cloudlims - Tumblr blog

[cloudlims]

CloudLIMS Announces Metrc Integration with its Cannabis LIMS in Rhode Island

Wilmington, Delaware – September 18, 2024 – CloudLIMS, a leading SOC 2 compliant and ISO 9001:2015 certified provider of a secure, configurable, and future-ready laboratory information management system (LIMS), is pleased to announce the seamless integration of its cannabis LIMS with Metrc, the state-mandated seed-to-sale tracking system in Rhode Island. This integration empowers cannabis testing laboratories to enhance regulatory compliance, automate result reporting, and streamline laboratory operations, ensuring adherence to the state’s regulatory requirements.

The Office of Cannabis Regulation (OCR) requires all cannabis licensees in Rhode Island to use Metrc for tracking cannabis products throughout their cultivation, manufacturing, transportation, testing, and sale. The integration ensures that cannabis testing labs can track and trace all samples from receipt to final disposition, minimizing compliance risks and ensuring a seamless flow of information between the lab and the state’s tracking system.

Advantages of CloudLIMS’ Integration with Metrc for Cannabis Testing Labs in Rhode Island:

Automated Data Management and Test Results Submission: This integration allows laboratories to automatically pull sample information from Metrc into CloudLIMS, including key details such as Metrc package tag IDs and strain data. Once testing is completed, laboratories can easily upload the results back to Metrc with minimal effort, simplifying the reporting process and ensuring timely and accurate regulatory compliance. This reduces the administrative burden and ensures Metrc records are kept precise and up-to-date, minimizing errors and saving valuable time.

Real-Time Sample Tracking: Laboratories can monitor the status of samples and test results in real-time, leading to improved visibility across processes. This transparency enhances communication with clients and regulatory authorities, ensuring smooth operations.

Efficient Reporting Process: The integration automates the generation of compliant Certificates of Analysis (CoAs), significantly cutting down the time needed to prepare and submit these reports. This efficiency ensures that CoAs are delivered promptly, enhancing laboratory productivity and performance.

Faster Turnaround Times (TAT): The integration streamlines the reporting process, helping cannabis testing labs expedite regulatory submissions, ensuring compliance, and preventing delays.

Simplified Auditing: The CloudLIMS-Metrc integration makes it easier to access and verify data during audits, providing a clear and transparent trail for regulators. This ease of data access contributes to smoother audits.

Scalable Solution: As the cannabis industry in Rhode Island continues to expand, the integrated solution is designed to scale effortlessly, accommodating increased data volumes and complexity while maintaining compliance and operational efficiency as labs grow.

“We are excited to offer CloudLIMS-Metrc integration to cannabis testing laboratories in Rhode Island,” said Arun Apte, CEO at CloudLIMS. “In an industry where compliance is critical, the integration helps cannabis testing labs meet the state reporting requirements. The integration increases digitization in the whole process, simplifying audits and compliance, and saving labs time and resources so they can focus on delivering accurate and timely test results,” he continued.

About CloudLIMS

CloudLIMS.com offers a SaaS LIMS Software with zero upfront cost. CloudLIMS is a purpose-built LIMS for cannabis and hemp testing and extraction labs. CloudLIMS offers complimentary services such as instrument integration, custom CoA templates, technical support and training, automatic product upgrades and hosting, integration with seed-to-sale software, and automatic data backups. CloudLIMS helps testing labs manage data, automate workflows, and follow regulatory compliance, including ISO/IEC 17025:2017, GMP, GLP, 21 CFR Part 11, audit trail, and local regulatory guidelines. CloudLIMS.com is a SOC 2-compliant and ISO 9001:2015-certified informatics company. For more information, please visit www.cloudlims.com.

Contact:

Mrinal Kanti Chatterjee CloudLIMS.com 302-789-0447 support@cloudlims.com 

[cloudlims]

Laboratory Software for Clinical Research : Enhance your clinical research with CloudLIMS. Manage data efficiently and streamline your laboratory workflows

[cloudlims]

Environmental Testing LIMS: Optimize your environmental testing processes with CloudLIMS. Achieve accurate results and seamless regulatory compliance."

[cloudlims]

LIMS for Food and Beverage Testing Labs

Streamline your food and beverage testing with CloudLIMS. Ensure compliance and enhance data management efficiency effortlessly

[cloudlims]

Blood Bank LIMS: Explore the key challenges and best practices in blood banking, and discover how a blood bank LIMS solution can enhance efficiency through automation

[cloudlims]

CloudLIMS Announces Metrc Integration with its Cannabis LIMS in Ohio

Wilmington, Delaware – Aug 14 2024 – CloudLIMS, a leading SOC 2 compliant and ISO 9001:2015 certified provider of a secure, state-of-the-art, future-ready laboratory information management system (LIMS), is proud to announce the successful integration of its cannabis LIMS with Metrc, the state-mandated cannabis tracking system in Ohio. This integration will ensure seamless compliance with state regulations and enhance operational efficiency for cannabis testing laboratories in Ohio.

Marijuana Enforcement Tracking and Compliance (Metrc) is a robust seed-to-sale tracking system that enables more than 20 U.S. states to regulate the cannabis industry by tracing cannabis through the supply chain, including cultivation, processing, testing, and sale. The Ohio Department of Commerce’s Division of Cannabis Control has mandated the use of Metrc for all cannabis businesses in the state, including cannabis testing laboratories.

