BIOVIA Archives - Astrix https://astrixinc.com/tag/biovia/ Expert Services and Staffing for Science-Based Businesses Thu, 04 Apr 2024 00:16:39 +0000 en-US hourly 1 Enhancing Drug Discovery with BIOVIA Pipeline Pilot https://astrixinc.com/blog/enhancing-drug-discovery-with-biovia-pipeline-pilot/ Sun, 01 Jan 2023 20:11:52 +0000 http://localhost/astrix/?p=3033 The chances for a drug candidate entering a preclinical trial to eventually […]

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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 estimated that it costs somewhere between $161 million and $2 billion to bring a new drug to market.

The high costs, long timeframes and poor success rates inherent in traditional drug development and discovery processes have scientists seeking out new paths to innovation. With technological advances such as next-generation sequencing (NGS), the internet-of-things (IoT), increased computational power, and machine learning, leading pharmaceutical companies are now turning to advanced analytics and machine learning to spur the discovery of novel compounds and improve the efficiency of drug discovery and development.

According to Market Research Future, the global commercial pharma analytics market is expected to reach over $9 billion by 2027. In this blog, we will discuss some of the benefits of utilizing BIOVIA Pipeline Pilot and its advanced analytics and modeling capabilities to enhance drug discovery.

Advanced Analytics and Modeling In Pharma

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 extensive testing to evaluate criteria such as their dose-response curve, cellular efficacy, affinity towards the target, reactivity with other compounds, cytotoxicity, etc.

Real world data and experimentation are and always will be extremely important for answering scientific questions in the drug discovery process. That said, the traditional approach of just doing physical experiments to discover and validate drug candidates is very expensive and time-consuming – just one assay can cost hundreds of dollars, not to mention the synthesis costs. Additionally, physical testing typically yields very small data sets for the money and effort it takes to run the experiments.

Advances in computational power have opened up the possibility of creating digital models utilizing advanced analytics and machine learning that can dramatically accelerate innovation and yield inexpensive predictions from expensive data. These in silico methods use mathematical, probabilistic, and statistical modeling techniques to enable predictive processing and automated decision making. Modeling and simulation allows companies to save costs and time by working in the virtual world to innovate and learn, and then only moving into physical when the model is ready to be verified or tested.

Virtual modeling with advanced analytics allows scientists to create a wide variety of virtual compounds, test them with virtual assays, and prune to retain only the best performing compounds that are then moved into physical experiments. This allows scientists to only spend significant resources on the candidates that have the best chances of success. Also, the new data that these physical tests create can be feed back into the virtual models to refine accuracy and thus enhance predictive ability.

A few of the many ways in which scientists are applying these virtual modeling techniques to improve overall R&D efficiency include:

  • Identify and remove poor quality candidates sooner in the development pipeline
  • Create high quality candidates more quickly
  • Make sure that only high-quality candidates enter late stage R&D
  • Increase the likelihood of a given candidate’s success
  • Reduce time to market and development cost
  • Bring later stage processes like manufacturability upstream into early R&D

The Data Scientist Deficit

In order to design and implement effective models that produce actionable insights to advance drug discovery, you need data scientists with extensive knowledge in the life sciences and deep technical knowledge and expertise. Data scientists need to know what questions to ask and how to ask them, and they have to design, build, train, and validate each model to ensure high quality results. Unfortunately, there is currently a significant gap in the pharmaceutical industry between the supply and demand for good data scientists with the requisite skills, and the demand is projected to increase significantly in the coming years.

Organizations need skilled and experienced data scientists to develop global models that are designed to work for an organization’s entire compound portfolio – typically a collection of hundreds of thousands of molecules. Bench scientists, on the other hand, want more specialized local models that have been optimized for their compounds.

Due to the data scientist gap, experienced data scientists on staff are often swamped with requests for project-centric models by scientists, which only serves to take time away from their ability to develop and maintain global models that have wider applicability and strategic use for the enterprise. This leaves bench scientists in a bind – they can either wait in line for a more specialized local models to be developed by the data science team, or struggle for weeks through the process themselves, which typically ends up resulting in poorer quality models.

Democratizing Data Science with BIOVIA Pipeline Pilot

BIOVIA Pipeline Pilot is a graphical scientific authoring application that provides a comprehensive environment for the design, training, validation, and deployment of virtual models utilizing advanced analytics. It provides a drag-and-drop graphical user interface with “components” that allow common code to be shared throughout the organization. The platform supports a wide range of analytics capabilities, component collections, and domain-specific functionalities to support a full battery of scientific tasks for your organization.

