UL is a trusted leader in safety science, providing a variety of certification, inspection, and testing services for businesses around the globe. Customers turn to UL to help them achieve safety, security, and sustainability goals in order to manage risk effectively and achieve regulatory compliance.

Note: This story was featured in the April 2021 edition of LABInsights and has been edited for clarity.

Denkavit recently expanded the functionality of its LIMS, adding options for inventory management, tracking consumption and ordering lab consumables. To facilitate these additions to an application the animal feed manufacturer has been using since 2014, Denkavit’s LIMS supplier adapted its existing inventory management template and added new, client-specific functionalities.

As you work through validating the length of time over which your pharmaceutical products retain their quality and potency, you need to be able to trust in the accuracy and reliability of your testing, data, and documentation. 

The core functionality of your LIMS should be trusted with executing stability management, while also integrating well with all the other processes handled by the LIMS. Stability management does not live in a silo in the real world; why should it live in a silo in laboratory processes?

The stability study is a critical part of pharmaceutical product development, to determine how quality is affected with time in different environmental conditions. The efficacy of stability testing relies on careful monitoring and documentation. Accuracy and precision are directly correlated with successful stability testing; the more data provided as part of stability testing, the more detailed the insights into long-term quality may be. If something were to go wrong, proper testing and documentation help pinpoint the source of the issue so that it may be adequately addressed.

A recent New York Times article highlighted the manufacturing, testing, and distribution processes for the Pfizer-BioNTech Covid-19 messenger RNA (mRNA) based vaccine.

The careful execution, integration, and optimization of multiple steps are critical to the vaccine's safety, effectiveness, and efficient delivery. Pfizer's multifaceted vaccine process takes 60 days from start to finish across numerous locations involving thousands of employees. More than half of this effort goes to quality testing, which must adhere to vaccine manufacturing regulatory requirements, including compliance with current Good Manufacturing Practices (cGMP).

Due to the health benefits of cannabis, the drug has now been legalized in many states. Understanding the impacts of changing regulation on cannabis laboratories is important for many organizations. Laboratories must work to stay on top of best practices and in compliance with those regulations. 

To sell a cannabis product, licensed growers must meet state safety standards and ever-evolving regulatory requirements. Some producers think they can conduct their own testing; however, the impact of failing audits can put them out of business. Therefore, growers and manufacturers of cannabis-related products should partner with a reputable cannabis testing laboratory.

Cannabis is a complex plant containing a group of chemicals known as cannabinoids. Cannabidiol is commonly referred to as CBD, while delta-9-tetrahydrocannabinol is referred to as THC.

Since the use of cannabis for medical and adult use purposes has been legalized in many states, regulatory testing ensures the potency of the drug to ensure consumer safety. Regulations require that every hemp plant, product, and derivative needs to be tracked through the supply chain. This ensures patients are receiving a legitimate product and keeps illicit products off the market.

Implementing a LIMS has emerged as a key strategy in ensuring quality in high throughput environmental monitoring labs. These facilities include applications ranging from pharmaceutical manufacturing to food and beverage production. From sampling detail, sample storage documentation through testing, as well as reporting and trending, LIMS facilitates a level of automation and detail that cannot be achieved through manual efforts. These benefits are amplified with the increased sample volumes that come with high throughput labs.

Laboratory operations are inherently expensive operations to develop and maintain, particularly in regulated industries. When operations are harmonized, the lab has the ability to leverage training, standard operating procedures (SOPs), instruments and infrastructure.

For many industries, environmental monitoring is a requirement. For example, pharma and biopharma companies require sterile production environments. Microprocessor manufacturers need to maintain environment purity. Food, beverage, and nutritional supplement producers need to maintain pathogen-free environments. 

All of these applications have the challenge of managing a high volume of samples and tests, often in complex scheduling requirements, to maintain their environmental monitoring programs.

WILMINGTON, Del.-- LabWare, Inc., recognized worldwide as the leader in enterprise laboratory automation software, today announced that it has dominated the Laboratory Software Category in G2's 2021 Spring Grid Reports.

There’s no doubt using paper for recording vital data is dangerous. In a paper-based laboratory environment, you will hear the question, “Has anyone seen my notebook?” 

When you rely on paper-based systems to record data, everything you write down must be kept safe to reference notes, retrieve data, and cross-check the results. This information is fraught with risk if that paper trail is lost.

As the adoption of laboratory information management systems (LIMS) continues to grow, laboratories of all sizes, budgets, and specialties are faced with the question of whether they should implement one for their teams. Though it may seem tempting to find specialized use cases—and there is certainly value to be found in comparing implementations within specific laboratory settings—there are some universal needs shared by all laboratories, which a LIMS can meet and fulfill.

With more people becoming regular consumers of cannabis-derived products, some business analysts estimate that the United States cannabis industry could exceed $100 billion in only four years. 

Ensuring the quality and safety of cannabis products is a top priority for cultivators, manufacturers, and distributors to build consumer trust and achieve regulatory compliance. A growing number of US states have enacted new regulations that require comprehensive testing of tetrahydrocannabinol (THC) and cannabidiol (CBD) products by state-accredited laboratories.

Laboratory automation for quality control (QC) teams helps elevate performance by saving time and effort. The laboratory enjoys better efficiency, with less re-testing, less repeated work, and faster reviews of processes. With more efficiency, more consistency—intrinsic to automation—and less human effort required for repetitive processes, there is improved accuracy and quality to be noted in laboratory results.

Key Performance Indicators (KPIs) are invaluable tools that measure a company’s effectiveness. Each KPI “measures the goals of the business against the actual, quantifiable data over a specified period.” Laboratory KPIs help your laboratory stay accountable toward the lab’s goals. KPIs should be specifically set and customized to each laboratory. For example, the lab manager may want to evaluate the number of completed tests, as well as see those still under processing. These indicators serve as an index of how well the lab is running at any time, based on its set standards.