Key Benefits of CloudLIMS’ Integration with Metrc for Cannabis Testing Labs:

Automated Sample Handling and Results Posting: With this integration, laboratories can automatically import sample data from Metrc into the LIMS, including details like Metrc package tag ID and strain information. After testing, CloudLIMS users can upload test results to Metrc with just a few clicks. This streamlines the reporting process, ensuring timely and accurate compliance with state regulations while reducing administrative tasks. The integration keeps records consistently accurate and up-to-date in Metrc, eliminating discrepancies and saving time.

Real-Time Tracking: Laboratories can track the status of samples and test results in real-time, benefitting from greater transparency and improved communication with clients and regulatory bodies.

Streamlined Reporting: Metrc integration automates the generation of compliant Certificates of Analysis (CoAs), significantly reducing the time required for testing laboratories. This efficient process ensures CoAs are submitted promptly, boosting overall operational efficiency.

Reduced TAT: The CloudLIMS and Metrc integration speeds up state regulatory reporting for cannabis testing laboratories, avoiding regulatory non-compliance. 

Easy Audits: The CloudLIMS-Metrc interface eases regulatory audits by making data access and verification straightforward. This transparency ensures a smooth audit process and enhances compliance readiness.

Scalability: CloudLIMS-Metrc integration is built to effortlessly scale with business expansion in the growing cannabis industry. This scalability supports larger data volumes and increased complexity, ensuring ongoing compliance and enabling growth.

“We are thrilled to offer this new powerful integration to cannabis testing laboratories in Ohio,” said Arun Apte, CEO at CloudLIMS. “Compliance is a critical aspect of the cannabis industry, and the integration with Metrc provides a seamless solution to ensure laboratories meet regulatory requirements while digitizing their operations. We look forward to expanding Metrc integration to more states soon,” he added.

About CloudLIMS

CloudLIMS.com offers a SaaS LIMS Software with zero upfront cost. CloudLIMS is a purpose-built LIMS for cannabis and hemp testing and extraction labs. CloudLIMS offers complimentary services such as instrument integration, custom CoA templates, technical support and training, automatic product upgrades and hosting, integration with seed-to-sale software, and automatic data backups. CloudLIMS helps testing labs manage data, automate workflows, and follow regulatory compliance, including ISO/IEC 17025:2017, GMP, GLP, 21 CFR Part 11, audit trail, and local regulatory guidelines. CloudLIMS.com is a SOC 2-compliant and ISO 9001:2015-certified informatics company. For more information, please visit www.cloudlims.com.

Contact:

Mrinal Kanti Chatterjee CloudLIMS.com 302-789-0447 support@cloudlims.com

[cloudlims]

Migración de datos LIMS: cómo emprender la jornada desde la planificación hasta la evaluación posterior a la migración

La migración de datos parece engañosamente simple: un proceso destinado a transferir datos de un sistema antiguo a uno nuevo. Cuando se realiza de manera adecuada, los laboratorios obtienen más valor de sus Sistemas de Gestión de Información de Laboratorio (LIMS) y sus datos. Sin embargo, la migración de datos LIMS puede resultar bastante compleja y riesgosa si no se ejecuta correctamente. La pérdida de datos, la complejidad de la conversión de formatos de datos, las preocupaciones sobre la seguridad de los datos, el aumento de los costos y otras fallas en la migración de datos de LIMS pueden amenazar la continuidad y eficiencia del negocio. Por lo tanto, comprender la complejidad y seguir los pasos precisos es crucial para garantizar una migración exitosa, que no solo preserve la integridad de los datos sino que también permita una mayor eficiencia operativa e innovación.

¿Qué es la migración de datos LIMS y por qué es necesaria?

La migración de datos se refiere al proceso de transferir datos de un sistema o ubicación a otro. Esto podría implicar mover datos de un LIMS antiguo a uno nuevo, actualizar a una versión más reciente del LIMS o consolidar datos de múltiples fuentes en un solo LIMS.

Una gran cantidad de factores justifican la necesidad de migrar datos LIMS. Principalmente, la necesidad de migración de datos surge de las actualizaciones o reemplazos de sistemas, para mejorar la eficiencia y la productividad del sistema. De manera similar, los cambios de proveedores pueden promover la migración, a medida que los laboratorios buscan proveedores que ofrezcan funciones mejoradas o un mejor soporte. La evolución de los requisitos regulatorios también puede requerir la migración de datos para evitar obstáculos en su cumplimiento. Además, a medida que las empresas se expanden, la centralización de datos se vuelve imperativa para optimizar las operaciones y facilitar la colaboración entre diferentes ubicaciones. La adopción de soluciones basadas en la nube no solo mejora la accesibilidad, sino que también permite la escalabilidad y la rentabilidad. Además, la demanda de informes y herramientas de análisis mejoradas promueve que los laboratorios busquen plataformas capaces de ofrecer información accesible a partir de bases de datos complejas. El desmantelamiento de los sistemas legado y las mejoras de seguridad impulsan aún más la necesidad de una migración de datos, a medida que los laboratorios se esfuerzan por mitigar los riesgos y fortalecer su infraestructura de datos contra las amenazas emergentes.

Figura 1: Pasos para una migración de datos LIMS exitosa (Figura cortesía de CloudLIMS)

Para ejecutar de manera exitosa la migración de datos, se deben seguir minuciosamente una serie de pasos y etapas.

