IntegrinRx

Pharmaceutical Manufacturers are challenged by a number of regulatory compliance requirements, when not met properly, adds non-compliance and risk to their business operations. Maintaining tight quality control and detailed product documentation including TSE/BSE, CoFA are required for regulatory compliance and to run business operations successfully. IntegrinRx is a software platform designed for drug manufacturers, Drug Delivery and Formulation Research organizations to run their operations in compliance with FDA regulations including cGMP (CFR 21 part 210, CFR 21 part 211), CFR 21 Part 11 and CFR 21 Part 820.

Product Administration

Product / Material selection process goes through approval workflows to make sure Product / Material information are captured accurately. Automated notifications are delivered to the users by Dashboard and Email notifications. Product / Material Quality control documents including Manufacturer CofA, Compliance Certificates such as TSE / BSE, Residual Solvent can be managed electronically in the system.Products / Materials can be categorized in Groups and Super Groups. Managers will have control over the products / materials that are on-boarded in the system, since only privileged users will be able to approve Product / Material requests to Products / Materials. IntegrinRx supports managing Product Feature Groups / Features and ability to attach product features to Products / Materials. Product Features can be maintained at Product / Material requests and are carried over to Products / Materials upon approval.

Order Management

IntegrinRx supports order management for customers, suppliers and service providers, with the ability to send orders electronically. Purchase requests can be generated automatically based on inventory threshold that is configured in the system and current inventory levels, and the requests can be converted to Purchase Orders based on approval workflow.

Inventory Management

Products / Materials can be received as a single product or against a purchase order. IntegrinRx supports different life cycle status for Product / Material including Quarantined, Sampled, Conditionally Released, Fully Released, Expired etc. IntegrinRx also supports expiration date for Product / Material at Inventory Lot level. Inventory Lot Label can be generated from the system for labeling the material inventory. IntegrinRx supports attaching various documents at the Inventory Lot level including Batch Record, Form 222, Certificate of Analysis (CoFA). IntegrinRx supports managing Inventory Feature Groups / Features and ability to attach Inventory features to Inventory Lots. IntegrinRx supports transferring products and materials across different warehouses with approval workflows, so that transfers are performed in a controlled manner and are accountable. IntegrinRx supports reconciliation of physical inventory against inventory in the system, to get insights on stock discrepancies and minimize those discrepancies. IntegrinRx also supports tracking inventory lot locations using a 5 level identification system, so that locating inventory can be seamless.

Traceability

IntegrinRx supports bi-directional traceability between Materials and Products thereby helping in traceability and Recall Management as needed. IntegrinRx supports reconciliation at the lot level for Control Substance inventory to meet DEA compliance.IntegrinRx captures audit logs as the event occurs, and also supports Perform By / Verify By for critical events, along with date/time of the event, thereby complying with CFR 21 Part 11. IntegrinRx Product Development or Manufacturing maintains lot level bi-directional traceability between Products, Intermediate / WIP Products and Raw Materials, with the ability to pick a specific inventory lot during Product Development or Manufacturing.

Access Control

IntegrinRx supports Role based access control, making sure only authorized users can perform the assigned functions depending on the User Role. IntegrinRx also supports multi-role user where a single user can perform mulitple roles, System Admin will be granted access to assign roles to other users.

Product Development & Manufacturing

IntegrinRx supports multi-level formulation and can track intermediate or WIP items. Product Development / Manufacturing process and components can be predefined and scheduled to run on a preset frequency. IntegrinRx supports Material planner to recommend batch runs based on current inventory levels and inventory minimums. Process Steps can be reused across different processes thereby avoiding duplicate process steps. Intermediate (WIP) Products can be checked into Inventory as separate Inventory Lots with a distinct batch number to maintain bi-directional traceability.

Calibration & Maintenance

Calibration & Maintenance of fixed assets used in formulation or manufacturing process can be managed and maintenance related tasks for different Fixed assets can be tracked in the system. IntegrinRx sends automated email notifications on maintenance schedules and calibration due dates.

Financial

Realtime financial tracking is critical for success of a business, IntegrinRx supports event based capturing of financial transactions as they occur in the system and thereby providing realtime financial insights to the CXOs and senior management. Invoices can be electronically processed and applied against the orders. Financial reports can be generated realtime, IntegrinRx also supports exporting financial data to Accounting System of choice.

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