August 6, 2019 - Why a Third-Party Informatics Consultant Should be Part of Your Cloud Strategy

Cloud computing is the 21^st century’s version of the industrial revolution. In the last decade, cloud computing and associated software as a service (SaaS) products have experienced massive growth and adoption. The enormous increase in computing power accessibility that cloud technologies provide are helping to fuel a revolution in innovation and worldwide economic growth. Entire industries are being transformed as the cloud spawns new apps, products and services that are changing the way we live, work and play.

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August 6, 2019 - Enhancing Drug Discovery with BIOVIA Pipeline Pilot

The chances for a drug candidate entering a preclinical trial to eventually pass the FDA approval stage and make it to market are exceptionally grim – only 1 in 5,000 successfully complete the journey. Additionally, the entire process of bringing a new drug to market takes roughly 12 years on average, while the US Department of Health and Human Services has estimatedthat it costs somewhere between $161 million and $2 billion to bring a new drug to market.

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July 31, 2019 - The Value of a Scientific Data Management System (SDMS)

Most laboratories can readily see the value in the deployment of Laboratory Information Management System (LIMS) or a Chromatography Data System (CDS), but what about a Scientific Data Management System (SDMS)? Many companies feel confident that instrument data from the laboratory is protected in each instrument system (CDS, UV, IR, Mass Spec., etc.) and then…

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July 17, 2019 - Benefits and Best Practices for LIMS Implementation in Cannabis Testing Labs

Cannabis (aka hemp or marijuana) is a wind-pollinating genus of flowering plants in the family Cannabaceae. This complex plant contains a group of chemicals known as cannabinoids, many of which have shown significant biological activity. Two cannabinoids in particular, cannabidiol (CBD) and delta-9-tetrahydrocannabinol (THC), have gained much recognition for their mental and physical effects when consumed. To date, over 100 different cannabinoids have been isolated from cannabis plants, and these compounds are generating significant interest in the pharmaceutical industry for potential drug and biologics production.  Cannabis Testing Labs must implement the right processes to keep pace with regulation and innovation.

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July 17, 2019 - Best Practices for Implementing Informatics Systems for R&D Collaborations

In today’s global economy, scientific organizations in many different industries are turning to collaboration with external partners to fuel their R&D pipelines with flexible networks of researchers. These external collaborations can take many forms – research institutes, industry and academic partners, contract research organizations (CROs), contract development and manufacturing organizations (CDMOs), external testing laboratories, consortia, etc. Many organizations combine numerous partners in diverse ways across multiple research projects. Even in simpler models, any collaboration with an external partner is typically not static, but evolves over time. Therefore, sponsoring organizations are often changing the business processes around the collaboration frequently and rapidly.

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July 17, 2019 - Ease Concerns About DSHEA Updates in Your Nutraceutical Lab With a LIMS

The U.S. Food and Drug Administration (FDA)recently announced plans to update theDietary Supplement Health and Education Act of 1994 (DSHEA). The potential DSHEA changes have prompted concerns about the business impacts of additional regulatory rigor. To be ahead of the competition when changes occur,nutraceutical manufacturers should consider implementing aLaboratory Information Management System (LIMS),which can addressmany of the concerns.Also, consider therisks related to notimplementing a LIMS: analyze the monetary, time, and opportunity costs of maintaining your status quo. Compliance is often easier and less expensive with a LIMS.Before we get in to the specifics, let’s look at the background of these regulatory changes.

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July 9, 2019 - How QLIMS supports the medicinal cannabis process

How QLIMS supports the medicinal cannabis process

As the cannabis testing industry grows more and more, so does the need for greater efficiency relating to results, reports, regulatory compliance and the many other aspects of data management. Here we will explain to you how our solution, QLIMS, supports companies involved in each part of the chain and the items that medicinal cannabis companies should consider when selecting a LIMS and software for quality control. [Read More]

June 26, 2019 - Unlocking the Power of Deep Learning in Drug Discovery

Drug discovery is a challenging endeavor. The first step – finding compounds with the desired medicinal effect on the target pathogens – has traditionally involved the automated high-throughput screening of large compound libraries to identify “hits” with biological activity. Once identified, promising compounds are put through a process called lead generation to evaluate criteria such as their dose-response curve, cellular efficacy, affinity towards the target, reactivity with other compounds, cytotoxicity, etc.

