On June 27th, 2017, a massive ransomware attack infiltrated computer systems and locked up files (via encryption) at companies around the world and government ministries in Ukraine. Merck & Co. was among those affected. Merck employees arrived in their offices in the morning to find a ransomware note on their computers with hackers demanding payment to release critical files.
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.
Biotechnology research and development organizations are finding themselves under pressure from many directions:
- Business stakeholders want improved operational efficiency, scalability, and agility, while keeping costs under control.
- Regulators are raising the standards and scrutiny of informatics systems demanding strong demonstrable control of data integrity through the entire lifecycle of laboratory data.
- Vendors of laboratory informatics systems traditionally labelled as LIMS, ELN, LES, LIS, SDMS, CDS are blurring the definitions of their systems as they add capabilities to increase their sales: all vendors are claiming to be able to solve all problems.
All while the volume of data generated and processed in scientific laboratories continues to increase dramatically and the pressure for data to make decisions grows. Scientists and their R&D organizations want improved data management practices and increased operational efficiency: an integrated laboratory informatics infrastructure that goes beyond the vendor acronyms and delivers digitized scientific processes.
What do you call success? When it comes to a laboratory informatics implementation, the answer often depends on your perspective. A vendor may define success as getting the product into the production environment. A project manager might define success as an on-time, in scope, and on-budget delivery. And though both are common criteria for defining project success, on their own they are insufficient.
LabWare’s Enterprise Laboratory Platform (ELP) is a leading laboratory informatics system that is utilized by over 1,000 customers – everything from small companies to global enterprises – worldwide. ELP provides a comprehensive laboratory solution 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. The LabWare solution offers the benefits of both a LIMS and an ELN in a single platform that is both stable and supportable, without the IT complexity, expense and validation requirements of a customized interface layer.
Companies that use chemicals in a lab or their manufacturing process need to effectively manage those chemicals to control costs and enhance safety. Companies in regulated industries also need to comply with numerous federal, state and local regulations covering chemical purchase, use, transportation, storage, emergency planning and disposal. Given the ever-present risk of inspection by either regulatory agencies or regulated customers, it is essential for regulated companies to create an effective system for maintaining safety information and up-to-date inventories for chemicals.
CloudLIMS hosted a complimentary webinar titled “Data Privacy and Other Clinical Data Management Challenges”. The webinar was presented by Marianne Henderson, Senior Advisor on biobanking to the National Cancer Institute’s (NCI) Center for Global Health and the Senior Advisor for Division Resources, Division of Cancer Epidemiology and Genetics (DCEG). We received an overwhelming response from the audience and got asked a number of interesting questions.
To read the complete blog, please visit: https://cloudlims.com/blog/webinar-highlights-data-privacy-and-other-clinical-data-management-challenges.html
Data integrity is a hot topic as we move into 2019 and for good reason. Pharma and biotech companies produce an enormous amount of experimental R&D data. The sheer volume and complexity of the data makes managing this critical asset challenging. Leading companies are thus investing heavily in initiatives aimed at more effectively managing experimental data across its full lifecycle in hopes of driving the innovation necessary to stay competitive and ensure data integrity.
IT projects are notorious for high failure rates. Cloud portfolio management provider Innotas recently conducted a survey in which half of the businesses responding reported an IT project failure within the previous 12 months. Due to a wide range of factors, a successful laboratory information management system (LIMS) project can be particularly difficult to achieve.
“To be [paperless], or not to be, that is the question.”(Hamlet, Act III Scene 1)
Or at least it used to be the question. Today many labs are finding themselves obligated to move away from using paper in the lab, either for productivity enhancement purposes or just from the need to more easily adhere to regulations that apply to them. If you are working in one of the labs that is still clinging to a ton of paper and has not turned on the servers and gone electronic, the task of reducing paper is not as daunting as it sounds. Many organizations decide to take baby steps when addressing their paper reduction goals while others throw the whole kit and caboodle in and go entirely paperless all at once. But either way you decide, the most important part is starting the discussion.
