mLAB LIMS - Terms of Use

Last Updated: February 24, 2026

mLAB LIMS, A LABORATORY INFORMATION MANAGEMENT SYSTEM FOR MODERN LABORATORIES, IS PROVIDED TO YOU OR THE ENTITY THAT YOU REPRESENT (hereinafter "You" or "Your") BY MPLUS SYSTEMS (hereinafter "mLAB", "we", "us", or "our"), ACCORDING TO THE FOLLOWING TERMS AND CONDITIONS (hereinafter "Terms") IN ADDITION TO MPLUS SYSTEMS GENERAL TERMS OF SERVICE. USE OF mLAB LIMS SIGNIFIES YOUR ACCEPTANCE OF THESE TERMS AND THE GENERAL TERMS OF SERVICE. IF YOU DO NOT AGREE TO THESE TERMS, DO NOT PROCEED OR USE mLAB LIMS IN ANY MANNER.

The Service

mLAB LIMS offers a comprehensive laboratory information management system that helps laboratories manage their operations, track samples, maintain quality control, and ensure regulatory compliance more effectively. mLAB LIMS provides various features such as:

Sample Management: Track samples from receipt through processing, storage, and disposal
Test Management: Define and manage test protocols, parameters, and result calculations
Inventory Management: Track reagents, consumables, and equipment
Quality Control: Implement QC procedures, track control samples, and manage non-conformances
Regulatory Compliance: Maintain audit trails, electronic signatures, and compliance with various standards (ISO 15189, ISO 17025, GLP, CAP, CLIA)
Reporting and Analytics: Generate reports, certificates of analysis, and laboratory analytics
Integration: Connect with laboratory instruments, EHR systems, and other enterprise applications

Access to Other mLAB Services

Many mLAB services are integrated with mLAB LIMS. Your mLAB account will also allow you to access all mLAB services even if such mLAB services are not integrated with mLAB LIMS. Use of some of these mLAB services may require acceptance of terms of service specific to such mLAB services. You must read, understand, and accept the relevant terms before using the corresponding mLAB service.

Technical Support

We provide technical support to help diagnose and resolve any bugs or issues with the service. Support will be provided in accordance with the Service Level Agreements (SLAs) and the support plans the customer has subscribed to. For additional information, you can refer to our Support Policy available at https://www.mplussystems.com/support.

Customers are responsible for ensuring their users are adequately trained and possess the necessary skills to use the service. Our technical support services are limited to addressing issues related to the standard use of the service. mLAB is not responsible for providing support for:

Custom development or specific customizations
Validation of laboratory workflows or processes
Interpretation of laboratory results or data
Compliance with specific regulatory requirements unique to your laboratory
Integration with third-party systems not explicitly supported

Regulatory Compliance and Laboratory Certification

If you use mLAB LIMS in a regulated laboratory environment (including but not limited to clinical, pharmaceutical, food testing, or environmental testing laboratories), you must hold all required certifications and comply with all applicable laws, regulations, and industry guidelines. This includes, but is not limited to:

Good Laboratory Practice (GLP)
Clinical Laboratory Improvement Amendments (CLIA)
College of American Pathologists (CAP) requirements
FDA 21 CFR Part 11 (Electronic records and signatures)
EU Annex 11 (Computerized systems)
HIPAA
GDPR

You understand that mLAB provides tools and features to support compliance (such as audit trails, electronic signatures, and access controls), but we do not verify, certify, or take responsibility for your compliance with specific regulations. You assume full responsibility for:

Validating the system for its intended use in your laboratory
Establishing and documenting standard operating procedures
Training personnel on proper system use
Maintaining compliance with all applicable regulations
Responding to regulatory inspections or audits

You will indemnify and hold us harmless from any claims or liabilities arising from your failure to comply with applicable regulations or from any regulatory actions related to your use of mLAB LIMS.

Data Integrity and ALCOA+ Principles

mLAB LIMS is designed to support data integrity in accordance with ALCOA+ principles, which require that data be:

Attributable: Who performed an action and when
Legible: Permanently recorded and readable
Contemporaneous: Documented at the time of the activity
Original: Preserved in its original form or certified copy
Accurate: Free from errors and properly verified

Plus additional principles:

Complete: All data including any repeat or reanalysis
Consistent: Chronological sequencing of events
Enduring: Durable record throughout the record retention period
Available: Accessible for review and audit over the lifetime of the record

You acknowledge that while mLAB LIMS provides features to support ALCOA+ compliance, you are responsible for implementing procedures and practices that ensure data integrity within your laboratory.