BIOVIA Pipeline Pilot helps to address the data scientist gap by democratizing the role of data scientists. The graphical user interface allows bench scientists to develop specific data workflows utilizing prebuilt components and predictive algorithms to carry out tasks without needing any prior coding experience. The Analytics and Machine Learning Collection for Pipeline Pilot gives scientists the tools for everything from data ingestion, cleaning and exploration, to model building, validation, deployment, optimization, and design of future experiments – all within a single environment.

Expert users can create their own custom components using languages like Python or R to capture best practices and share them throughout the organization. These protocols can be deployed as a simple UI or as web services to allow scientists to easily tailor models to their specific needs or run individual instances of these models. The protocols can also be deployed as robots operating in the background to automate many data analytics processes.

Pipeline Pilot facilitates the conversion of broadly applicable global models into local models that are optimized for a specific set of compounds. It empowers researchers to create their own custom, domain-specific analyses with a library of curated scientific component collections, or use applications built by their colleagues to more rapidly get insights. Previously, this kind of model development and analysis would have required a team of data scientists to implement on a case-by-case basis, but the technologies that constitute Pipeline Pilot allow bench scientists to carry out this work at their desks.

It is important to note that this approach neither diminishes expert data scientists’ utility nor changes their role – it simply gives non-expert users the ability to tailor their models to better support individual decisions. All of this frees up the expert data scientists in your organization, allowing them to focus on creating and publishing new global models for widespread use.

Finally, Pipeline Pilot offers a wide variety of APIs to facilitate integration with a number of instruments and third-party software, allowing automatic extraction of data for analysis. Pipeline Pilot has the ability to ingest a large variety of data types (e.g., numerical, chemical, genomic, proteomic, textual, and image) from different locations, allowing your organization to integrate a wide range of data sources and types into a collaborative framework.

Key Capabilities of Pipeline Pilot include:

  • Apply any of 15+ machine learning (ML) methods to your scientific and engineering data
  • Merge, join, characterize, and clean your data sets
  • Perform exploratory analysis, including PCA, clustering, and multi-dimensional data visualization
  • Build fast, scalable Bayesian classification models
  • Use the GFA method’s genetic algorithm for variable selection and building regression ensemble models
  • Build accurate, easy-to-use RP Forest regression and classification models
  • Use R-based ML methods such as support vector machines, neural networks, and XGBoost without writing R scripts
  • Employ the ML framework for cross-validation, hyperparameter tuning, and variable importance assessment for any type of model
  • Use regression and classification model evaluation viewers to assess and compare model test set performance
  • Use built-in applicability domain measures and error models to assess sample-specific prediction confidence
  • Apply Pareto optimization to multi-objective optimization problems

Conclusion

Modeling with advanced analytics has enabled scientists in almost every industry to leverage data-driven decision-making to optimize products and processes. Until recently, however, a lack of domain specific data scientists has limited the application of modeling in the pharmaceutical industry. With the deployment of a global data science platform like BIOVIA Pipeline Pilot, modeling and advanced analytics become available to bench scientists in your organization to drive the innovation engine of drug discovery. Pipeline Pilot allows data science to become a fundamental part of your organization’s R&D and manufacturing culture, adding laser precision to predictions and giving scientists a deeper understanding of trends within their individual compound libraries.

Pipeline Pilot will help your organization to:

  • Tackle more complex problems and look at areas of research that you previously thought were inaccessible
  • Expand your data science team’s expertise across the organization
  • Ensure that data science best practices become the standard for your organization
  • Empower bench scientists to help develop actionable insights with the latest analytics and machine learning capabilities
  • Make the most of all of your data
  • Make decisions and drive R&D from a larger pool of data

BIOVIA Pipeline Pilot is the foundation for an effective data science platform that supports standardization of practices across the enterprise – data ingestion, data preparation, advanced modeling (both testing and deployment), data exploration and visualization. Pipeline Pilot can also be utilized as a core configuration/customization language to extend the power of many other BIOVIA applications (LIMS, chemical and biological registration, and other routinely used biopharma software systems).

