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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

Arxspan 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, Arxspan 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 Arxspan 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. Arxspan Notebook features the SAFE BioPharma signature service for identity authentication associated with digital signatures in the pharmaceutical industry. Arxspan is GLP certified and 21 CFR Part 11 qualified.

The optional Arxspan Inventory module integrates with Arxspan 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 Arxspan 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.

Arxspan Products

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NOTEBOOK - ELN

The Arxspan 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...

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INVENTORY

Arxspan Inventory is a cloud-based inventory application providing a tool set to natively define and manage inventory items such as proprietary compounds...

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ASSAY

Arxspan 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...

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REGISTRATION

The Arxspan 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...

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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 Arxspan 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 Arxspan Notebook, increasing productivity while decreasing support requests.
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Innovative Compound Registration Workflow Using a Web-Based, Cloud-Hosted Electronic Lab Notebook

Download our white paper to learn how Sunovion Pharmaceuticals implemented an innovative registration process by using the Arxspan Notebook system, allowing CROs to register compounds directly into their registration system.
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