Clinical Diagnostics LIMS Tailored to Your Lab Needs

A Secure Healthcare & Medical LIMS for Diagnostic Labs

An in-the-Cloud Medical Diagnostic Software to Comply with Regulatory Guidelines

Streamline and Automate Workflows Using CloudLIMS - A SaaS, LIMS for Clinical Diagnostic Labs

Clinical diagnostic laboratories are a primary source of medical and healthcare data and generate massive amounts of data on a daily basis. Clinical diagnostic data is crucial for disease prognosis and for providing personalized healthcare to patients. Clinical diagnostic laboratories face numerous challenges daily. These include securely managing biospecimens and patient consent, safeguarding sensitive patient data, managing clinical tests and their results, delivering test reports to patients and providers, and managing resources, such as personnel, instruments, and consumables, besides following best practices and regulatory guidelines such as HIPAA, EU GDPR, CLIA, ISO 15189:2022, etc.

A Schematic Representation of a Typical Clinical Testing Laboratory Workflow

CloudLIMS - An All-in-One Healthcare LIMS Software

CloudLIMS is a purpose-built, scalable, SaaS, in-the-cloud clinical diagnostic LIMS. It grows with your diagnostic laboratory by supporting your data management, automation, and regulatory requirements. With a cloud solution, the clinical diagnostic LIMS can be accessed anytime, anywhere, is easy to deploy, and enables clinical diagnostic laboratories to quickly automate without the need to invest in IT infrastructure or personnel.

CloudLIMS customers have realized benefits in the following ways:
  • Meet regulatory guidelines and standards such as CLIA, HIPAA, EU GDPR, 21 CFR Part 11, and ISO 15189:2022.
  • Generate custom test reports to comply with the FDA, CDC, and state reporting guidelines.
  • A self-serve cloud-based, HIPAA-compliant physician and patient portal to enable physicians and patients to place test requests and track their status in real-time, and securely download test reports from anywhere, anytime.
  • Maintain a read-only audit trail to automatically record laboratory activities with a date and time stamp.
  • Customizable forms to manage patient data specimens, diagnostic tests and their results, kits, freezer inventory, and specimen shipment.
  • Safeguard Protected Health Information (PHI) of patients by assigning role-based PHI access to authorized personnel only.
  • A flexible data model to seamlessly configure and accommodate specific workflow requirements avoiding costly customization.

Clinical Test Report

Seamlessly Follow CLIA, ISO 15189, and HIPAA Guidelines With Our Medical Lab Management Software

Anonymize the PHI of patients to protect sensitive data from unauthorized access by assigning role-based access to authorized personnel only.

Manage training and competency records of laboratory personnel and regularly monitor their performance for quality assurance. This helps laboratory managers assign tasks only to the person with the appropriate training, competency, and experience to perform the tasks efficiently.

LIMS for Diagnostics Labs

Manage records of analytical instruments, schedule instrument calibration, and perform preventive maintenance as defined by the instrument manufacturer or laboratory’s internal practices. CloudLIMS helps you maintain calibration and maintenance results and records of functional checks performed before use.

Medical Lab Management Software

Seamlessly manage documents, such as procedure manuals, instrument maintenance manuals, standard operating procedures (SOPs), validated standard test methods, drawings, and manuals, and enable their access to authorized personnel. You can send documents for periodic review and approval to authorized personnel and ensure that only the latest version of documents is accessible to all authorized personnel.

LIMS for Diagnostics

HIPAA-Compliant Patient Portal

CloudLIMS’s all-in-one HIPAA-compliant, secure, cloud-based patient portal enables COVID-19 diagnostic laboratories to offer direct-to-patient services. The seamless communication with patients allows for better customer service and minimizes turnaround time.

Medical Diagnostic Software

CloudLIMS - A Complete Clinical Diagnostics LIMS

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Manage Patients/Subjects

Seamlessly manage the Person Under Investigation (PUI) data, including their demographic details, informed consent, symptoms, clinical course, past medical history, and pre-existing medical conditions.

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Manage Specimens

Assign unique system-generated or user-defined IDs to specimens, manage specimen data, generate barcodes for specimens, scan barcodes to quickly import specimens in CloudLIMS, and print labels. You can import specimens or aliquots from a file, maintain a specimen Chain of Custody (CoC), and track each specimen throughout its life cycle.

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Manage Diagnostic Tests

Manage diagnostic tests and their results, maintain test CoC, validate test results, analyze trends based on test results, and generate professional custom test reports.

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Manage Workflows & Enforce SOPs

Configure workflow templates and streamline your laboratory workflows with ease. The personnel assigned to the first task in the workflow can commence it. After completing a step, it can be marked as complete so that the next step opens for the next person. The step can only be performed if the steps before it in the workflow (if any) are complete, enforcing the laboratory staff to follow established SOPs.

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Scale as You Go

CloudLIMS offers exceptional flexibility by eliminating upfront costs. With our system, implementation becomes a seamless process, allowing you to adapt and grow without the need for upfront investments.