To get the most out of your Pipeline Pilot investment, it is important to work with a quality informatics consultant who understands the platform, your applications, and your scientific domain, and will work with you to complete the necessary business analysis and requirements gathering. Astrix has an experienced team of Pipeline Pilot experts that can provide services for all your Pipeline Pilot needs including implementation, instrument and system integration, workflow and application authoring, custom reports, user training and more. As the premier BIOVIA Services partner, Astrix provides increased value to customers through cost effective design, implementation and/or integration services leveraging BIOVIA applications and software.

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Designing the Unified Lab of the Future with BIOVIA ONE Lab https://astrixinc.com/blog/biovia/designing-the-unified-lab-of-the-future-with-biovia-one-lab/ Wed, 12 Aug 2020 12:02:49 +0000 http://localhost/astrix/?p=3635 The need for optimizing operational efficiency while maintaining data integrity is at […]

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The need for optimizing operational efficiency while maintaining data integrity is at the core of every laboratory informatics roadmap.  Innovative technologies such as BIOVIA ONE Lab, that enable digital transformation holds the key to driving process improvement and automating daily tasks within the laboratory, but the challenge lies within how to go about this effort?  With so many choices for LIMS, ELN, LES, CDS, and Sample Management tools available in the marketplace today, how do you choose the process and platform that is best suited for your digital transformation journey?

Having the right systems in place for each of the primary functions within the laboratory is a critical starting point for digitalizing your workflow, however, unified connectivity between these technologies is what will allow you to transform your operations into the lab of the future.

Transforming your Laboratory Through Connectivity Enables:

  • Seamless integration of the entire process workflow
  • Facilitates an agile transfer of data and information
  • Real-time data and knowledge based decision making
  • Collaboration between teams across multiple sites
  • Eliminates departmental and data silos
  • Real-time data and knowledge based decision making
  • Unified role-based user experience for the lab

Achieving this level of connectivity requires a defined set of operating standards across a platform-based cloud enterprise.  Data collection and storage formats, taxonomies and ontologies, processes, and governance of data management just to name a few, are all examples of areas for standardization.  Deploying your system within a cloud enterprise opens the door to future of laboratory computing.  It allows for on-demand access to a shared network of configured computing resources via the internet, enables mobile accessibility in a time of remote work, offers security and flexibility, increases collaboration and allows for easy management of software and hardware life cycles.  As your laboratory grows, cloud computing facilitates the creation of new virtual computers as user demands increase.

As you embark down the path of your digital transformation journey, new technologies such as artificial intelligence (AI), machine learning and data science have the ability to further automate and transform processes within the laboratory.  AI learns from existing data, identifies patterns in the new data, and offers the ability to make decisions in real time.  Combining cloud technology with AI can perform more complex tasks with less centralized hardware.

BIOVIA ONE Lab provides a comprehensive platform for all of your informatics needs in a unified lab management solution.  The cloud-based connectivity features within ONE Lab enables you to eliminate manual or paper-based processes, develop turn-key methodologies, automate data review, manage sample inventory, and provide audit trail tracking throughout the entire process.

BIOVIA Pipeline Pilot further optimizes the research innovation process by employing a scalable framework to automate the scientific analysis of data across the enterprise, allowing users to accelerate access to data and easily visualize and report on their research results. It’s deep learning capabilities streamlines the processing and analyzing of image data, while integrating with the relevant numerical, chemical, graphical and textual data across a unified enterprise.

To get the most out of your BIOVIA ONE Lab implementation, it is important to work with a quality informatics consultant who understands the platform, your applications, and your scientific domain, and will work with you to complete the necessary business analysis and requirements gathering surrounding your successful digital transformation journey. Astrix has an experienced team of BIOVIA product experts that can provide services for all your support needs including implementation, instrument and system integration, workflow and method authoring, custom reporting, planning and system administration and user training.

BIOVIA ONE Lab Suite of Products Supported by Astrix:

  • Lab Management (Foundation HUB, Task Plan)
  • Procedure Execution (Compose, Capture & Review)
  • Electronic Lab Notebook (Notebook & Workbook)
  • Materials Management (CISPro, Registration)
  • Data Science (Pipeline Pilot)

BIOVIA’s leading ONE Lab solution, coupled with the services expertise of Astrix, will provide your laboratory with the foundation you need to accelerate a successful digital transformation program both on-premise and in the cloud.

As the premier BIOVIA Services partner, Astrix provides increased value to customers through cost effective design, implementation and/or integration services leveraging BIOVIA applications and software. If you wish to learn more about Astrix services, or if you wish to discuss your overall laboratory informatics strategy with an Astrix expert, please don’t hesitate to contact us.

