Computer system validation (CSV) is a documented process which helps to ensure that both new and existing computer systems consistently fulfill their intended purpose and produce accurate and reliable data. Most regulatory agencies around the world require validation of computer systems to ensure product safety and effectiveness. The software implementation and development team typically conducts CSV processes on the system being installed/updated to eliminate any software bugs and make sure the system meets specifications.
LabWare’s Enterprise Laboratory Platform (ELP) provides a Laboratory Informatics Management System (LIMS) and an Electronic Laboratory Notebook (ELN) that function together as a single integrated solution with a common, shared database. The LabWare solution provides an extremely flexible platform based entirely on open standards that can be configured to meet nearly any business need.
As much of LabWare’s functionality is data and template driven, the design and configuration of the master data (static data objects that are agreed upon and shared across the enterprise) is the most important aspect of any LabWare system. For both the initial implementation and ongoing activities, master data configuration has a dramatic impact on scalability and system maintenance activities. In this blog, we present a number of tips for master data configuration that will help to keep the core of your implementation solid and help to ensure that the system delivers a superior return on investment (ROI) over its lifetime for your organization.
Living a healthy and balanced live in today’s world is becoming more of a challenge. The human nature for growth, success, and profit don’t always go hand-in-hand with a sustainable eco-friendly environment. The latest industrial revolution has left traces from which the world has yet to recover. In the end, it is the air we breathe, the water we drink, and the food we eat that makes up the environment we live in.
It is therefore paramount to provide safeguards against the deterioration of water, mitigate air pollution, and setup prevention of natural resource depletion. Governments and international organizations have already set up policies, regulations, and guidelines in order to achieve more control of pollution and protect the health of the general population. These regulations have set certain baseline standards but tend to become more strict as research discovers more distinct safety levels.
Laboratory Information Management Systems (LIMS) are an important part of any modern laboratory. It is vitally important that any LIMS in operation function properly and reliably to ensure both data integrity and regulatory compliance. As such, a thorough computer system validation (CSV) plan should be developed and executed as part of any LIMS implementation project to confirm that the system is functioning as expected.
For today’s scientific organizations, a laboratory information management system (LIMS) is necessary tool for effective data management in the laboratory. For many reasons, companies often find themselves in a situation where it is advantageous to upgrade the laboratory environment by migrating data from legacy systems into a new or even existing LIMS. A LIMS data migration project will often involve the use of ETL technology to assist.
Migrating data to a LIMS can be a challenging endeavor, however. Companies often have years of historical data and knowledge stored in their existing LIMS that must be migrated over to the chosen system. Depending on the amount and complexity of the data sources in the legacy system(s), as well as the complexity of the new LIMS, the data migration can require much time and labor. Unless the project team does proper planning and execution, the migration process can end up being the cause of major project delays.
LabWare LIMS is an industry leading laboratory informatics system that combines the typically separate domains of a Laboratory Informatics Management System (LIMS) and an Electronic Laboratory Notebook (ELN) into a single application environment with a common, shared database. Upgrading LabWare and properly maintaining the solution streamlines laboratory management and automation with a flexible platform that can deliver a superior return on investment (ROI) for your organization.
In order to maximize ROI on your LabWare LIMS, it is critical to create a strategy to accomplish system maintenance and upgrades in an efficient and effective manner once the system is implemented. In this blog, we will discuss recommendations for developing a LabWare maintenance and upgrade strategy that will help your organization ensure compliance and reduce the overall cost of ownership of your LabWare LIMS.
In today’s highly competitive global economy, innovation is mission critical for research and development (R&D) organizations. An important key to effective innovation is the efficient capture and sharing of experimental data to help organizations leverage their collective experience and knowledge.
Understanding the role DNA plays in living creatures was the trigger for incredible scientific development that furthered analysis and interaction with life’s blueprint to help improve the human condition. Decoding the genomic sequence of single individuals allows detection of personal disease risk factors and the development of personalized treatment . High throughput sequencing techniques are increasingly in demand and Next Generation Sequencing (NGS)is the latest achievement in this field .
CloudLIMS, an advanced cloud-based SaaS LIMS, accelerates biobanking, clinical research, and testing laboratory operations by efficiently managing laboratory data on a cloud platform, enabling laboratories and their clients to access data in real-time, saving resources and reducing turnaround times. CloudLIMS version 1.73 is packed with new features and enhancements to prep testing and clinical laboratories to meet their data managing requirements.
When implementing a new LIMS, the question is not usually whether to migrate legacy system data, but how much data, in what manner, and why?
Any entity that stores biological samples can be called a Biobank. However, the term ‘Biobank’ is most commonly used for entities that store biological specimens on a large scale to provide them as a service for internal or external entities like researchers. Biobanks have to offer unbiased and high-quality samples using well-designed and documented procedures. This ensures a biological specimen is kept in a controlled environment and guarantees the ethical aspect of sample collection.
FDA Guidance for Good Clinical Practice (GCP) is an international quality standard defined by the International Council for Harmonization (ICH) that governs ethical and scientific considerations for designing, conducting, recording and reporting trials involving human subjects. Compliance with FDA Guidance for GCP in clinical trials helps to assure that the rights, well-being and safety of trial participants are protected and that the data generated in the trial is credible.
Due to the complex processes and technologies utilized in labs, and the many different aspects of the enterprise that laboratory systems touch, success in laboratory information management system (LIMS) projects can be difficult to achieve.
One of the biggest challenges for laboratories is to find a way of directly and easily communicating with their customers through a secure digital channel. An easy communication channel often leads to a hassle-free experience for the laboratory and a happy customer for them. For better laboratory operations and efficient customer service, several LIMS vendors introduced a client portal.
Due to technological advances in laboratory instruments and higher throughput processes, data volumes in modern analytical laboratories have increased dramatically over the last several decades. While this increased data volume presents the opportunity to improve innovation and enable timely and effective business decisions, it also presents significant data management and processing challenges. In order to meet the challenge of turning this data into knowledge, laboratories are looking to automate and integrate laboratory operations and processes as much as possible in order to provide digital continuity throughout the product lifecycle.
June 6, 2018 - American Whistleblower, Test America, Hunters Point Shipyard Cover-up and Michael Madry
A major cover-up of the Hunters Point shipyard was the falsification of asbestos tests by Test America formerly owned by H.I.G. Capital whose owners were also bundling money to Hillary Clinton. They fired Test America Quality Assurance Manager Michael Madry who blew the whistle.
We are back from the 2018 ASCO Annual Meeting, held in McCormick Place, Chicago, United States. Over 39,000 oncology professionals gathered from across the globe to discuss modern treatment methods, new therapies, and current controversies in the field of oncology.
CloudLIMS is back from ISBER 2018 Annual Meeting & Exhibits. This year, we were a bronze sponsor of the annual meeting where more than 700 delegates participated to discuss and advance biobanking and biospecimen research, in addition to global research. T
CloudLIMS, an advanced cloud-based SaaS LIMS, accelerates biobanking, clinical research, and testing laboratory operations by efficiently managing laboratory data and automating laboratory workflows on a cloud platform.