Sample and Data Management

Sample Tracking

You are responsible for:

Properly labeling and identifying samples in the system
Ensuring chain of custody documentation is maintained
Defining appropriate retention and disposal schedules
Managing sample storage conditions and locations

Test Results

You acknowledge that:

You are solely responsible for the accuracy and validity of test results entered into or generated by the system
mLAB does not verify, validate, or endorse any test results
You must have appropriate quality control procedures in place
You are responsible for result reporting and interpretation

Data Retention

mLAB will retain your data in accordance with your subscription plan and applicable laws
You are responsible for exporting and archiving data as needed for long-term retention
Upon termination, you will have 30 days to export your data before permanent deletion

Restrictions on Use

In addition to all other applicable terms and conditions, you agree that you will:

Prohibited Activities

not use mLAB LIMS for any illegal purposes or in violation of any applicable local, state, national, or international laws
not use mLAB LIMS to process data from human subjects without appropriate ethical approval and informed consent where required
not use mLAB LIMS for any purpose that would violate HIPAA, GDPR, or other privacy regulations without implementing appropriate safeguards
not upload, store, or process any data that you do not have the legal right to process
not use mLAB LIMS to create, validate, or support any medical device without appropriate regulatory approval
not impersonate any person or entity or falsely state or misrepresent your affiliation with a person or entity
not interfere with or disrupt the integrity or performance of the service or third-party data contained therein
not attempt to gain unauthorized access to mLAB LIMS or its related systems or networks
not use the service to store or transmit malicious code, viruses, or other harmful components
not reverse engineer, decompile, disassemble, or otherwise attempt to discover the source code of mLAB LIMS

Laboratory-Specific Restrictions

not use mLAB LIMS for direct patient care without appropriate validation and regulatory approval
not use mLAB LIMS as the sole basis for clinical diagnosis without appropriate professional oversight
not process samples or data from emerging pathogens without appropriate biosafety approvals
not use mLAB LIMS to track controlled substances without appropriate licenses and security measures
not use mLAB LIMS in a manner that would violate the terms of your laboratory's accreditation or certification

Data Collection and Compliance

mLAB LIMS enables you to collect, analyze, and organize data about samples, tests, results, and laboratory operations. In certain jurisdictions, data collection and use may be subject to regulations that require you to provide notice to individuals or obtain their consent. You acknowledge and agree that it is solely your responsibility to comply with all applicable laws, including but not limited to:

HIPAA (US Health Insurance Portability and Accountability Act)
GDPR (EU General Data Protection Regulation)
PIPEDA (Canada Personal Information Protection and Electronic Documents Act)
LGPD (Brazil Lei Geral de Proteção de Dados)
CCPA/CPRA (California Consumer Privacy Act)
Other applicable privacy and data protection laws

mLAB is not responsible for your compliance with these regulations or for any legal obligations arising from your data collection and laboratory activities. You agree to:

Provide appropriate privacy notices to individuals whose data you process
Obtain necessary consents for data collection and processing
Implement appropriate security measures to protect data
Respond to data subject requests (access, correction, deletion, etc.)
Report data breaches as required by applicable law

Usage Limits for mLAB LIMS

mLAB may prescribe usage limits based on the subscription plan chosen by you, including but not limited to:

Maximum number of samples processed per month
Maximum number of users
Maximum storage capacity for results and attachments
API call limits
Concurrent session limits

You must ensure that your usage is within the usage limits prescribed by mLAB in order to avail uninterrupted service. You understand that mLAB may restrict or throttle activities if you reach the usage limit corresponding to such activity. Exceeding usage limits may result in:

Temporary suspension of certain features
Automatic upgrade to a higher-tier plan
Additional usage-based charges
Throttling of API requests

Instrument Integration

mLAB LIMS may provide integration capabilities with laboratory instruments and equipment.