Planificación

El primer paso crucial en un proyecto de migración de datos LIMS es la planificación. Comienza con la asignación de recursos esenciales dentro del laboratorio, asegurando que haya suficiente personal, experiencia e infraestructura técnica para respaldar el proceso de migración. Colaborar con un proveedor de LIMS confiable puede agilizar significativamente esta fase, ya que puede brindar orientación y la asignación de un gerente de proyecto dedicado para supervisar todo el proceso de migración. Durante la etapa de planificación, se deben abordar varios aspectos clave para garantizar un proceso de migración fluido y eficaz.

La alineación de las partes interesadas es primordial, ya que todas las partes involucradas en el proyecto tienen objetivos claramente definidos y alineados con el objetivo general de lograr una transición sin problemas. Esto implica identificar a los propietarios de los datos y formar equipos o grupos de trabajo especializados para gestionar aspectos específicos de la migración.

La evaluación de datos legado es otro aspecto crítico de la etapa de planificación que requiere una evaluación exhaustiva de los datos alojados en el sistema existente. Los laboratorios deben determinar qué datos son esenciales para la migración al nuevo sistema y si cierta información se puede archivar o almacenar, para agilizar el proceso de migración.

Evaluar si los datos son adecuados para el nuevo sistema es crucial, ya que garantiza que los datos destinados a la migración sean compatibles con la nueva plataforma LIMS y cumplan con los estándares de calidad necesarios.

El cumplimiento normativo es otro aspecto vital a abordar durante la etapa de planificación, garantizando el cumplimiento de estrictas normas de seguridad y calidad para mantener las acreditaciones y certificaciones.

Además, es esencial establecer un cronograma de migración claro que describa el plan propuesto para la migración e identifique estrategias para minimizar la interrupción de las operaciones del laboratorio. Esto implica una cuidadosa coordinación de las actividades para garantizar una transición fluida y al mismo tiempo mitigar el riesgo de interrupciones operativas.

Una decisión integral durante la etapa de planificación es la selección del tipo de migración. Existen tres métodos comunes de migración: en paralelo, incremental y el big-bang.

En una migración en paralelo, tanto el LIMS existente (legado) como el nuevo LIMS operan simultáneamente durante un período de prueba definido. Este método es ampliamente adoptado por los laboratorios debido a su capacidad para garantizar la coherencia y precisión del nuevo sistema. Sin embargo, es fundamental tener en cuenta que este enfoque puede requerir muchos recursos y ser complejo. Desplegar personal para dar soporte a dos sistemas puede generar gastos importantes. Sin embargo, los beneficios son notables, ya que este enfoque mejora la precisión del sistema. Además, tener el antiguo sistema disponible como referencia durante el período de transición ofrece tranquilidad y permite la verificación de datos cuando sea necesario.

En el método incremental, la migración de datos se produce gradualmente, a menudo en etapas en lugar de hacerlo todo a la vez. Este enfoque implica un proceso de migración paso a paso, que minimiza el riesgo de interrupciones y permite que las operaciones del laboratorio continúen sin interrupciones. Por ejemplo, en la fase inicial, se pueden abordar configuraciones del sistema, como los cálculos. Posteriormente, se puede abordar la integración de instrumentos en la segunda fase, seguida de la integración de software de terceros en la tercera fase. Al dividir el proceso de migración en etapas, los laboratorios pueden implementar sin problemas el nuevo sistema mientras mantienen las operaciones normales.

En una migración big-bang, los datos y la funcionalidad del laboratorio se transfieren del sistema existente al nuevo sistema en una operación única e integral. Esta transición ocurre en una sola vez, generalmente durante un período de transición predefinido. Si bien este método ofrece velocidad, se utiliza con menos frecuencia debido a sus inconvenientes, como un tiempo de inactividad significativo y la interrupción del servicio al cliente. Además, a medida que aumentan la complejidad y la cantidad de datos, implementar el enfoque del big bang se vuelve cada vez más desafiante.

2. Extracción de datos

El paso de extracción de datos es un paso importante en el proceso de migración de datos, que implica la extracción de datos del sistema LIMS existente en preparación para su transferencia a un nuevo LIMS o una versión actualizada del LIMS existente. Esta fase exige una evaluación integral para identificar los datos y registros que requieren ser migrados, incluida información diversa que va desde detalles de las muestras hasta resultados de pruebas y datos de instrumentos. Se evalúan detalladamente todos los datos que se van a transferir, lo que exige una auditoría exhaustiva de los datos de origen. Los laboratorios necesitan identificar el tipo de datos que tienen. Por ejemplo, transferir datos estructurados, organizados en tablas y columnas, suele ser un proceso sencillo, mientras que transferir datos no estructurados, como imágenes, es más desafiante. Es importante contar con un LIMS que pueda soportar la exportación de grandes volúmenes de datos de una forma sencilla y práctica. La extracción adecuada de datos sienta las bases para una transición fluida al nuevo sistema.

3. Transformación de datos

Figura 2: Un sistema eficiente de LIMS permite una transformación de datos sencilla a través de sus capacidades de mapeo de atributos.

