IntegrinRx

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 / Material selection process goes through approval workflows to make sure Product / Material information are captured accurately. Product / Material Quality control documents including Manufacturer CofA, Compliance Certificates such as TSE / BSE, Residual Solvent can be managed electronically in the system.

  IntegrinRx supports different life cycle status for Product / Material including Quarantined, Sampled, Conditionally Released, Fully Released, Expired etc. IntegrinRx also supports expiration dating of Product / Material at Inventory Lot level. Inventory Lot Label can be generated from the system for labeling the material inventory.

  IntegrinRx supports bi-directional traceability between Material and Product 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 supports Role based access control, making sure only authorized users can perform the assigned functions   depending on the User Role.

  IntegrinRx supports multi-level formulation and can track intermediate or WIP items.

  Calibration & Maintenance of fixed assets used in formulation or manufacturing process can be managed with in the  System.