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Enterprise-Grade Compliance & Security for Modern Labs

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Compliance Without Compromising Usability

Lockbox LIMS is deployed across a wide variety of laboratory environments globally, each with unique compliance requirements. Meeting these strict regulations requires a combination of robust processes, advanced systems, and reliable technology. Lockbox LIMS is the technical foundation to reach your compliance goals. Powered by world-class cloud infrastructure and backed by expert professional services, Lockbox LIMS is an effective tool to help meet all your specific regulatory, functional, and operational goals.

Data Privacy

Comply with local and global data privacy standards such as HIPAA, GDPR, CCPA, PIPEDA, and PDPA.

  • Select local data residency, including the USA, Canada, UK, EU, Switzerland, Singapore, and Australia.
  • Specify granular data permissions, sharing logic, and allowed functionality by role type, location, and seniority to provide privacy and security.
  • Anonymize/pseudonymize/deidentify patient data in production and testing environments.
  • Manage patient consent and sample destruction workflows.
  • Retain data indefinitely or configure time-based (e.g., 10 years) data retention and/or archiving rules.

21 CFR Part 11 / EU Annex 11

Comply with FDA 21 CFR Part 11 and EU Annex 11 standards.

  • Generate signed patient reports (including amendments, addenda, and corrections) with forced re-authentication or native DocuSign integration.
  • Track changes with an immutable Field Audit Trail.
  • Track training using our Training Management module.
  • Only allow trained users to Execute Protocols.

Enterprise-Grade Cloud Hosting

Lockbox LIMS is powered by Salesforce Hyperforce, leveraging the global scale and security of AWS.

  • ISO certified (including 9001, 22301, 27001, 27017, 27018, and 42001).
  • Audit compliant (including SOC 1, SOC 2, and SOC 3).
  • Second Level Compliant with EU Cloud Code of Conduct.
  • Use your existing Single Sign-On (SSO) provider or native Multi-Factor Authentication (MFA).
  • Encrypted platform, plus bring your own key for maximum encryption security.
  • Back up your data with fully integrated free or paid solutions.
  • Stay online with Hyperforce High Availability Architecture that stores data across at least three availability zones.
  • Seamlessly scale from startup to enterprise record volume without needing to upgrade servers.
  • Automatically require new passwords at specified intervals.

How does Lockbox Support Individual ISO Standards and Other Methodologies?

See Why LIMS Validation is Essential for Laboratory Success. 

See How Lockbox Can Help You Meet CAP/CLIA Regulatory Requirements. 

Lockbox LIMS provides the digital infrastructure to support your lab in achieving and retaining ISO 9001 certification. Audit Trails, Sample Tracking, and Electronic Signatures ensure data integrity and traceability. Built-in formulas and locked protocols in our Protocol Execution module provide consistent instructions and avoid human computational errors. Our QMS modules, Document Control, Training Management, Instrument Management, and Quality Events (including Deviations and CAPAs), round out our support for ISO 9001 customers.

See Ensuring Lab Standards: Meeting ISO 17025 Requirements with LIMS. 

Built for massive scale, Lockbox LIMS provides the end-to-end lineage tracking and robust storage hierarchy necessary for biobank compliance. The system supports compliant sample destruction by updating statuses and volumes to zero without deleting the historical records, and allows secure data migration for millions of legacy records. Since Lockbox LIMS is cloud-based, our database grows to accommodate your growing needs.

Learn more about our Advanced Biobanking LIMS Solutions.

The Lockbox LIMS managed package is fully verified by our QA team. Third Wave offers Vendor Verification and full support for your Validation process, supporting a full IQ/OQ/PQ. See Why LIMS Validation is Essential for Laboratory Success. 

Audit trails, traceability, and chain of custody are at the heart of Lockbox LIMS, ensuring that you can always see what records are related and what data has been changed. 

The Instrument Management and Protocol Execution modules track instrument calibration and maintenance, and ensure that instruments that aren’t ready to use are blocked. Quality Events Management and Document Control provide full on-platform QMS functionality directly linked to your samples, protocols, and instruments, allowing you to quickly see everything in one place.

For customers with Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), or other GxP certifications, Lockbox LIMS ensures traceability, accountability, and data integrity. The system features complete sample hierarchy tracking and visualization, and detailed audit trails. Furthermore, we utilize GAMP 5 methodology to verify and regression test every component of our managed package. Learn more: 6 Key Features of Lockbox LIMS for Data Integrity and Traceability. 

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Reports and Dashboards


Report on metrics captured throughout your sample workflow

Learn how Lockbox LIMS meets regulatory requirements today

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