4. Limpieza de datos

El paso de limpieza de datos del proceso de migración de datos es fundamental y tiene como objetivo mejorar la calidad y confiabilidad de los datos que se transferirán a un nuevo LIMS. Esta fase implica un análisis de conjuntos de datos, tablas y bases de datos para identificar y rectificar diversas anomalías, incluida información poco confiable, inexacta, duplicada u obsoleta. A través de una rigurosa detección y rectificación de errores, la limpieza de datos mitiga el riesgo de transferir errores e inexactitudes al nuevo sistema, salvaguardando la integridad de los datos. Las tareas clave dentro del proceso de limpieza de datos incluyen identificar y rectificar errores como discrepancias ortográficas, inexactitudes o información incompleta dentro del conjunto de datos. Además, es esencial eliminar datos duplicados y estandarizar formatos, unidades y estructuras de datos para alinearlos con las especificaciones del nuevo LIMS. Además, se realizan comprobaciones de integridad de datos y procedimientos de normalización para validar la coherencia de los datos y el cumplimiento de estándares predefinidos.

5. Validación de datos

El paso de validación de datos tiene como objetivo verificar la precisión, coherencia y exactitud de los datos transferidos del sistema antiguo al nuevo. Este riguroso proceso garantiza que los datos migrados estén libres de posibles errores y discrepancias. A través de procedimientos de validación sistemáticos, los datos se examinan para identificar cualquier anomalía o inconsistencia que pueda haber surgido durante el proceso de migración. Los aspectos clave de la validación de datos incluyen verificar la integridad y corrección de los datos transferidos, asegurando que toda la información esencial se haya transferido con precisión. Además, se realizan verificaciones de consistencia para determinar que los formatos, unidades y estructuras de datos se ajusten a los requisitos especificados del nuevo LIMS.

6. Carga de datos

El paso de carga de datos en el proceso de migración de datos marca la culminación de la jornada de migración de datos, donde las bases de datos, tablas o estructuras del nuevo LIMS se completan con los datos extraídos, transformados y validados de etapas anteriores de la migración. Esta fase representa el puente final entre el sistema antiguo y el nuevo. Mediante la ejecución de procedimientos de carga de datos, se preserva la integridad y precisión de los datos migrados, asegurando que el nuevo LIMS esté equipado con una base sólida de información confiable. Las consideraciones clave durante esta fase incluyen la optimización de los procesos de carga de datos para minimizar el tiempo de inactividad y la interrupción de las operaciones del laboratorio, así como la implementación de mecanismos para monitorear y verificar la integridad de los datos después de la carga.

7. Evaluación posterior a la migración

La evaluación posterior a la migración garantiza que los datos migrados se alineen con las expectativas, cumplan con estrictos estándares de calidad y faciliten el funcionamiento eficaz del nuevo LIMS. Esta fase crítica incluye un proceso de validación integral para asegurar el éxito de la migración, preservar la integridad de los datos de laboratorio y abordar rápidamente cualquier problema emergente encontrado u observado durante la transición. Un elemento central de esta evaluación es una verificación de los datos para verificar la integridad y precisión de todos los datos transferidos del sistema antiguo al nuevo. Posteriormente, se examina la funcionalidad del nuevo LIMS para confirmar su perfecto funcionamiento. Esto se hace con evaluaciones como pruebas de aceptación del usuario (UAT), monitoreo del rendimiento y validación de personalizaciones. Las configuraciones o modificaciones personalizadas se prueban especialmente para garantizar que mejoren la eficiencia del flujo de trabajo sin comprometer el rendimiento general del sistema. Una evaluación exhaustiva posterior a la migración infunde confianza en la confiabilidad y eficacia del nuevo LIMS de un laboratorio, lo que resulta en una mayor eficiencia operativa y productividad.

Conclusion

A medida que la tecnología continúa evolucionando, los laboratorios buscan soluciones LIMS más avanzadas para optimizar las operaciones e impulsar la innovación. La adopción de estos sistemas a menudo requiere un ejercicio de migración de datos para realizar la transición de plataformas legado a LIMS modernos con una gran variedad de funciones. Como se describe en los distintos pasos del proceso de migración de datos LIMS, desde la planificación hasta la evaluación posterior a la migración, es evidente que la migración de datos es una tarea compleja que exige una evaluación cuidadosa y una ejecución precisa. Cada etapa, ya sea la extracción, transformación, limpieza o validación de datos, desempeña un papel crucial para garantizar una transferencia de datos perfecta y al mismo tiempo preservar la integridad y la precisión. Además, el paso de evaluación posterior a la migración sirve como punto de control final, afirmando el éxito de la migración y validando la eficacia operativa del nuevo LIMS. Asimismo, cada paso en el proceso de migración de datos sirve como un componente vital, empoderando a los laboratorios en su viaje de digitalización hacia una mayor eficiencia, innovación y descubrimiento científico.

Acerca de CloudLIMS:

CloudLIMS.com es una empresa de informática con certificación ISO 9001:2015 y SOC 2. Su LIMS SAAS en la nube, CloudLIMS, ofrece una sólida seguridad de los datos, soporte técnico gratuito, integración de instrumentos, alojamiento y copias de seguridad de datos para ayudar a los biorepositorios, laboratorios de investigación, analíticos y de diagnóstico a gestionar datos, automatizar flujos de trabajo y seguir los estándares regulatorios como ISO/IEC 17025:2017, GLP, 21 CFR Parte 11, HIPAA, ISO 20387:2018, CLIA, ISO 15189:2012 e ISBER Best Practices sin costo inicial. Su misión es transformar digitalmente y empoderar laboratorios de todo el mundo para mejorar la calidad de vida.