Although all laboratories must comply with industry standards in order to produce valid results, the pharmaceutical laboratory’s quality control (QC) team must adhere to some of the most stringent standards. This team is responsible for ensuring the quality and purity of pharmaceutical ingredients and products, where there is no room for error.

We spend a lot of time focusing on SOPs and setting up laboratory equipment and software in order to facilitate maximum compliance. Given the levels of technical details and specific procedures that are essential to proper lab functioning, it makes sense to build systems to effectively share this information and reinforce best practices.

But the culture in which a laboratory operates is critical as well, because it can drive how receptive the team is to adherence. Effective laboratory management relies on a few simple principles and tools that work to tip the scales into optimal lab function.

The traditional role of a compounding pharmacy is to make specific drugs prescribed by medical doctors to meet the needs of an individual patient.

Prescription compounding has seen a resurgence in recent years because of the many benefits offering formulas tailored to patient needs. Many patients have found mass-produced drugs difficult to stomach, or are sensitive or allergic to dyes and preservatives in commercially produced medications. Although this is great for patient care, regulatory scrutiny is increasing to ensure the safety of these same patients.

Scientific industries are challenged to keep pace with global demands for safe and effective pharmaceuticals, chemicals, medical devices and other scientific advances.

Contract research organizations (CROs) have become progressively more common in meeting laboratory outsourcing needs. In fact, they are now critical collaborators in assuring safety and effectiveness in a variety of scientific developments and innovations.

Integrating technology into your laboratory is never a one-person decision. Key stakeholders have different perspectives in terms of what they need from technology depending on their individual needs. Even within a small laboratory, there are many people impacted by the implementation of a laboratory management system (LIMS).

In the next five years, the lab information management system (LIMS) market is projected to reach approximately $2.22 billion. One of the most consistent sectors of growth is the cloud-based LIMS segment, which continues to grow each year.

Implementing a LIMS is a critical way in helping laboratory facilities track samples from receipt through storage and usage. A LIMS can save lab staff time by automatically documenting more features about each sample than an individual could and provides resources for automating sample testing and batch control. It addresses human error by helping to avoid penalties with a trail of data that can withstand auditing to the most rigorous of industry standards.

Effective and successful lab managers are first and foremost dedicated to the scientific endeavors of their chosen industry. The prospect of providing innovative and well-researched products and services to the global community is undoubtedly gratifying and honorable.

In today’s highly competitive scientific market, it is essential that all deliverables be timely, within regulatory compliance, and within budget. To merge the necessities of scientific rigor, health and safety, and global competition, the choice of your laboratory information management system (LIMS) is critical.

There are a growing number of LIMS solutions available to laboratories. Selecting the best choice for a laboratory requires a careful evaluation of the potential solutions. Perhaps the most important variable in this process involves ensuring that the LIMS meets the critical needs of the lab, which in turn requires a measure of awareness on the part of laboratory management.

WILMINGTON, Del.-- LabWare, Inc., recognized worldwide as the leader in enterprise laboratory automation software, today announced the production release of LabWare 8.

Labs using manual or older systems might be putting their workflows and compliance costs under undue stress. Consider if your current system isn’t saving you money and time -- or perhaps, actually increasing your expenses. If it is costing you money and time, this presents an opportunity to find an updated lab management system software that can streamline processes and track data for increased efficiencies.

Before considering if it’s time to update your systems, here’s what you need to know to conduct a needs analysis of your current workflow and systems.

Regulators are ever increasing scrutiny into labs and testing environments, including pharmaceutical development, compounding pharmacies, and others, to enforce compliance with industry standards. Audit findings of noncompliance may result in consequences as severe as loss of accreditation or even termination. Implementing LIMS software can help resolve or even get ahead of noncompliance by automating laboratory processes and documentation.

Dealing with a global pandemic such as COVID-19 has forced laboratories to evaluate how to safely and efficiently conduct business. Whether your laboratory is faced with a widespread global event, an on-site emergency that shuts down your physical location, or you simply want to modernize your business, implementing a remote work plan is a must-have for your lab!

Failing a laboratory audit means that internal systems for training and compliance need improvement, and also likely means that the lab may see more intense scrutiny for the foreseeable future. 

Since an effective plan for improvement and its implementation must be assembled as quickly as possible while also maintaining the usual laboratory output, any prescribed changes must be rapidly mapped, automated, validated, and implemented. LIMS software can help resolve this need by providing already proven and validated laboratory workflows.

The way your lab is organized can make a dramatic difference in the cost-savings and efficiency that you are able to achieve, and never is that more important than in today's competitive environment.

There are hundreds or even thousands of moving parts and data points in a lab environment, making it vital to ensure you have the right tools in place to identify and place your resources. Gaining full visibility of  your workflow has never been more important, particularly as compliance requirements evolve and require greater control and transparency throughout your lab.

It's important to understand the advantages of a LIMS implementation and how it elevates the performance and efficiency of a laboratory. By automating adherence to best practices as well as introducing controlled sample and data management, laboratories can free up time and resources while also improving quality controls and laboratory performance measurement.

A Laboratory Information Management System (LIMS) is an application built around a centralized database of samples and any meta data, results, workflows, and instruments associated with them. This not only allows a laboratory to remain organized, but also facilitates efficiency, transparency and compliance.

With LabWare SaaS LIMS now available, we’re helping LIMS buyers determine if the rapid deployment and rich functionality of LabWare SaaS LIMS will be sufficient or if the customizability of traditional LabWare LIMS will be required to meet quality assurance and quality control testing needs.