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Creating Validation Documentation for BIOVIA Applications https://astrixinc.com/blog/creating-validation-documentation-for-biovia-applications/ Tue, 05 May 2020 13:53:35 +0000 http://astrixinc.com/?p=1931 Computer systems have produced significant changes to business processes in every industry […]

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Computer systems have produced significant changes to business processes in every industry by facilitating workflow automation and information management. These technologies are used to transform internal business processes, as well as enhance how businesses interface with customers and other businesses.

Computer system validation (CSV) is a documented process which assures that a computerized system does exactly what it is designed to do in a consistent and reproducible manner. Validation of computer systems is required by most regulatory agencies around the world in order to confirm data accuracy and integrity in systems so that product safety and effectiveness is ensured. The FDA, for example, requires pharmaceutical companies to perform CSV for systems that support the production of the following products:

  • Pharmaceuticals
  • Biologicals
  • Medical Devices
  • Blood and blood components
  • Human cell and tissue products
  • Infant Formulas

Computer system validation is required when either making a change in a validated system (upgrades, patches, extensions, etc.), or configuring a new system.

In today’s challenging economic environment, companies are seeking to improve operational efficiencies while keeping pace with the ever-evolving regulatory landscape. Toward this end, computer systems that streamline compliance and provide efficiencies over paper-based processes are deemed essential. Too often, however, companies get locked into the initial version of their software due to the cumbersome impact and cost CSV has on the upgrade process. In this article, we will give a basic overview of validation best practices, and discuss how BIOVIA applications are designed to avoid the version lock scenario and significantly reduce the amount of work required to complete necessary CSV processes.

Computer System Validation Basics

An effective CSV process helps to assure that both new and existing computer systems consistently fulfill their intended purpose by producing results which facilitate data accuracy and reliability, regulatory compliance, consistent intended performance, fulfillment of user requirements, and the ability to discern invalid and/or altered records. CSV requires the use of both static and dynamic testing activities that are conducted throughout the software development lifecycle (SDLC).

A “Computer System” in an FDA regulated laboratory is more than just computer hardware and software – it also includes any equipment and instruments connected to the system, as well as users that operate the system and/or equipment using Standard Operating Procedures (SOPs) and manuals. The FDA defines software validation as “Confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled.” In other words, the software must be examined to confirm that it functions as defined in the requirements and is suitable for its intended use. The examination also needs to confirm that the software will work in all situations. Finally, all validation activities and test results need to be documented.

It is critical that companies perform risk-based CSV. It never makes sense to try to validate every aspect of every system. CSV takes a lot of time and IT resources to accomplish, so it is wise to do a thorough risk assessment to determine what is practical and achievable. CSV efforts should concentrate on the critical elements of the system that affect quality assurance and regulatory compliance.

The first step in this process is to determine user requirements and functional specifications for the system in question. Once this is accomplished, a Validation Plan is developed that outlines the following:

  • Scope – defines parts of system to be validated and deliverables. Scope is limited to the features of the software that will be utilized by the regulated company.
  • Testing Approach – types of data you are going to use, types of scenarios you are going to test
  • Roles and responsibilities – the roles and responsibilities of the different people involved in the validation process
  • Acceptance criteria – defines conditions that need to be fulfilled before this system is considered suitable for use in the regulated activity

Once the Validation Plan is complete, CSV testing is performed:

  • Network and Infrastructure Qualification – demonstrates that the network and infrastructure hardware/software supporting the application system being validated has been installed correctly and is functioning as intended
  • Installation Qualification (IQ) – demonstrates that system has been installed correctly in user environment
  • Operational Qualification (OQ) – demonstrates that system does what it is intended to do in user environment
  • Performance Qualification (PQ) – demonstrates that system does what it is intended to do with trained people following SOPs in the production environment even under worst case conditions

The CSV process concludes with a Validation Report that documents the results of the testing:

  • Confirms that everything you set out to do in validation plan has been accomplished
  • Testing summary and list of open defects (along with justification for why the system can be used with these defects)
  • Confirms that user acceptance criteria have been met
  • Authorizes deployment of the system

In addition to performing CSV on internal systems, an FDA-regulated company needs to be prepared to audit third-party service providers (e.g., CROs), along with vendors of critical applications and cloud-based services (SaaS). The manufacturer of an FDA-regulated product is ultimately responsible for the integrity of the data that supports the product’s efficacy and safety, so if third-party vendors or service providers are used, the manufacturer needs to take appropriate steps to ensure that they are operating under standards that would hold up under an FDA inspection.

