OmegaCube ERP helps medical equipment manufacturers to effectively manage key business processes and manufacture high-precision products that comply to stringent TS13485 & ISO 9001 standards and meet FDA requirements.
- Adhere to TS13485 & ISO 9001 standards right from product planning till delivery via automation of key quality parameters.
- Meet compliance requirements by maintaining accurate genealogy and traceability throughout your supply chain.
- Track & maintain employee certifications for precision medical products, processes, and adherence to strict quality standards.
- Build detailed quotation and cost estimates to reduce time-to-quote and time-to-estimate leading to faster conversions.
- Maintain complete audit trial of manufacturing processes along with time stamps and personnel details.
- Maintain robust document and revision control to meet 21 CFR 11 requirements.
Key Features
Traceability and 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, operations using quality management dashboards.
- Assign tasks, generate automatic emails/reminders, document corrective & preventive action using 8D methodology.
- Maintain user-defined list of specifications a part should meet, their target values and tolerances.
Employee Training & Certifications
- Document employee details such as educational qualification, 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, 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 schedule based on employee eligibility.
Estimating and Quoting
- Enter quotes for customers or prospects with expiration control and multiple revisions.
- Build detailed estimates that includes operation costs, material costs, outside services etc.
- Part and routing calculators with multi-level bill of material.
- Trigger supplier RFQ and use the RFQ results in estimates.
- Automatically create opportunities in CRM and track follow-up, call backs etc. 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, 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.
- Setup rules and formulas for generating manufacturing BOMs based on configuration. Create multi-level BOMs and routings automatically.
- Define setup security and accessibility rules based on customer types.
- Setup your own sequence of questions, screen layouts, 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 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, 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 till dispatch, genealogy, tracking through serial numbers etc.
- Audit trial and documentation for FDA audits.
- On-premises and cloud based deployment, access from anywhere, any browser, any supported device.
OmegaCube ERP Platform
The OmegaCube ERP platform is a single source system that helps you automate your work flow, become more responsive and continually improve performance. It adapts to your changing business needs.
Sales Management
Improve Customer response, Sales by providing the right tools to your people.
Suppliers & Purchasing
Manage and streamline your purchasing process and control your costs, timing and quality.
Quality Management
Improve your customer retention by managing your quality process effectively.
Project Accounting
Execute your service or manufacturing projects professionally and effectively.
Planning & Scheduling
Synchronize MRP and scheduling with manufacturing process to deliver product on-time.
Product Configurator
Easy-to-use Configure-price-quote (CPQ) workflow to help improve sales and quoting efficiency.
EDI
Transact with business partners seamlessly.
Portals
Collaborate with vendors, customers and business partners.