Instrument & Software Integration

Clinical testing laboratories receive hundreds of samples and generate massive volumes of analytical data on a day-to-day basis. Manual transfer of data from instruments such as blood gas analyzers, RT-PCR, digital PCR, LC-MS, GC-MS, ICP-MS, ELISA, HPLC, Nano LC, and spectrophotometers, and software such as HIS, LIS, EMR, EHR, participant registries, advanced MD, and Quickbooks to a LIMS is error-prone and time-consuming. For effective management of growing data volumes and laboratory automation, instrument and software integration is indispensable. Instrument and software integration facilitates data transfer from analytical instruments and software to a LIMS, thereby eliminating chances of transcription errors and data redundancy, and ensuring data integrity. Furthermore, it helps in automating laboratory workflows, thereby saving time and resources, reducing turnaround times, and enhancing efficiency.

Diagnostics LIMS

How CloudLIMS’ Medical Diagnostic Software Supports Instrument and Software Integration?

CloudLIMS supports instrument and software integration in the following ways:

  • Instrument Integration: CSV/XLS is a standard output file type generated by most analytical instruments. The CSV file mapping enables data to be imported from multiple instruments into a LIMS. CloudLIMS periodically reads instrument-generated CSV files and maps the headers present in the files with the correct fields in CloudLIMS, thereby transferring the analytical data to CloudLIMS seamlessly.
  • Software Integration: CloudLIMS’ Rest API can be configured to support integration with third-party software such as EMR, EHR, LIS, Patient Registries, etc. CloudLIMS can be preconfigured to upload results to the electronic reporting system of CDC/CSTE/ FEMA and other e-reporting tools, thereby automating reporting of test results. Furthermore, it can be integrated with medical or clinical billing software to effectively manage revenue cycles and minimize billing errors, enhancing customer experience and transferring the analytical data to CloudLIMS seamlessly.

Follow Regulatory Compliance

CloudLIMS' Medical Lab Management Software Functionality

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Manage Kits

Manage and configure kits, design barcodes for kits, and print labels. You can set reminders to receive alerts if the current number of kits is less than the specified quantity, ensuring the timely ordering of kits. You can import kit records from a file or export kit records in PDF or MS Excel format.

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Manage Inventory

Manage laboratory inventory such as reagents, glassware, laboratory coats, gloves, and surgical masks, and import inventory records from a file. Furthermore, you can associate each inventory item with specimens, patient IDs, and diagnostic tests and edit multiple inventory records simultaneously.

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Manage Package & Shipment

Track all shipments right from the origin to the destination to avoid misplacing samples. You can assign a unique ID to each incoming and outgoing shipment, associate each shipment with samples, and then check in the incoming samples or remove the ones shipped out.

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Manage Services and Billing

Manage laboratory services such as specimen purchase, storage, and test requests, and create catalogs with defined pricing for each service or package your laboratory offers. You can also generate invoices or upload the invoices generated using any third-party billing software should you choose not to use the invoicing function in CloudLIMS.

How CloudLIMS Supports COVID-19 Testing Workflows

CloudLIMS has helped multiple coronavirus testing labs get up and running in less than a week using FDA-approved, preconfigured workflows. CloudLIMS is preconfigured with COVID-19-specific tests, such as RT-PCR, serological tests for the detection of IgG/IgM antibodies, Enzyme-linked Immunosorbent Assay (ELISA), neutralization test, and Rapid Diagnostic Test (RDT). Furthermore, it is configured with COVID-19 and other infectious disease workflows and reporting templates for quick reporting of test results. 

CloudLIMS can be easily configured to support new test methods, assays, and reporting requirements, including those of the FDA and CDC, avoiding time-consuming customization. The preconfiguration helps minimize onboarding time and enables laboratories to go live within just a couple of days. CloudLIMS can be accessed anytime, anywhere, is easy to deploy, and enables COVID-19 diagnostic laboratories to quickly automate without the need to invest in IT infrastructure or personnel.

What Our Customers Say About Us

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Case Studies

Plusvital Streamlines and Automates COVID-19 Testing Workflows Using CloudLIMS

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Webinar

Laboratory Diagnosis of Monkeypox Virus: Current and Upcoming Tests

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Presentation

Setting up a Coronavirus (COVID-19) Clinical Diagnostic Testing Lab? LIMS for Automation and Data Management

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eBook

A Comprehensive Guide to Regulatory Compliance for COVID-19 Testing Laboratories

Scientific Advisor

Dr. Carolyn Compton

Professor of Life Sciences, Arizona State University Carolyn Compton

Happy Customers

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Our Awards and Recognition

G2 Recognizes CloudLIMS as Easiest To Do Business With Small Business in Winter 2023
G2 Recognizes CloudLIMS as Easiest To Do Business With Small Business in Summer 2023
G2 Awards CloudLIMS as High Performer Small Business in Fall 2023
CloudLIMS has won the SoftwareSuggest Customers Choice Winter 2022 Award
CloudLIMS Capterra Reviews