Your Responsibilities

Ensure instruments are properly calibrated and maintained
Validate instrument integrations for your specific workflows
Verify that data transfer is accurate and complete
Maintain appropriate backup procedures for instrument data
Ensure instrument connectivity and network security

Limitations

mLAB is not responsible for instrument malfunctions or inaccuracies
Integration may not be available for all instrument models or manufacturers
Custom integrations may require additional development and validation
Real-time integration depends on instrument availability and network connectivity
mLAB may modify or discontinue support for certain instrument integrations with reasonable notice

Electronic Signatures and Audit Trails

If you use electronic signatures in mLAB LIMS:

Compliance with 21 CFR Part 11

mLAB LIMS provides features to support compliance with 21 CFR Part 11 and similar regulations, including:

Unique user IDs and secure passwords
Timestamped audit trails
Electronic signature manifestations
Signature meaning and linking to records

Your Responsibilities

Establish written policies and procedures for electronic signatures
Ensure that electronic signatures are legally binding equivalents of handwritten signatures
Maintain appropriate controls to prevent unauthorized use of signatures
Train users on the proper use of electronic signatures
Verify that audit trails are reviewed periodically
Retain audit trail data as required by applicable regulations

You acknowledge that electronic signatures used in mLAB LIMS are legally binding and you will not dispute the validity of records signed electronically through the system.

Validation and System Suitability

mLAB LIMS is developed following quality management practices, but you are responsible for validating the system for its intended use in your laboratory.

User Acceptance Testing

You agree to:

Conduct appropriate user acceptance testing before deploying mLAB LIMS in production
Document test protocols and results
Verify that the system meets your specific requirements
Test integrations with instruments and other systems
Validate calculations and report generation

Periodic Review

You agree to:

Periodically review system performance and suitability
Re-validate after significant updates or configuration changes
Monitor system logs and audit trails
Review and update risk assessments as needed

Business Continuity and Disaster Recovery

mLAB maintains business continuity and disaster recovery procedures to minimize service disruption.

Our Commitment

Regular backups of customer data
Redundant infrastructure to prevent single points of failure
Documented disaster recovery procedures
Regular testing of recovery capabilities

Your Responsibilities

Maintain local copies of critical data as needed
Develop your own business continuity plans
Test your ability to operate during service interruptions
Maintain offline procedures for critical laboratory operations
Ensure you can export data if needed

In the event of a disaster, we will make reasonable efforts to restore service, but we cannot guarantee that all data will be recoverable or that service will be restored within a specific timeframe.

Audit Rights

Regulatory Inspections

You may be subject to inspections by regulatory authorities (FDA, EMA, CAP, etc.). You agree to:

Provide inspectors with access to relevant system documentation
Demonstrate system functionality as requested
Provide audit trail and other records as required

mLAB Audit Support

mLAB will provide reasonable assistance during regulatory inspections, including:

Access to relevant system documentation
Technical explanations of system functionality
Confirmation of system controls and features

You acknowledge that you are responsible for the costs associated with regulatory inspections, including any fees for mLAB's audit support beyond standard customer support.

mLAB LIMS Embed Code and APIs

Embed Code

mLAB LIMS Embed Code is the code that may be installed on your website or internal applications for the purpose of integrating with mLAB LIMS ("Embed Code"). Subject to these Terms:

mLAB grants you a limited, revocable, non-exclusive, non-transferrable, non-sublicensable license to install, copy, and use the Embed Code solely as necessary for you to use mLAB LIMS
You will not (and you will not allow any third party to):
- Copy, modify, adapt, translate, or otherwise create derivative works of the Embed Code or documentation
- Reverse engineer, decompile, disassemble, or otherwise attempt to discover the source code of the Embed Code
- Rent, lease, sell, assign, or otherwise transfer rights in or to the Embed Code and documentation
- Remove any proprietary notices or labels on the Embed Code
- Use, post, transmit, or introduce any software that interferes with the operation of the Embed Code

APIs

mLAB may provide APIs for programmatic access to mLAB LIMS. Use of APIs is subject to:

API usage limits based on your subscription plan
Rate limiting to ensure service stability
Authentication and authorization requirements
Documentation and best practices

You agree to use APIs in a manner that does not:

Exceed reasonable request volumes
Disrupt service for other customers
Attempt to circumvent access controls
Access data you are not authorized to view

Violations

You understand and agree that mLAB may screen content or otherwise monitor your usage of mLAB LIMS to ascertain if you have used the service in violation of these Terms. If your use of mLAB LIMS is found to be in violation of these Terms, mLAB may, in its sole discretion, take appropriate actions against you, which may include:

Issuing a warning
Suspending access to certain features
Temporary suspension of your account
Permanent termination of your account
Reporting violations to appropriate regulatory authorities
Pursuing legal remedies

In the event of termination for violation of these Terms, you will not be entitled to any refunds and may be liable for damages caused by your violation.

