Ovation LIMS
By Ovation
Kickoff & Planning:
Introduction of Ovation Project Manager and transition from sales to implementation.
Kickoff meeting to review objectives, milestones, and expectations.
Completion of a Compendium document to gather foundational information for configuration.
Creation of a detailed project plan with timelines and deliverables.
Establishment of regular (weekly) meeting cadence.
Access to eLearning modules for initial training.
Configuration & Functional Testing (Sandbox Environment)
Configuration of the sandbox environment based on requirements.
Foundational and custom workflow training for Project Managers/System Administrators.
Iterative testing of the sandbox configuration by your team, with feedback to Ovation for adjustments.
Development and testing of any required third-party integrations.
Completion of a final testing checklist and authorization for production build.
Production Build & System Validation:
Migration of the tested sandbox configuration to the production environment.
System validation in production according to Ovation’s validation guide and regulatory requirements.
Addressing any issues found during validation, with possible configuration changes as needed.
Go-Live
Deployment of Ovation LIMS to end users for live sample processing.
Dedicated support period for the first 30 days post go-live, with a single point of contact for technical support.
Highly Customizable Workflows:
Ovation LIMS allows laboratories to tailor workflows to fit complex and unique molecular diagnostic processes, reducing turnaround time and eliminating the need for workarounds.
The system is designed to simplify even the most complicated workflows, making it adaptable as laboratory needs evolve.
Flexibility for Business Growth:
Laboratories can quickly add new lines of testing and modify workflows to adapt to changing business requirements or regulatory landscapes.
The platform supports rapid deployment of innovative genetic and molecular tests, enabling labs to stay competitive and responsive.
Custom Fields and Configurable Features:
Ovation LIMS provides options to create custom fields and configurable workflows, allowing organizations to mirror their specific operational processes and data capture requirements.
Administrators can generate custom reports and maintain compliance with internal SOPs and external regulations.
Integration with Third-Party Systems:
The platform offers robust integration capabilities with electronic medical record (EMR) systems and other third-party tools, ensuring seamless data exchange and compatibility with existing IT infrastructure.
Support for Complex, High-Throughput Environments:
Ovation LIMS is purpose-built for genetic and genomic testing labs, supporting collaboration, data management, and patient results reporting in high-throughput and precision medicine environments.
The platform is engineered to scale with the needs of each individual lab, from sample tracking to business analytics.
User and Access Control Customization: Features such as access control, role-based permissions, and audit trails allow labs to define user roles and maintain data security in line with business policies.
Client Portal and Reporting: Customizable client portals and reporting tools enable labs to offer tailored services to their clients and stakeholders.
Role-Based Onboarding Training:
Ovation LIMS offers tailored training modules for different laboratory roles, including Lab Techs, Accessioners, Report Reviewers, and Customer Support.
These modules include videos and articles to help users quickly get onboarded and proficient with the platform.
Workflow and User Guides:
Comprehensive workflow guides are available for various lab processes (e.g., COVID-19, serology, PGx, infectious disease), helping users understand step-by-step procedures.
Additional articles and resources are indexed for ongoing reference.
Hands-On Onboarding and Custom Training:
Ovation’s clinical laboratory experts provide custom onboarding and ongoing training to ensure labs are fully operational, typically within three weeks.
Training includes both initial onboarding and continuous education as workflows or features evolve.
Knowledge Base and Help Resources:
A searchable Knowledge Base offers detailed instructions, troubleshooting, and workflow documentation.
Users can access support resources directly from the dashboard, including a Help Beacon for real-time assistance and project requests.
Dedicated Customer Support:
Ovation provides dedicated customer support throughout implementation and beyond, ensuring labs have access to expertise whenever needed.
Ongoing personalized support is available for workflow changes, new test additions, or technical issues.
System and User Settings Guidance:
Articles and training cover user system requirements, account management, password resets, two-step verification, and other essential settings.
Document and Compliance Training:
Cloud Infrastructure & Physical Security:
Hosted on Amazon Web Services (AWS), which provides 24/7 infrastructure monitoring and meets stringent security certifications such as HIPAA/HITECH, ISO 27001, ISO 27018, and SOC 1, 2, and 31.
Data centers are distributed across multiple, physically separate availability zones, each with independent power, cooling, and physical security.
Data Encryption
All customer data is encrypted both at rest and in transit using industry best practices.
Data is stored in AWS RDS (for structured data) and S3 (for documents), both of which offer robust encryption and redundancy.
Access Control & Authentication
Role-based access control (RBAC) allows granular permissions to restrict data and system access to authorized users only.
Secure user authentication is enforced, with options for two-factor authentication (2FA) and SAML-based Single Sign-On (SSO)
Session management features automatically lock out users after 60 minutes of inactivity.
Audit Trails & Electronic Signatures
Comprehensive audit trails record all data-modifying operations, including user identity, timestamps, and changes made.
Electronic signatures are linked to reports and cannot be altered once committed, supporting regulatory compliance (e.g., 21 CFR Part 11).
Data Integrity, Backup, & Recovery
Nightly automated backups of structured data (RDS) and redundant storage for documents (S3), with document version retention.
Data is only stored in the U.S., and disaster recovery protocols are in place to ensure timely restoration in case of failure.
Compliance & Regulatory Adherence
Ovation LIMS is HIPAA compliant and designed to support other regulatory frameworks such as CLIA, CAP, and 21 CFR Part.
The system helps labs meet privacy and security requirements for personal health information (PHI).