Sobre el autor

Arun Apte, director ejecutivo de CloudLIMS

Arun Apte es un emprendedor y científico investigador de laboratorio especializado en bioinformática. Fundó CloudLIMS en 2014, llevando los beneficios de un LIMS SaaS al mercado de los laboratorios. Esto ha permitido que cientos de pequeños laboratorios, incluidos biorepositorios, laboratorios de diagnóstico e investigación clínica y laboratorios analíticos, como los de alimentos y bebidas, cannabis, ambientales, de agua y de materiales, obtengan la eficiencia de un LIMS que antes solo era asequible para los grandes laboratorios. Arun es orador invitado en conferencias en todo el mundo. Recientemente, fue orador invitado en la Cannabis Quality Conference 2023.

Antes de fundar CloudLIMS, fundó PREMIER Biosoft y forjó asociaciones estratégicas con Thermo, Agilent, SCIEX y otras empresas de instrumentos de espectrometría de masas. Apte tiene un B.A. en biología molecular y celular y biofísica de la Universidad de California en Berkeley. Ha publicado extensamente sobre bioinformática.

[cloudlims]

CloudLIMS Announces Metrc Integration with its Cannabis LIMS in Michigan

Wilmington, Delaware – July 16, 2024 – CloudLIMS, a leading SOC 2 compliant and ISO 9001:2015 certified lab informatics provider, is proud to announce its integration with Metrc, the most trusted and experienced provider of cannabis regulatory systems in the United States. CloudLIMS’ inclusion on Metrc’s validated integrators list for Michigan typifies CloudLIMS’ continued commitment to enhancing regulatory compliance and operational efficiency for cannabis testing laboratories.

METRC, which stands for Marijuana Enforcement Tracking and Compliance, is a seed-to-sale tracking system for the cannabis industry. It ensures compliance by labeling and monitoring plants, following their journey from growth through harvest, and overseeing their transformation into cannabis products ready for market. In Michigan, the Cannabis Regulatory Agency (CRA) has mandated the use of Metrc as the designated tracking system for all commercial cannabis operations, including cannabis testing labs.

CloudLIMS’ customers will enjoy the following benefits with the METRC interface:

Automated Sample Retrieval and Posting of Results: The integration allows laboratories to automatically retrieve sample information from Metrc directly into the Cannabis LIMS, along with details such as Metrc package tag ID, strain, and more. Upon completing the tests, CloudLIMS’ users can seamlessly post test results to Metrc in a few clicks. This ensures timely and accurate reporting, helping laboratories comply with the state regulatory requirements without additional administrative overhead. The integration maintains consistently accurate and up-to-date records in Metrc, eliminating discrepancies and saving valuable time for laboratory staff.

Streamlined Reporting: Integration with Metrc automates compliant CoA generation, saving time for testing laboratories. This streamlined process ensures the timely submission of CoAs, enhancing overall operational efficiency.

Reduced Turnaround Time: The integration of CloudLIMS and Metrc significantly accelerates the reporting process, which is crucial in the fast-paced cannabis industry. This capability enables laboratories to report product test results to state regulatory agencies on time, ensuring compliance and preventing regulatory pitfalls.

Simplified Audits: During regulatory audits, CloudLIMS’ interface to Metrc simplifies data access and verification, transforming audits into a smoother, less stressful experience. The interface provides transparent access to necessary information, ensuring compliance readiness.

Real-time Visibility: The integration provides real-time updates on sample status and test results, allowing laboratory personnel to stay informed and make timely decisions. This transparency enhances communication and coordination within the laboratory.

Scalability for Growth: CloudLIMS’ interface to Metrc is designed to scale seamlessly with business growth in the expanding cannabis sector. This scalability accommodates increased data volume and complexity, ensuring sustained compliance and supporting expansion.

How Does the CloudLIMS-Metrc Integration Work

CloudLIMS’ integration with Metrc automates state regulatory reporting through a series of seamless steps. 

Laboratories initiate the integration by securely connecting CloudLIMS with Metrc using CloudLIMS’ proprietary and secure REST API key.

As samples are submitted to Metrc, the LIMS begins fetching sample details, including package tag IDs, item names, categories, and more information, from Metrc utilizing the facility’s license. 

Laboratory personnel then proceed with sample processing and testing, adhering to standard operating procedures. 

Finally, upon completion of testing, test results are automatically logged into the LIMS with interoperable instruments, and seamlessly transmitted back to Metrc in a state-compliant format, ensuring accurate and efficient reporting.

“We are excited to bring this integration to cannabis testing labs in Michigan,” said Arun Apte, CEO of CloudLIMS. “It underscores our commitment to providing an advanced, automated solution for cannabis testing laboratories, ensuring they can meet stringent regulatory requirements efficiently. We eagerly anticipate announcing Metrc validation in additional states soon, broadening our support for cannabis testing labs across multiple states,” he added. 