CloudLIMS, an advanced purpose-built cloud-based SaaS LIMS, accelerates biobanking, clinical research, and testing laboratory operations by efficiently managing laboratory data, automating laboratory workflows, and following regulatory compliance on a cloud platform. The new version of CloudLIMS, version 1.80, is equipped with a new module, Instrument Calibration & Maintenance, to electronically manage all laboratory instrument records along with their previous and current calibration and maintenance data for audits.
Introduction: Clinical research is an important tool for drug discovery, personalized medicine, and patient-centered health care. The workflow in a clinical laboratory is tedious, tasked with a myriad of responsibilities and safety checks. A typical workflow initiates with the ordering of tests and specimen collection followed by proper labeling, storage and testing of the patient specimen.
In traditional medical care, diseases are typically detected via chemical changes associated with a particular condition and all patients receive a similar dose of a medication as treatment. While this one-size-fits-all approach has led to great advancements in medicine, it has by no means been successful for all patients.
With the successful completion of the Human Genome Project on April 14, 2003, the mapping of the human genome took approximately 13 years and 3 billion dollars to accomplish. Today, next-generation sequencing (NGS) technology allows a human genome to be sequenced in just a few days for a few hundred dollars.
While genomic research is paving the way for significant advances in healthcare, its practice has led to new challenges for biotechnology firms in terms of increasing data volume, variety and complexity.Given that the data representing a single human genome takes up to 100 gigabytes of storage space, biotech companies engaged in genomic research must develop the computing infrastructure and skills to manage, store, analyze and interpret massive quantities of highly complex data. In this blog, we will explore challenges and best practices involved in addressing data management challenges in genomics research.
The topic of the “cost of LIMS” or the “true cost of LIMS” or “saving costs with LIMS”, have all been previously discussed in a number of forums and mediums (blogs, white papers, webinars, videos, etc.). Interestingly, these discussions tend to focus on hard costs and measurable cost savings with only the occasional reference to non-monetary costs or qualitative measures. What has not been fully explored is the converse of this concept of the cost of implementing a Laboratory Information Management System (LIMS). That is, what is the cost of notimplementing a LIMS in a lab organization?
Post-genomic era led to a generation of large volumes of data, making it necessary for laboratories to modernize their approach for managing and tracking data. As a result, an increasing trend is observed in laboratories to switch their laboratory operations from paper records to a technologically powerful and secure Laboratory Information Management System (LIMS).
Laboratory informatics projects can be extremely complex and costly. LIMS projects, for example, require large investments of money, resources and time – costing anywhere from hundreds of thousands to millions of dollars, while requiring hundreds to thousands of resource hours, to implement. Given the financial, regulatory and operational risk to your organization that a laboratory informatics project represents, it is imperative that you get the project right the first time.
One of the keys to a successful laboratory informatics project is the development of a comprehensive set of functional and technical requirements for the system in question. Properly developed requirements are critical to guide and inform many different aspects of a successful informatics project. Too often, companies fail to do the necessary work in this area and end up deploying a system that fails to realize the potential business benefits that served as motivation for the project in the first place.
Laboratory information management systems (LIMS) capabilities have expanded dramatically in recent years in order to better serve scientific laboratories. As LIMS technology has changed, so has the number of factors that need to be considered when choosing the best LIMS for your laboratory.
A variety of different architectures are now available for modern LIMS, and these different architectures determine the way LIMS are installed, managed and utilized. Key factors to consider when selecting a LIMS is the type of architecture that is best aligned with your business goals, as well as the standards your organization’s IT group has established for IT architecture.
Defining user requirements is not only one of the most important aspects of purchasing a LIMS but frequently one of the most challenging. If it is not dealt with in sufficient detail, it can impact the quoted costs and lead to complications and delays at the later stages of the project. Recognizing the importance of this, we have undertaken a number of user requirement workshops in recent months with prospective customers.
Modern scientific laboratories increasingly rely on computerized informatics systems (e.g., LIMS, ELN, CDS, etc.) to process and manage data. To ensure product safety and effectiveness, it is important for these systems to be validated in a process known as computer system validation (CSV) to confirm the accuracy and integrity of processed data.