Manufacturing

Streamlined workflow management enabling more efficient processes

Manufacturing functions across all industries continually face pressure to streamline operations, reduce costs, and adequately meet all technical, legal, and regulatory requirements.

In order to accomplish these goals, manufacturers must ensure tight control over all sequences of tasks in the laboratory. Data storage and retrieval must be simplified, and information must be easily shareable across multiple functions and locations within an organization. Experiments and processes must have adequate audit trails and traceability to ensure intellectual property protection and adherence to regulatory requirements associated with manufacturing and related processes. Furthermore, monitoring of personnel workflows and review capability of experiments is important.

Requiring data entry into electronic laboratory notebooks from the very beginning of all processes ensures that all of these requirements can be met. ELNs document work product in a central format, create secure and real-time data access, allow for collaboration, ensure full audit trail of all processes, and allow for management to conveniently review work product.

Benefits for Manufacturing

ArxLab® Notebook handles the strictest manufacturing requirements by offering an ELN that securely manages all research and process data while at the same time being flexible enough to adapt to new or changed processes. The system provides different types of experiments to manage chemical, biological, or engineering-related manufacturing as well as analytical characterization of manufactured compounds or components. Templates for repetitive procedures can be setup, facilitating process automation and elimination of manual errors. For chemical and biological manufacturing, ArxLab offers useful functionalities such as reaction tracking, automated compound checking for regulatory compliance, and an affiliated database for tracking manufacturing-related degradants and impurities.

The cloud-based aspect of ArxLab Notebook ensures effective, duplication-free collaboration across all internal technical groups as well as external groups such as CROs. Experimental notebooks can be shared with complete or restricted access to any group or individual, protocols can be copied from one operator to another, and process/quality test requests can be established. All experimental protocols can be signed by operators and approved or rejected by managers overseeing operations. ArxLab Notebook features the SAFE BioPharma signature service for identity authentication associated with digital signatures in the pharmaceutical industry. ArxLab is GLP certified and 21 CFR Part 11 qualified.

The optional ArxLab Inventory module integrates with ArxLab Notebook and allows users to decrement inventory for use in procedures or experiments. Users can keep separate inventory stock for research, process development, manufacturing, and quality operations. Attachments such as MSDS and hazard, safety, and flammability reports can be stored in the system.

The optional ArxLab Assay module enables registration of assays and procedures for manufacturing as well as for process and formulation development. Users can register manufacturing trial settings and results, develop and document intellectual property associated with processes, and search and sort data for decision making.

ArxLab® Products

Electronic Laboratory Notebook (ELN)

The ArxLab ® Notebook product is a cloud-based Electronic Laboratory Notebook (ELN) and Workflow solution built to serve as an authoritative repository for Chemistry and Biology data, optimized for the collaborative research models ubiquitous in today’s commercial and academic research environments. It is highly effective at allowing organizations to collaborate and securely share research information with outside industrial partners, academic collaborators, and CROs. The system can deploy in one business day, includes experiment signing/witnessing capability and audit trails, is 21 CFR Part 11 compliant, and offers robust functionality to support chemistry and biology workflows.

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Registration for Chemistry and Biology

The ArxLab® ChemReg and BioReg modules are a cloud-based solution built to serve as an authoritative repository for unique chemical and biological entities. The system handles cases of uniqueness (identity) criteria, mixtures, and cross-referencing, all within a single system that offers unified search across all entities, including chemically intelligent searching when a structure is present. PerkinElmer ChemDraw® is integrated for chemical drawing, and ChemAxon chemical intelligence functionality enables chemical search, property calculations, and full support for salts, mixtures, formulations, tautomers, and all types of isomers.

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Assay

ArxLab® Assay is a cloud-based software tool set that can define, collect, manage, and store assay endpoint data – ideal for assay development functions as well as LTS and HTS screening programs. It provides study coordinators an integrated view of study activity and centrally manages data across multiple research groups and facilities. Users can specify required and optional parameters, data types, allowed ranges, and more. ArxLab Assay can perform automated calculation of raw data values, generate curves and heat maps, and allow for point knockouts for curves.

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Inventory

ArxLab® Inventory is a cloud-based inventory application providing a tool set to natively define and manage inventory items such as proprietary compounds, commercial reagents, samples, consumables, equipment, and other inventory items. Common operations include tracking of receiving, container history, usage levels by user, container location, material check-in/check-out, plate management, and audit trail. User-defined location hierarchy provides for exact locations of stored materials within a building, laboratory, bench-top, freezer, etc. Users can configure container type and storage locations and search by any field, or by chemical structure.

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Decision Support

ArxLab® Search is a decision support tool enabling querying, visualizing, and reporting of data from the ArxLab® Notebook, Registration, Assay, and Inventory modules. It allows users to perform real-time searching and sorting of compound, material, assay, and inventory data, and to customize the layout of these results. Users can save save search and filter parameters, perform basic mathematical calculations, visualize chemical structures, create customizable graphs, generate 2D plotting, perform structure-activity relationship analyses, export tables to Microsoft Excel, and more. ArxLab Search can also integrate with external data repositories, offering data visualization functionality for any client information.

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Workflow

Project and work request management: ArxLab Workflow is a comprehensive project and work request management system, allowing managers to make work requests and track the progress of these requests, as well as of other projects and activities. It allows users to create new work requests and to assign them to users and/or groups. Workflow allows for designation of which users or groups are allowed to: create new requests, view requests, edit requests, delete requests, and be assigned requests. Managers can submit multiple items or requirements for one request/workflow via manual entry or bulk file import.

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Related White Papers and Information

 

Cloud-Based Electronic Notebooks - The New Generation

Download our white paper to learn how Sunovion Pharmaceuticals adopted ArxLab Notebook to transition from paper notebooks internally, as well as to effectively manage incoming CRO data.

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Cloud-Based Electronic Notebooks - Migrating From Old to New

Download our white paper to learn how Constellation Pharmaceuticals replaced its existing client-server installation of its electronic laboratory notebook with ArxLab Notebook, increasing productivity while decreasing support requests.

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