A risk-based assessment should be conducted to determine if an audit is necessary. At the minimum, formal agreements that clearly detail responsibilities must exist between the manufacturer and any third parties that are used to provide, install, configure, integrate, validate, maintain or modify a computerized system.

Validation for BIOVIA Applications

BIOVIA applications can be utilized to establish a digital thread over the full product lifecycle – from early materials discovery all the way through to product use and the customer experience. The integrated digital environment that is enabled with BIOVIA software provides numerous important benefits such as enhanced innovation, accelerated product development, improved process efficiency, and reduced cost and compliance risk.

In recognition of the challenges that CSV presents to companies in regulated industries, BIOVIA has designed automated validation tools that work with their software applications. A generic validation package is available containing testing scripts that help validate core functionality. Every time a piece of BIOVIA software gets updated or has new features added, the validation package is updated accordingly so it remains up to date.

The BIOVIA validation package comes with test scripts to follow, along with the set of requirements they are based on. This allows the customer to have a better understanding of what is being tested. The validation package contains:

  • Software requirements
  • Test scripts that are cross referenced with requirements
  • Evidence of test execution at Biovia before release

When the system is configured or customized in ways that deviate from core functionality, the cross referencing of test scrips with requirements allows the customer to easily identify which testing scripts need to be modified from what is provided in the validation package.

With BIOVIA applications, a lot of the OQ testing is already done for you. The ability to easily validate common workflows with this package removes much of the burden of CSV for users of BIOVIA applications, since customers will only need to develop validation scripts for unique configurations or customization work that is done.

The ease of validation for BIOVIA applications helps facilitate regular upgrades. The user community benefits from enhancements in subsequent releases of the software in addition to more up to date support and training. In addition, once the system configuration has been validated, BIOVIA software allows layered permissions to prevent lab technicians from changing the system configuration. This ensures that technicians perform all work on a validated system.

Why Astrix

When performing CSV, it is important to work with a quality consultant who understands FDA regulations (or the regulations for your specific industry) and can perform a risk-based assessment. This will help you identify critical validation processes that have a big impact on quality assurance and regulatory compliance, and ensure that you develop the proper scope for your validation efforts. A good CSV consultant can save you significant amounts of time and money in this area.

At Astrix, we are experts in IT risk identification and management including decades of regulatory compliance expertise. As such, we understand that computer system validation is not a “one size fits all” process. With over 20 years of validation experience, we work to create CSV processes that are based on applicable regulations and guidance, best practices for the domain, and the characteristics of the system being validated. Our validation professionals constantly update their knowledge of industry “best practices,” and stay abreast of regulations so we can help you comply with complex and ever-changing global compliance requirements.

Our CSV deliverables typically include:

  • System inventory and assessment – determination of which systems need to be validated
  • User requirement specifications – clearly defines what the system should do, along with operational (regulatory) constraints
  • Validation Plan – defines objectives of the validation and approach for maintaining validation status
  • Validation Risk assessments – analysis of failure scenarios to determine scope of validation efforts
  • Functional requirement specifications – clearly defines how the system will look and function for the user to be able to achieve the user requirements.
  • Validation Traceability Matrix – cross reference between user and functional requirements and verification that everything has been tested
  • Network and Infrastructure Qualification – documentation showing that the network and infrastructure hardware/software supporting the application system being validated has been installed correctly and is functioning as intended
  • Installation Qualification (IQ) Scripts and Results – test cases for checking that system has been installed correctly in user environment
  • Operational Qualification (OQ) Scripts and Results – test cases for checking that system does what it is intended to do in user environment
  • Performance Qualification (PQ) Scripts and Results – test cases for checking that System does what it is intended to do with trained people following SOPs in the production environment even under worst case conditions
  • Validation Report – a review of all activities and documents against the Validation Plan
  • System Release Documentation – documents that validation activities are complete and the system is available for intended use.

With a thorough understanding of the SDLC, complemented by our experience with and knowledge of business processes in numerous sectors, Astrix can offer CSV support for all BIOVIA applications in any industry. Our computer system validation professionals provide you with a best practice CSV methodology, along with the peace of mind that comes from knowing your CSV documentation has been produced by experts. Additionally, we staff projects based on required expertise and scope, and provide nearshoring options in order to offer the most efficient and cost-effective CSV services possible.