About CloudLIMS

CloudLIMS.com offers a SaaS LIMS Software with zero upfront cost. CloudLIMS is a purpose-built LIMS for cannabis and hemp testing and extraction labs. CloudLIMS offers complimentary services such as instrument integration, custom CoA templates, technical support and training, automatic product upgrades and hosting, integration with seed-to-sale software, and automatic data backups. CloudLIMS helps testing labs manage data, automate workflows, and follow regulatory compliance, including ISO/IEC 17025:2017, GMP, GLP, 21 CFR Part 11, audit trail, and local regulatory guidelines. CloudLIMS.com is a SOC 2 compliant and ISO 9001:2015 certified informatics company. For more information, please visit www.cloudlims.com.

Contact:

Mrinal Kanti Chatterjee CloudLIMS.com 302-789-0447 support@cloudlims.com

[cloudlims]

Podcast: Demystifying Proficiency Testing for Cannabis Labs with LIMS

Tune in to our podcast featuring Morgan Keefer, Accreditation Officer II at A2LA, as she delineates the intricacies of proficiency testing and interlaboratory comparison for cannabis testing labs, and addresses many pertinent questions on the topic.

[cloudlims]

Download the infographic to learn about the key factors to consider when starting a cannabis extraction lab & how a laboratory software for CBD/THC laboratories automates and supports day-to-day operations.

[cloudlims]

Infographic: Factors to Consider When Setting up a Cannabis Extraction Lab

The cannabis industry is booming across the world. With strict regulations by state governments, cannabis extraction laboratories need to ensure quality control and perform safety testing. Setting up an extraction laboratory is an uphill task and requires careful consideration of several factors to maximize productivity, assure employee safety, minimize losses and operational hazards. A Cannabis LIMS helps automate laboratory workflows, streamlines in-house testing processes, and provides real-time access to laboratory data. Furthermore, it helps manage analytical instruments, staff training, SOPs and supports compliance with regulations.

Download the infographic to learn more.

Source: https://cloudlims.com/blog/infographic-follow-the-usda-new-hemp-testing-rules-with-a-lims.html

[cloudlims]

Download the infographic on the USDA's new hemp testing rules to learn how a Laboratory Information Management System (LIMS) can fast-track your lab's preparedness.

[cloudlims]

Infographic: USDA’s New Hemp Testing Rules

In 1937, the Marijuana Tax Act was enacted. This act effectively prohibited the production, sale, and use of cannabis in the United States. The Agricultural Act of 2014 (the 2014 Farm Bill) revived industrial hemp production through State pilot programs in the United States. In 2018, a new Farm Bill (Agricultural Improvement Act of 2018) came into effect. This act decriminalized hemp production at the federal level. The USDA introduced a Final Rule for hemp testing laboratories on January 19, 2021, that became effective from March 22, 2021. The infographic delineates some of the federal guidelines for hemp testing and how laboratories can follow them with ease.

Download the infographic to learn more.

Source: https://cloudlims.com/blog/infographic-follow-the-usda-new-hemp-testing-rules-with-a-lims.html

[cloudlims]

Overcome Challenges in Cancer Research & Improve Decision-Making Using a Cloud-Based Informatics Solution

The fight against cancer has remained a great challenge for patients, their families and physicians as well as oncology researchers due to the dynamic and versatile nature of the disease. To date, there are over 100 different types of cancer that have been identified and they affect different cells in the body. They include carcinomas, sarcomas, leukemias, myelomas, melanomas, and lymphomas among others. Consequently, oncology researchers are constantly dealing with an avalanche of data and metadata (e.g., omics data or radiology data), which require robust infrastructure to collect, manage and interpret. It becomes even more difficult when these data sets have to be shared across different teams while maintaining compliance and other industry standards.

Why is Cancer Research Important?

Cancer research involves the discovery of cancer biology and genetic diversity and translating this knowledge to improve cancer therapy. Often, this involves the use and reuse of data from disparate sources (databases and samples). It may be necessary to get this data on one streamlined platform to allow oncology researchers faster access to the data and also facilitate collaboration, compliance, and maximize the value of research. This helps shorten the time to diagnosis and treatment and expedite the entry of drugs into the market.

Cancer treatment, from diagnosis to treatment, is always a race against time.

Cancer research sites and institutions often have limited access to research staff, facilities, and study participants or samples. Therefore, it is necessary to form networks where data, knowledge and samples can be shared collaboratively which is often a massive undertaking that requires advanced technological solutions. Multiple technical interfaces (interoperability) have to come in place since the data is usually found in varying documentation systems and at different sites. Data privacy, in this case, can be easily compromised if adequate measures are not put in place. Hence, appropriate technological solutions for pseudonymization have to be created and integrated into existing workflows to support compliance as well as yield acceptable and reproducible research results. Modern IT solutions can be used to help cancer research laboratories to maximize the value of cancer research.

As much as IT solutions will not necessarily cure patients; advances in medical IT research will go a long way in accelerating cancer research and facilitate timely treatments and consequently improve patient outcomes. With all forms of cancer, time is always of the essence.

How can a LIMS Help with Cancer Research?

The prototypical nature of cancer research requires the processing and integration of datasets in a robust technological environment. An appropriate LIMS for Cancer Research should support the whole process from tissue and sample collection and annotation to data analysis and reporting. A LIMS helps to collate data from multiple sources and studies without data redundancy, providing researchers access to high-quality data for fast decision-making. A LIMS for cancer research also helps in automating and monitoring complex workflows and flags steps that deviate from defined SOPs.

