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Manufacturing

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.

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.


 
Arxspan's ArxLab product line is a platform for the pharmaceutical, biotechnology, chemical, material science, consumer goods, and food & beverage industries.
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