IntegrinCMO

IntegrinCMO is a software platform designed for Contract Manufacturers, Contract Research & Development 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.

Project Management

IntegrinCMO supports integrated Product Management with features including Task Management, Resource Management & Time management; External Service Providers can be assigned as resources for the project, and can be given Role based access to have a view access into the project; Multiple Projects can be handled together simultaneously and each project can have multiple tasks that can be assigned to different team members. Project team members can track time by entering project hours in time sheets. Project managers and senior management will have visibility on project cost, project timeline and resource utilization

Inventory Management

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

Audit Tracking

IntegrinCMO supports tracking customer/service provider activity using event based Audit tracking. 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.

Access Control

IntegrinCMO supports Role based access control, making sure only authorized users can perform the assigned functions depending on the User Role. IntegrinCMO 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.IntegrinCMO supports Service Provider / Customer portal with controlled access into their relationship with CMO.

Product Development & Manufacturing

IntegrinCMO 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. IntegrinCMO 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.

Financial

Realtime financial tracking is critical for success of a business, IntegrinCMO 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, IntegrinCMO also supports exporting financial data to Accounting System of choice.

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