life science and healthcare talent across Europe.
Internal tasks like software validation and system implementation can quickly become a drain on your team’s time and focus.
That’s where we come in! With our eSystems platform and deep industry experience, we serve as your single point of accountability for compliance and IT maintenance.
Who We Serve
From consulting roots to a unified life science integration platform, our journey has been about one mission: enabling small and mid-sized life science innovators to thrive in a complex, regulated world, turning bold ideas into approved, life-saving therapies.
Whether you’re a biotech innovator, a medtech disruptor, or a fast-growing research and development team, Novyra supports ambitious organizations that refuse to let compliance slow them down.
eTMF - Trial Master File
Manage all essential clinical trial records in a secure, compliant, and organized manner
Audit and Inspection Readiness
Real-TimeVisibility
Seamless Collaboration
Always be prepared for an audit or inspection with a 21 CFR Part 11 compliant, validated system.
Proactively manage your trial with reporting on TMF completeness, timeliness, and quality.
A single source of truth, eliminating administrative chaos and version control issues.
Audit and Inspection Readiness
Always be prepared for an audit and inspection with a 21 CFR Part 11 compliant, validated system.
Real-TimeVisibility
Proactively manage your trial with reporting on TMF completeness, timeliness, and quality.
Seamless Collaboration
A single source of truth, eliminating administrative chaos and version control issues.
- Built to Industry Standard: Pre-configured with the TMF Reference Model.
- Version Control: Automated management of document revisions.
- Immutable Audit Trails: Complete, time-stamped history of every action.
- 21 CFR Part 11 eSignatures: Compliant, legally binding electronic approvals.
- Quality Control Workflows: Integrated and tracked review and QC processes
- Flexibility for Growing Teams: We match your way of working.
eQMS - Quality Management System
Built-in Best Practices Quality Management
Integrated Processes
Automated Workflows
Stay Validated
Scalable by Design
Manage deviations, change management and audits in one system.
Streamline SOP management with review and approval cycles using compliant e-signatures.
Eliminate the validation burden, saving you significant time and cost.
Our platform grows with you, from your first pre-clinical study to global post-marketing studies.
Integrated Processes
Manage deviations, change management and audits in one system.
Automated Workflows
Streamline SOP management with review and approval cycles using compliant e-signatures.
Stay Validated
Eliminate the validation burden, saving you significant time and cost.
Scalable by Design
Our platform grows with you, from your first pre-clinical study to global post-marketing studies.
- SOP Lifecycle Management supported by integrated Learning Compliance module.
- Reporting & Analytics for tracking quality trends and identifying systemic issues.
- Change Control: Formal, auditable process for managing changes to validated systems and processes.
- End-to-End Traceability: Electronic links between deviations, CAPAs, SOPs, and training?
- Built to ISO standard: Built to ISO 9001:2015, the globally recognized standard for quality management.
eLMS - Training Compliance
Customizable, flexible, lightweight learning management
Streamlined Training Management
Integrated with QMS
Inspection Readiness
Manage, assign, track, and document GxP training using a simple, easy-to-use interface.
Automated process to monitor compliance and collect training records.
Generate complete, compliant training files on-demand.
Streamlined Training Management
Manage, assign, track, and document GxP training using a simple, easy-to-use interface.
Integrated with QMS
Automated process to monitor compliance and collect training records.
Inspection Readiness
Generate complete, compliant training files on-demand.
- Training Matrix: Centralized tool for defining role-based training requirements.
- Content Flexibility: Supports documents, presentations, videos, and links to external materials.
- Automated Assignments & Reminders: Intelligent workflows to manage the entire training lifecycle.
Take Action: Book a Demo to see Novyra eSystems in action.
Platform Compliance
Novyra eSystems is a secure, cloud-based platform that complies with 21 CFR Part 11 regulations for Quality Management Systems, eTMF, Technical Files, and data repositories.
Novyra eSystems is compliant with:
- U.S. FDA, Code of Federal Regulations, Title 21 Part 11, Electronic Records; Electronic Signatures
- EudraLex The Rules Governing Medicinal Products in the European Union – Volume 4 – Good Manufacturing Practice – Medicinal Products for Human and Veterinary Use- Annex 11: Computerised Systems
- U.S. FDA Data Integrity and Compliance with CGMP – Guidance for Industry (Final Guidance), 2018
- ICH-GCP Guideline for good clinical practice E6(R3)
- ISO/IEC 27001:2022 – Information technology – Security techniques – Information security management
- General Data Protection Regulation (Regulation (EU) 2016/679)
Novyra eSystems is audit-ready: We are always ready to pass on-site or remote audits and fill in any assessment questionnaire from your quality assurance team.
Technology
Microsoft Azure and Office 365
Novyra eSystems utilizes Microsoft technology to manage all documents, data, and processes within our system. Microsoft delivers the platform, and Novyra eSystems operates reliably on Microsoft SharePoint, a well-known and efficient working environment for your organization and employees.
Microsoft retained Montrium, an independent organization specializing in quality assurance and regulatory GxP compliance for the life sciences industry, to conduct the GxP qualification review for Microsoft. The Qualification Guidelines for Azure and Office 365 are designed for life sciences organizations looking to utilize these cloud services for hosting and supporting GxP-regulated computerized systems.
Novyra eSystems builds GxP solutions on Azure and Office 365, leveraging the cloud’s efficiencies while protecting patient safety, product quality, and data integrity. Novyra eSystems also benefit from multiple layers of security and governance technologies, operational practices, and compliance policies that enforce data privacy and integrity at specific levels.
We have a list of prequalified Data Centers according to our SOPs. Location of servers and backups are agreed and reflected in the Service Level Agreement. Exact Data Center location and type depends on the Client’s requirements. Currently, we work with Data Centers in Denmark.
Your Novyra eSystems instance runs on a dedicated Microsoft 365 tenant. This ensures that your data and setup will always be yours – even if we part ways or our company is sold or ceases trading.
Veeam® Backup & Replication
Veeam® Backup & Replication is a 4-in-1 backup and recovery solution for storage snapshots, backups, replicas and continuous data protection in one product. Veeam® is the industry leader, ensuring secure and reliable protection for our cloud, virtual and physical workload needs.
Veeam® Backup & Replication delivers dependable availability across all Novyra eSystems, virtual and physical workloads with a simple, flexible and reliable solution. Protect our data no matter the location or workload type with powerful backup and instant recovery options.
Security
Our enforced security with 256-bit encryption keeps your documents and data effectively secured and protected. We can also provide private VPN tunnels for secure transmission over the internet.