As a Technology, Business Process and Compliance partner for many of the leading Medical Device companies, Intelligroup’s solutions and services include: |
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- Setup and Support ERP systems to help manage
- Real time capture of batch data, comparison against the Device Master Record and capture deviations and dispositions to create a complete DHRs, integrated with MES where required
- Lot and Serial Number Track and Trace, Product Recalls
- Distribution and Sales through Third Party Logistics providers, by providing a platform for daily data exchange (both to and from 3PLs) for Sales Orders Entered, Shipments to be made (along with specific lot assignments), shipments completed, invoices raised etc.
- Near real time updates on supplies through contract manufacturing operations via a portal for entry at source, or upload of data, with a view to maintain visibility into inventory movements, changes and impacts on upstream and downstream schedules;
- Product Configurations that can be planned and manufactured at an aggregate level and yet be assembled and configured just before shipment, to help implement the classic Postponement model in Supply Chain Management
- Manufacturing of high value, large and complex devices in a Project Manufacturing mode
- Risk Based GAMP5 Guidelines driven, right sized and faster Computer Systems Validation using our highly adaptable and reusable Validation artifacts and templates
- Best Practice and Best in Class Software Tools driven Test Planning, Development, Management and Execution; Test Maturity Assessment and Roadmap for advancement
- Comprehensive assessments of GMP / QSR / 21CFRP11 Compliance status of ERP and other systems and a well defined roadmap recommendations for achieving optimal compliance
- Manage Engineering and Changes and Quality Approvals with Electronic Signatures
- Implementation of Business Process Changes to ensure optimum use of available Inventory and for Compliance
- Deploying collaborative and end to end supply chain planning and execution tools for an accurate forecast of the demand, a full supply plan (including CMOs and Procurement), recoding of execution details, tracking the actual vs. plan, GMP Compliance and overall management of your supplies throughout the extended supply chain.
- Building, publishing and maintaining Device education portals targeted towards physicians, surgeons and hospitals.
- Consulting on overall IT Governance and development of IT related SOPs.
- And others
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