User Activity Monitoring
All access and actions are logged for review, supporting internal audits and external regulatory inspections.
Continuous Updates & Support
Ovation LIMS releases maintenance updates everyweek. Recent update logs show consistent releases every week, including specific dates such as May 11, May 4, April 27, April 20, and so on, indicating a regular cadence of improvements and fixes.
Release Notes and Communication
Each update is accompanied by detailed release notes, which outline new features, enhancements, bug fixes, and any changes to existing functionalities. Users are encouraged to review these notes to understand the scope and impact of each update.
Update Management Process
Updates are managed to ensure minimal disruption to laboratory operations. The process typically involves:
Testing updates in a sandbox or staging environment before deploying to production, allows labs to validate new features and ensure data integrity.
Providing training and updated documentation for users on any significant changes or new functionalities introduced by the updates.
Maintaining compliance with regulatory standards by ensuring that updates do not compromise system integrity or data security.
Integration and Configuration Enhancements:
Some updates focus on improving system integrations, offering enhanced dashboards and event logs for better monitoring and troubleshooting of data exchanges between Ovation LIMS and other platforms.
Ongoing Support:
Data Ownership
Customers retain responsibility and ownership of the data they enter into Ovation LIMS. The Terms of Service specify that the customer is responsible for ensuring the accuracy and completeness of their service data, and for acquiring all necessary consents and rights for Ovation to process this data.
Ovation grants customers a nonexclusive right to access and use the service and their data for internal business purposes, including clinical laboratory services.
Data Portability (Export/Download)
Ovation LIMS offers an export feature that enables organizations to export all their stored data, including after subscription termination.
The export process is initiated by an admin user and involves preparing a downloadable package of the organization's data. This package can include CSV files for structured data, documents, and audit records, with options to filter by date range and data category.
Ovation provides scripts (Python and NodeJS) and instructions to facilitate the download and extraction of data, ensuring organizations can retain and manage their data according to internal policies.
Requests to migrate data from legacy systems into Ovation LIMS are treated as separate projects with their own scope and work order, ensuring clarity and customization for each migration scenario.
Flexible, Usage-Based Pricing
Ovation LIMS uses a sample-based pricing model, so you only pay for what you use. This approach allows labs to scale up or down easily, with costs reflecting actual sample volume each month-ideal for both growing and fluctuating lab operations.
No Long-Term Obligations
There are no long-term contracts or upfront costs. Labs can adjust their usage as needed without being locked into expensive, rigid agreements. This makes it straightforward to expand or reduce operations in response to business changes.
Cloud-Based, Modern Infrastructure
Because Ovation LIMS is cloud-based, adding or removing users, tests, or workflow modules can be done quickly and remotely, without the need for new hardware or complex IT changes. This supports seamless scaling for both small and large labs.
Rapid Workflow Adjustments
Labs can add new lines of testing or change workflows rapidly. When organizational needs shift, Ovation’s team can help implement changes quickly- just contact support to adjust workflows or add new tests, with minimal disruption to ongoing operations.
Support for Growth and Contraction
Ovation partners with labs for ongoing support, ensuring transitions-whether scaling up or down-are managed smoothly. The system is designed to maximize efficiency and minimize downtime during changes.
Multi-Organization and High-Volume Support
After the Initial Term, the contract automatically converts to a month-to-month agreement unless otherwise specified.
Ovation may change service pricing at the end of the Initial or Renewal Term with 90 days’ advance written notice.
Cancellation by Customer:
Customers can cancel their subscription at any time:
At Renewal: Use continues until the next billing renewal date, then the subscription is canceled with no further charges.
Immediate Cancellation: The subscription is terminated immediately, and any remaining time until the renewal date is forfeited.
Account Deletion: The account (and all data) is deleted along with immediate cancellation.
No payment is charged if a trial account is canceled before converting to a paid subscription.
Cancellation by Organization Admin:
Organization Admins can cancel at renewal, cancel immediately, or delete the organization and account entirely. All organization members are removed and deactivated upon immediate cancellation or deletion.
Termination for Cause
Either party can terminate the agreement with 30 days’ notice if the other party materially breaches any terms. Immediate termination is possible in the case of nonpayment.
Upon termination, the customer is responsible for paying 70% of the service fees up to and including the last day services are provided.
End-of-Relationship Obligations
Upon conclusion of the relationship, customers must return all materials owned by Ovation to the company, unless otherwise agreed in writing.
Account Suspension or Termination by Ovation
Ovation may suspend or terminate accounts for violations of terms, nonpayment, or at its discretion, and will not be liable for any resulting loss.
Ovation will use commercially reasonable efforts to continue operating the service for a reasonable period (up to 6 months) after notice of suspension or termination, to allow customers to plan a transition.
Data Handling After Cancellation
Customers retain the ability to export their data after cancellation or termination, supporting data portability and business continuity.
SOC 2 Type 1 Certification
Ovation LIMS is certified for compliance with the Health Insurance Portability and Accountability Act (HIPAA), specifically the HIPAA Security Rule (45 CFR Sections 164.308-316). This ensures the protection of sensitive patient health information and demonstrates robust data security practices.
The platform is designed to help laboratories comply with CLIA regulations, including requirements for sample tracking, report formatting, result verification, and document management.
Ovation LIMS supports compliance with CAP accreditation standards, including audit trails, electronic signatures, workflow checks and balances, and secure system access.
The system provides features and documentation to help labs meet COLA standards for laboratory operations and reporting.