Disclaimer of Warranties

mLAB LIMS IS PROVIDED "AS IS" AND "AS AVAILABLE" WITHOUT WARRANTY OF ANY KIND, EXPRESS OR IMPLIED. TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, mLAB DISCLAIMS ALL WARRANTIES, WHETHER EXPRESS, IMPLIED, STATUTORY, OR OTHERWISE, INCLUDING BUT NOT LIMITED TO:

IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, AND NON-INFRINGEMENT
WARRANTIES THAT THE SERVICE WILL MEET YOUR REQUIREMENTS OR EXPECTATIONS
WARRANTIES THAT THE SERVICE WILL BE UNINTERRUPTED, TIMELY, SECURE, OR ERROR-FREE
WARRANTIES THAT DEFECTS WILL BE CORRECTED
WARRANTIES REGARDING THE ACCURACY, RELIABILITY, OR COMPLETENESS OF ANY DATA OR RESULTS

NO ADVICE OR INFORMATION, WHETHER ORAL OR WRITTEN, OBTAINED BY YOU FROM mLAB OR THROUGH THE SERVICE SHALL CREATE ANY WARRANTY NOT EXPRESSLY STATED IN THESE TERMS.

Limitation of Liability

TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, IN NO EVENT SHALL mLAB BE LIABLE FOR ANY:

INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, OR PUNITIVE DAMAGES
LOSS OF PROFITS, REVENUE, DATA, USE, GOODWILL, OR OTHER INTANGIBLE LOSSES
DAMAGES RELATING TO LABORATORY RESULTS, PATIENT CARE DECISIONS, OR REGULATORY COMPLIANCE
COSTS OF PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES
DAMAGES ARISING FROM INSTRUMENT MALFUNCTIONS OR DATA TRANSMISSION ERRORS

WHETHER BASED ON WARRANTY, CONTRACT, TORT (INCLUDING NEGLIGENCE), STATUTE, OR ANY OTHER LEGAL THEORY, AND WHETHER OR NOT mLAB HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

mLAB'S TOTAL LIABILITY TO YOU ARISING OUT OF OR RELATED TO THESE TERMS OR YOUR USE OF mLAB LIMS SHALL NOT EXCEED THE AMOUNT PAID BY YOU DURING THE TWELVE (12) MONTHS IMMEDIATELY PRECEDING THE EVENT GIVING RISE TO LIABILITY.

Indemnification

You agree to indemnify, defend, and hold harmless mLAB, its affiliates, officers, directors, employees, and agents from and against any and all claims, liabilities, damages, losses, costs, expenses, and fees (including reasonable attorneys' fees) arising from or relating to:

Your use of mLAB LIMS in violation of these Terms
Your violation of any applicable law or regulation
Your violation of any third-party rights, including but not limited to intellectual property rights, privacy rights, or contractual rights
Any claims related to the accuracy, validity, or legality of test results or laboratory data
Any claims arising from patient care decisions based on data processed through mLAB LIMS
Any claims related to your failure to comply with regulatory requirements
Any claims related to your handling of controlled substances or regulated materials
Any disputes with regulatory authorities arising from your use of mLAB LIMS

mLAB reserves the right, at your expense, to assume the exclusive defense and control of any matter for which you are required to indemnify us, and you agree to cooperate with our defense of these claims.

Modification of Terms of Use

mLAB reserves the right to modify these Terms at any time. We will provide notice of material changes through:

Email notification to the registered account administrator
In-app notification upon login
Announcement on our website

Modifications to these Terms are effective upon your use of mLAB LIMS subsequent to publication of such modification, or as otherwise specified in the notice. If you do not agree to the modified Terms, you must stop using mLAB LIMS and terminate your account.

Your continued use of mLAB LIMS after the effective date of any modification constitutes your acceptance of the modified Terms.

Contact Information

For any questions regarding these Terms of Use, please contact:

mLAB LIMS Team Mplus Systems

For Technical Support: Email: support@mlablims.com Website: https://www.mlablims.com/lims

This document is for informational purposes only and does not constitute legal advice. mLAB LIMS is a product of Mplus Systems. Users should consult with their legal and regulatory affairs departments to ensure compliance with all applicable laws and regulations.

Last reviewed for regulatory compliance: February 24, 2026