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.

Adhere to TS13485 & ISO 9001 standards right from product planning to delivery via automation of key quality parameters.

Build detailed quotation and cost estimates to reduce time-to-quote and time-to-estimate leading to faster conversions.

Meet compliance requirements by maintaining accurate genealogy and traceability throughout your supply chain.

Maintain complete audit trial of manufacturing processes along with time stamps and personnel details.

Track & maintain employee certifications for precision medical products, processes, and adherence to strict quality standards.

Maintain robust document and revision control to meet 21 CFR 11 requirements.

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.