Medical Manufacturing

OmegaCube ERP helps medical equipment manufacturers effectively manage key business processes and manufacture high-precision products that comply with stringent TS13485 & ISO 9001 standards and meet FDA requirements.

Key Benefits to Medical Equipment Manufacturers

Top Functional Areas in OmegaCube ERP for Medical Equipment Manufacturers

  • Track real-time inflow & outflow of inventory and gain greater visibility of the entire supply chain.
  • Trace the origin of a specific part/unit/entire product batch located within the supply chain.
  • Maintain lot items using Bar Code Scanner and Auto Inventory Transfer (Bar Code).
  • Track heat numbers, material composition data and attach mill certificates to lot numbers.
  • Track non-conformance through a centralized database integrated with RMA, Shop Floor transactions & inventory.
  • Analyze quality metrics for suppliers, parts, manufacturing, and operations using quality management dashboards.
  • Assign tasks, generate automatic emails/reminders, and document corrective & preventive action using 8D methodology.
  • Maintain a user-defined list of specifications a part should meet, their target values, and tolerances.
  • Document employee details such as educational qualifications, certifications, and work experience for specific tasks.
  • Maintain in-house training records of employees and track certification progress for each of them.
  • Track training expiration, and automatically generate alerts for new training requirements based on revision control on specific processes.
  • Track eligibility requirements for individual processes and link qualified employees.
  • Automatically generate production schedules based on employee eligibility.
  • Enter quotes for customers or prospects with expiration control and multiple revisions.
  • Build detailed estimates that include operation costs, material costs, outside services, etc.
  • Part and routing calculators with multi-level bills of material.
  • Trigger supplier RFQ and use the RFQ results in estimates.
  • Automatically create opportunities in CRM and track follow-up, and callbacks in CRM.
  • Manage your distributor or end-user data and communications in CRM.
  • Provide self-service reordering of repeat items using portals.
  • Manage and maintain multiple warehouses and track inventory movements between them.
  • Setup pricing rules for dealers, end users, and option pricing. Setup discount rules based on customer types, item types, etc
  • Utilize browser-based interface to publish configurator details to dealers and end-users.
  • Set up rules and formulas for generating manufacturing BOMs based on configuration. Create multi-level BOMs and routings automatically. 
  • Define set up security and access rules based on customer types.
  • Setup your own sequence of questions, screen layouts, and color schemes. Attach drawings, specifications, etc to the configured product.
  • Analyze transaction level detail for all financial numbers.
  • Drill down to source transactions.
  • Track date, time-stamp, and the user who performed the transaction.
  • Track changes to actual field data over a period of time.
  • Maintain activity logs for each task conducted at every phase of design, manufacturing, and dispatch.
  • Filter employee-wise, activity-wise, and project-wise logs for reporting & analytical purposes.
  • Increase chances of cause identification of discrepancies in processes, defects, etc.
  • Integrated business processes such as Manufacturing, CRM, Quality Management, CAPA, Finance & Accounting, etc. for smooth operations.
  • Advanced product traceability right from procurement to dispatch, genealogy, tracking through serial numbers, etc.
  • Audit trail and documentation for FDA audits.
  • On-premises and cloud-based deployment, access from anywhere, any browser, any supported device.
Traceability & Product Serialization
  • Track real-time inflow & outflow of inventory and gain greater visibility of the entire supply chain.
  • Trace the origin of a specific part/unit/entire product batch located within the supply chain.
  • Maintain lot items using Bar Code Scanner and Auto Inventory Transfer (Bar Code).
  • Track heat numbers, material composition data and attach mill certificates to lot numbers.
Quality Management
  • Track non-conformance through a centralized database integrated with RMA, Shop Floor transactions & inventory.
  • Analyze quality metrics for suppliers, parts, manufacturing, and operations using quality management dashboards.
  • Assign tasks, generate automatic emails/reminders, and document corrective & preventive action using 8D methodology.
  • Maintain a user-defined list of specifications a part should meet, their target values, and tolerances.
Employee Training & Certifications
  • Document employee details such as educational qualifications, certifications, and work experience for specific tasks.
  • Maintain in-house training records of employees and track certification progress for each of them.
  • Track training expiration, and automatically generate alerts for new training requirements based on revision control on specific processes.
  • Track eligibility requirements for individual processes and link qualified employees.
  • Automatically generate production schedules based on employee eligibility.
Estimating and Quoting
  • Enter quotes for customers or prospects with expiration control and multiple revisions.
  • Build detailed estimates that include operation costs, material costs, outside services, etc.
  • Part and routing calculators with multi-level bills of material.
  • Trigger supplier RFQ and use the RFQ results in estimates.
  • Automatically create opportunities in CRM and track follow-up, and callbacks in CRM.
Distribution Management
  • Manage your distributor or end-user data and communications in CRM.
  • Provide self-service reordering of repeat items using portals.
  • Manage and maintain multiple warehouses and track inventory movements between them.
Product Configurator
  • Setup pricing rules for dealers, end users, and option pricing. Setup discount rules based on customer types, item types, etc
  • Utilize browser-based interface to publish configurator details to dealers and end-users.
  • Set up rules and formulas for generating manufacturing BOMs based on configuration. Create multi-level BOMs and routings automatically. 
  • Define set up security and access rules based on customer types.
  • Setup your own sequence of questions, screen layouts, and color schemes. Attach drawings, specifications, etc to the configured product.
Audit Trail
  • Analyze transaction level detail for all financial numbers.
  • Drill down to source transactions.
  • Track date, time-stamp, and the user who performed the transaction.
  • Track changes to actual field data over a period of time.
Change Log for Transactions
  • Maintain activity logs for each task conducted at every phase of design, manufacturing, and dispatch.
  • Filter employee-wise, activity-wise, and project-wise logs for reporting & analytical purposes.
  • Increase chances of cause identification of discrepancies in processes, defects, etc.
21 CFR 11 Requirements
  • Integrated business processes such as Manufacturing, CRM, Quality Management, CAPA, Finance & Accounting, etc. for smooth operations.
  • Advanced product traceability right from procurement to dispatch, genealogy, tracking through serial numbers, etc.
  • Audit trail and documentation for FDA audits.
  • On-premises and cloud-based deployment, access from anywhere, any browser, any supported device.

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