A LIMS for cancer research should be flexible, adaptive, and compliant. It needs to be able to manage data flow across different disciplines and allow the researchers to easily share and receive data, metadata, and results with other researchers in real time.

Integrating a LIMS with the different instruments such as DNA sequencers, visual tools, and other software, such as EMR, EHR, pathology systems, statistical tools, will provide the oncologist with a holistic view of the cancer patient in a real-life situation.

Ensuring Compliance in Cancer Research

Compliance is a top priority for every cancer laboratory. The Health Insurance Portability and Accountability Act (HIPAA) regulates the use and sharing of protected health information such as data related to the operation of cancer registries and registry-supported cancer research.

The lab’s LIMS should support the HL7 standards for data exchange in the cancer research industry. It also helps with consent management and meeting HIPAA requirements for safeguarding patient privacy & IRB protocols for tissue acquisition and data sharing.

Conclusion

With the complexity of cancer research and treatment, researchers can easily get overwhelmed by the multiform data that they are required to process. Deciphering the significance or irrelevance of data and metadata and drawing conclusions from the generated data sets requires the support of an intelligent and automated LIMS software. Such a software offers broader insights that can easily be translated into therapy at a faster turnaround time.

A cloud-based LIMS that manages large datasets and facilitates data access, visualization, analysis, and transmission can be integrated with other systems to facilitate informed decision-making. A cloud solution, besides storing data, may be able to execute algorithms that can be used by other researchers to gain insights from data without needing deep technical knowledge. This data can be easily accessed from different sources and locations at any given time, thereby overcoming the time constraints which is a major challenge in cancer research. This, hopefully, will speed up the decision-making process, improve patient outcomes, and clinical care of patients.

Originally published at https://cloudlims.com.

[cloudlims]

A Step-by-Step Guide to Prepare for a Remote Food Safety Audit

Food & beverage companies must ensure that food safety standards are met consistently. Certifying bodies are facing challenges in performing onsite audits due to social distancing and travel barriers introduced in the wake of COVID-19. Auditing is important for food processing, manufacturing, or testing facilities and enables supply chain due diligence to maintain food safety standards. It enforces the implementation of stringent programs and enables companies to stay on track with safe, quality-driven operations to maintain certification.

With in-house audits becoming a challenge during this pandemic, the concept of remote auditing has become an accepted alternative to traditional onsite audits for many food and beverage companies. The Global Food Safety Institute (GFSI) approved remote audits in the wake of coronavirus and announced that it would support the use of information and communications technologies (ICT) during audits.

What Steps does a Remote Audit Include?

Remote auditing is quite similar to onsite audits. You need to equally prepare for a remote audit as you do for an in-house audit.

Overview:

Notify the certifying body about your requirements for a remote audit.

You should then conduct a self-assessment and provide detailed information about your company’s programs, facilities, and operational workflows to the auditors.

Based on the information provided, the auditors determine if the company’s records and procedures could be checked and validated remotely.

After a risk evaluation process, the auditors will approve or deny your request for a remote audit based on the feasibility to conduct a remote audit.

Once your request for a remote audit is approved, you can prepare for it. You must keep all necessary resources, documents, and reports ready before the audit. The video of the facility is made available via CCTV cameras and video recordings of the facilities. In a remote audit, all documents and recommendations of auditors are digitally shared via a secure portal.

Once the audit is successfully completed, you will receive the certification. The auditors may suggest an onsite audit later. So, you should prepare for the onsite audit in advance.

Is Your Company Ready for a Remote Audit?

Step-by-step planning is the key to success in a remote audit.

Make sure to identify all requirements of the audit team, such as the method of conferencing, and be well prepared in advance.

Gather documents, such as visitor’s policy, non-disclosure agreements, in advance that you may need to send to your auditors so that you have enough time to rectify any issues that may arise.

Depute your key personnel to monitor the entire remote auditing process. They should be available at all times, in-person or remotely, to answer any questions the auditors may have.

Digitize all necessary documents before time as you will have to share them with the auditors over an online portal.

Ensure fast and secure internet connection to avoid any interruption in the remote auditing process. Do a test run to ensure the smooth functioning of all systems.

How a LIMS Helps Ease a Remote Audit?

Auditing requires proper maintenance of documents including standard operating procedures (SOPs), records of non-conformities and corrective actions taken, and material safety data sheets (MSDS). All these documents should be maintained in an electronic format before a remote audit. For companies still relying on paper-based data management processes, conducting remote audits becomes impractical as they face various challenges including loss of documents and manual errors, such as missing time stamps.

A food and beverage industry laboratory software, also known as food LIMS, can help overcome all such challenges, allowing a smooth remote audit. A Food LIMS can help in the following ways:

Securely stores all documents digitally at a centralized location along with proper file names and tracks version history, eliminating the risk of document loss. This allows food manufacturers to easily locate and retrieve required documents, and share them with the auditors.

Helps manage and digitally store laboratory documents, such as manuals, SOPs, instrument calibration, and maintenance reports.

Maintains a read-only audit trail to track all laboratory activities along with a date and time stamp. A LIMS can generate a comprehensive audit report which can be requested by auditors anytime.

Manages quality control samples and their test results. Furthermore, a food and beverage industry laboratory software generates quality control charts and helps take corrective actions if required.

Maintains complete records of the staff including their educational qualifications. A LIMS can easily generate staff training and competency reports which can be requested by auditors.