Finally, our experienced professionals can provide support for all aspects of your BIOVIA informatics projects, from system architecture and design to implementation and integration. As the premier BIOVIA services partner, Astrix offers increased value to customers through specific design, implementation and/or integration services leveraging BIOVIA applications and software. Utilizing BIOVIA applications, Astrix helps enterprises build a scalable, integrated, and supported laboratory informatics application landscape.

Conclusion

Effective, risk-based validation of computerized systems is becoming more and more critical in light of new rules effected by international regulatory agencies. In addition to version lock, poor product quality and excessive consumption of IT resources, the cost of inefficient or ineffective CSV processes can include regulatory action. With regards to the FDA, for example, the consequences of failing to do adequate CSV may include one or more of the following:

  • Warning Letters
  • Product seizures
  • Import restrictions
  • Clinical hold
  • Rejection of application data
  • Delay in approval of new products or facilities
  • Consent decree
  • Injunction
  • Disqualification of clinical investigators
  • Debarment
  • Criminal prosecution

These actions can be costly and even potentially devastating to an organization. In order to avoid them, it is wise to work with a quality informatics consultant who understands the regulations in your industry and can perform efficient and effective risk-based CSV assessment and testing.

About Astrix

Astrix is the unrivaled market-leader in creating & delivering innovative strategies, solutions, and people to the life science community.  Through world class people, process, and technology, Astrix works with clients to fundamentally improve business & scientific outcomes and the quality of life everywhere. Founded by scientists to solve the unique challenges of the life science community, Astrix offers a growing array of strategic, technical, and staffing services designed to deliver value to clients across their organizations.

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Chemical Inventory Management Best Practices for BIOVIA CISPro https://astrixinc.com/blog/lab-informatics/chemical-inventory-management-for-biovia-cispro/ Wed, 06 Feb 2019 20:31:55 +0000 http://localhost/astrix/?p=2730 Companies that use chemicals in a lab or their manufacturing process need […]

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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.  Biovia CISPro is a solution that can hhelp.

Many organizations still track chemical inventory with basic paper notebooks or spreadsheets, or with difficult-to-use legacy systems that were developed in-house. Such systems do not effectively support accurate and up-to-date chemical inventory data, which can result in unnecessary duplicate ordering, excess purchasing (“safety” stock) to ensure necessary materials are on hand, high disposal costs, and disruption to your business when the necessary chemicals are not available.

Poor management of chemical inventory can in fact have a significant impact on operating costs. The reality is that every organization incurs costs for equipment, materials, labor, liability, safety training and compliance efforts at every stage in the chemical inventory management lifecycle. Beyond basic tracking of chemical inventory, there are literally hundreds of complicated inventory management processes that serve to optimize logistics and deployment, replenishment, disposition and forecasting.

Industry leading organizations are significantly reducing risk and costs by implementing chemical inventory management systems that allow for operational optimization. In this blog, we will discuss best practice recommendations for chemical inventory management and describe some of the features of the BIOVIA CISPro Chemical Inventory System that allow these recommendations to be put into practice.

Best Practices for Chemical Inventory Management

Best practices in chemical inventory management takes full advantage of the people, processes, and technology involved to drive operational excellence and risk mitigation. Some best practice recommendations for chemical inventory management include:

  • Identify your inventory system components and optimize them
  • Use your system to manage and mitigate the quantity of chemicals on-site
  • Optimize chemical safety and inventory data
  • Align with regulatory requirements from EPA and OSHA, as well as any state and local requirements
  • Develop the ability to access current safety data sheet (SDS) information in real-time
  • Identify and eliminate any chemical safety issues
  • Enhance process efficiencies by streamlining lot tracking and qualification
  • Automate regulatory reporting
  • Automate audit trails
  • Quantify inventory management costs
  • Reduce inventory management cost

In order to align with these best practice recommendations, it is imperative for organizations to implement an integrated, centralized chemical inventory management system. A good chemical inventory management solution acts proactively to supplement lab processes instead of waiting for input. It will facilitate effective implementation of the best practices listed above and address other problem areas, allowing the organization to maintain accurate chemical inventory information in real-time and make the best use of all chemicals in all facilities.

Part of best practices for chemical inventory management is also facilitating adoption of the system. The reality is that getting scientists and other personnel interested in using a chemical inventory system is not necessarily easy. And even when this goal is accomplished, you must work to eliminate noncompliant usage.