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June 26, 2019 - Simplifying Results Collection and Approval in Laboratories

Of all the functionality offered by modern LIMS, accurate acquisition and reporting of test results is a central requirement. There are essentially two ways to enter results data into the LIMS – manually or directly from the testing instruments. Entering results manually is clearly quite common, but offers the possibility for transcription errors, especially if the results are first written down in a notebook and then later typed into the LIMS. Direct integration of instrumentation into the LIMS eliminates this possibility and helps meet data integrity and validity requirements. This is particularly important in the pharmaceutical manufacturing industry, where data integrity is critical throughout the cGMP (Good Manufacturing Practice) data life cycle. Data integrity refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA).

June 26, 2019 - Achieving & Maintaining ISO 17025 Accreditation LIMS Suport

June 12, 2019 - Creating an Effective Validation Master Plan

The Food and Drug Administration (FDA) is tasked with protecting the public health by ensuring the safety, efficacy, and security of the nation’s food supply, human and veterinary drugs, biological products, medical devices, vaccines, and other products. In order to fulfill its mission, the FDA requires that all products under its domain meet guidelines outlined in current Good Manufacturing Practice (GMP) regulations. …

June 12, 2019 - Moving Your LIMS to the Cloud: What You Need to Know

Modern laboratories in all industries are under intense pressure to reduce costs and improve operational efficiency, while at the same time enhancing quality and maintaining regulatory compliance. Additionally, the rise of R&D externalization strategies and contract research organizations (CROs) in the pharmaceutical industry has resulted in labs collecting large amounts of data from multiple partners, leading to a significant increase in laboratory workflow complexity.

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June 4, 2019 - Enhanced Stability Testing with Matrix Gemini LIMS

Stability studies are used to assess the shelf life of a product by storing samples under controlled environmental conditions for defined lengths of time prior to testing. Stability studies may be accelerated or real time; which of these is appropriate depends on the product under test or applicable regulatory requirements.. Managing multiple studies can be complex and time consuming, however the Matrix Gemini Stability System simplifies the whole study management process. As one of the most complete and mature study management systems on the market, Matrix Gemini Stability continues to gain traction and market share. Its highly flexible graphical configuration tools make it easy to configure the system to each customer’s exact needs, while providing the flexibility for change as the customer’s requirements evolve yet at the same time maintaining the underlying stability functionality. Not only that, a new stability analytics capability has been introduced which includes a fully integrated charting module to provide early indications of shelf-life performance for each product, or batch of product, under test.

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May 22, 2019 - 5 Things to Document When Justifying a LIMS or ELN

As clients go through the process of getting approval for laboratory informatics purchases, CSols experts often field questions like, “How much does a LIMS cost?” or “Is an ELN worth the investment?” or “What is the ROI for LIMS?”

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May 15, 2019 - Data Integrity: The Importance of a Quality Culture

Verification of data integrity is a critical part of the FDA’s mission to ensure the safety, efficacy and quality of human and veterinary drugs, biological products, and medical devices. As such, the FDA’s expectation is that all data generated to support the quality of manufactured products is both reliable and accurate. Compliance violations involving data integrity have led to numerous regulatory actions by the FDA in recent years, including warning letters, import alerts, and consent decrees. In 2018 alone, the FDA issued 54 warning letters that had references to data integrity and data management deficiencies in pharmaceutical companies, 10 of which were in the United States. An analysis of 2018 warning letters by FDAzilla found that 45% of GMP-related warning letters issued to pharmaceutical companies based in the United States included a data integrity deficiency.

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