Automation increases efficiency in the overall auditing process, minimizes errors, and also helps achieve regulatory compliance, such as ISO/IEC 17025, with ease.

Conclusion

Certifying bodies may conduct remote audits even after the pandemic is over as it provides numerous benefits over the traditional onsite audits. Remote audits are cost-effective as it cuts down travel costs. Digital reports are more secure and can be stored for a longer time for validation in the future. Remote audits may gain more prevalence in the future with advanced information and communication technologies. Also, automation through IoT (Internet of things) is likely to enhance and streamline remote auditing. A food and beverage industry laboratory software can help manufacturers and testing laboratories to digitize their record-keeping process, automate their operations, and participate in remote food safety audits seamlessly. Remote auditing helps food & beverage companies to maintain safety and quality standards even in challenging circumstances.

Originally published at https://cloudlims.com.

[cloudlims]

Learn what is a LIMS (Laboratory Information Management System), How does it work and the benefits of LIMS.

[cloudlims]

COVID-19 Vaccination Rollout: Is Your Lab Ready for Antibody Testing?

The demand for antibody or serological testing may increase significantly with the COVID-19 vaccination rollout across the globe. Is your laboratory ready?

Antibody testing, though not currently recommended to assess immunity after COVID-19 vaccination, will help in the following ways:

Determine prior exposure to the COVID-19 virus.

Assess immunity after COVID-19 vaccination.

Determine the efficacy of vaccine candidates in clinical trials.

Perform epidemiological studies to ascertain the protection in the population.

Identify a population that is no longer at the risk of getting infected directly (herd immunity).

On a global scale, antibody testing is vital for the management and surveillance of the virus. It will help determine the full scope of the disease, the efficacy of the vaccination efforts, and this, in turn, will help to rebuild public confidence.

To this end, highly accurate antibody testing is needed to support both clinical and public health decision-making, even as the government and organizations strive to devise safe return-to-work strategies.

The FDA recently approved antibody testing for COVID-19 to facilitate the safe return to work for people who are immune to a certain level from the disease. The immunity conferred may not be long-lasting and is subject to several factors such as mutation of the virus which may compromise one’s acquired immunity. However, antibody testing can guide governments on the necessary steps to take to curb the spread of the virus.

How Does the COVID-19 Antibody Test Work?

After a person is infected by the coronavirus, the patient’s body initiates an antibody response against the virus. Two different kinds of antibodies are produced: IgM antibodies which are produced in the first few weeks post-infection and later IgG antibodies which confer long-term immunity. Detection of IgM antibodies denotes a recent infection while that of IgG antibodies denotes a distant infection. The antibody test is done on a blood sample and may take up to two hours to be completed.

Serological testing can be either qualitative or quantitative. A qualitative test detects the presence of antibodies against the virus. A quantitative test detects the exact amount of antibodies that are present in blood circulation.

Types of Antibody Testing for COVID-19 Virus

There are two broad types of antibody tests for the COVID-19 virus: binding antibody detection tests and neutralizing antibody detection tests.

Neutralizing antibodies can predict protection from future infection. High-throughput antibody tests can accurately quantify neutralizing antibodies in an individual and provide highly specific information to determine risk versus safety protocols. Assaying the amounts of neutralizing antibodies in exposed or vaccinated individuals will guide public health strategies to determine the possible trajectory of the pandemic. Consequently, neutralizing antibody detection tests are the gold standard in the industry.

The Emerging Demand for Antibody Testing

The economic pressure due to the stringent measures instituted to combat the COVID-19 pandemic is approaching a breaking point. Consequently, governments are being forced to devise measures to restore normalcy, even as they ensure that the spread of the virus is still controlled. This is an intricate balancing act, and hence, there is an increased demand for antibody testing. It is probable that in the coming months, antibody tests that can specifically detect the antibodies induced by COVID-19 vaccines will receive authorization.

Is your laboratory ready for COVID-19 vaccine antibody testing?

The Role of COVID-19 Testing Laboratories

In the wake of the COVID-19 vaccination roll-out across the globe, COVID-19 testing laboratories must be ready to meet the antibody testing demand that is likely to increase in the near future.

COVID-19 testing laboratories receive a large number of specimens and test requests on a regular basis. They are required to manage a large number of samples, protect personal information, and provide accurate, timely, and reliable data consistently. With the increasing demand for antibody testing, they will need to drastically improve their processes while remaining compliant and ensuring accuracy and confidentiality.

The Role of a LIMS

A cloud-based Laboratory Information Management System (LIMS) can help COVID-19 testing laboratories to meet the increasing demand for antibody testing throughout the cycle: collecting and managing specimens, ensuring privacy and compliance, reporting accurate and reliable test results. A LIMS helps COVID-19 testing laboratories manage data, automate workflows, and generate custom test reports to comply with the FDA and CDC reporting guidelines while limiting manual errors.

Conclusion

COVID-19 diagnostic testing laboratories need to respond to changes to assays and workflows with the advent of new tests that receive emergency use authorization. They also need to be equipped with quickly turning around antibody testing results for the local authorities to make decisions about the spread, immunity, and administering boosters to ensure the safety of the population. A preconfigured, scalable, and in the cloud COVID-19 LIMS solution would help such laboratories quickly come up to speed with the testing and reporting requirement through automation and quick deployment.

Originally published at https://cloudlims.com.