A best practices solution should be easy to learn and use and training requirements should be minimal in order to ensure adoption. Towards this end, the project team implementing the system should configure and integrate the software with the user in mind: the process to pull items from inventory should not be complicated, key items should not be hidden, reports should be automated, triggers should be created to send an alert to the responsible person when inventory is low, the system should provide seamless integration with other systems in the organization, etc.

Corporate culture will need to evolve to accommodate the new system. Don’t expect the new system to conform to your existing workflows. With the implementation of a new system, new capabilities will be available, and workflows will change. Expect this and plan for effective change management.

BIOVIA CISPro Chemical Inventory System

The BIOVIA CISPro Chemical Inventory System is a comprehensive, web-based, best-in-class solution for multi-site tracking and managing laboratory supplies and chemicals over the full material lifecycle. By barcoding chemicals upon receipt, CISPro allows tracking of all the chemicals in your facility in real-time – you can track chemical receipt, sample verification and approval, lot release, threshold levels for compliance, re-labeling, requisitioning, dispensing, expiry, storage and container deletion.

CISPro also has features that support role-based user permissions and security, complete archiving and versioning, complete audit trails, remote inventory control, automated email notifications, report generation, quick access to hazard information in case of an emergency, and much more. Whether accessing the system from a mobile device or a computer, CISPro provides an intuitive and easy-to-use user interface with powerful features for editing, search & retrieval and reporting.

CISPro also offers a variety of integrations and modules:

  • Integration with any laboratory informatics application of the BIOVIA Unified Lab Management offering like ELN, Compose and Capture etc.
  • Integration with 3rd-party laboratory informatics solutions like ELN, LIMS or LES
  • ACD for CISPro Module enables integrated searches of commercially available chemicals based on different search criteria including chemical structures
  • Fire Code Reporting Module for hazardous materials reporting
  • Regulatory Lists Module integrates with 3E’s Ariel regulatory compliance tools
  • SDS Provider Module integrates with SiteHawk’s SDS Management Services
  • Integration with Scitegrity for identification of controlled substances based on structure

By going beyond the minimal requirements for a chemical inventory system, CISPro allows company personnel to focus on managing the products and processes that drive your business instead of just managing the chemical inventory.

Benefits of an Integrated Best Practice Chemical Inventory Management System

As a lifecycle-oriented Chemical Inventory Management system, CISPro provides numerous benefits beyond those incurred by basic inventory management. Some of these include:

  • Helps minimize the number and amount of chemicals stored
  • Helps minimize waste generation and controls waste disposal costs
  • Streamlines critical lab activities such as batch processing
  • Facilitates budget preparation and planning by maintaining information on usage patterns, age, shelf-life and cost
  • Provides quicker access to in-house materials through a shared inventory solution
  • Allows regulatory compliance to be built into company workflows and business processes through integration of the system into overall IT infrastructure
  • Simplifies the audit process by allowing automated report generation
  • Enhances accessibility of safety data by making it available in a web browser with only a few clicks
  • Facilitates user adoption with an intuitive and easy-to-use user interface that is consistent from site to site
  • Enables integration with future technology innovation with open architecture
  • Enables risk mitigation strategies for managing hazardous materials on-site
  • Keeps management apprised of chemical inventory costs with timely reporting
  • Reduces labor costs by increasing overall laboratory operational efficiency

Conclusion

While simply knowing which chemicals are in stock and where they are located can reduce regulatory scrutiny and address management concerns, a state-of-the-art chemical inventory management system like CISPro can significantly reduce costs and enhance operational efficiency and effectiveness.

One of the keys to getting the most from a good Chemical Inventory Management System is to implement the system with user adoption in mind. The project team should conduct a thorough Business Process Analysis in order to create a set of optimized system requirements that will guide the implementation. Depending on the number of sites involved and the integration requirements, an architectural assessment along with a roadmap to deployment may also be necessary in order to ensure a successful implementation that drives maximum business value for your organization.

Astrix has over 20 years of experience facilitating success in laboratory informatics implementations. As a BIOVIA partner, Astrix offers increased value to customers through specific design, implementation and/or integration services leveraging BIOVIA applications and software. We help enterprises build a scalable, integrated, and supported laboratory informatics application landscape.  BIOVIA’s leading infrastructure, coupled with the services expertise of Astrix, provides our customers with the foundation, they need to accelerate success both on-premise or in the cloud.

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