Product Lifecycle Management (PLM) systems manage data relating to produce design, production, support and retirement or disposal of manufactured goods. PLM systems provide a system of record to integrate people, data, processes and business processes. In the life science industry, it is critical to maintain and control the historical documentation and information that defines each product (medical devices, drugs, etc) at each phase of its development.
USDM has built a practice around implementation of PLM systems. From implementation to retirement, USDM provides a complete documentation and services package to ensure regulatory compliance.
Our services include:
- PLM Implementation & Configuration
- Integration Plans for Integrating PLM with other facility systems
- PLM Validation Packages
- PLM Training - Sys Admin/ End-User
- Standard Operating Procedures
- Legacy System Decommissioning
- Data Migration Plans
Key Differentiator – The USDM Validation Accelerator Packs:
USDM has built Validation Accelerator Packs (VAPs) for a variety of PLM platforms. These VAPs are a complete set of validation document templates for the system based on common, general requirements for life science companies and contain the following compliance documentation
- Computer System Validation Plan
- Risk Assessment
- System Requirements Specification
- Installation Qualification
- Operational Qualification
- Performance Qualification
- Traceability Matrix
- Standard Operating Procedure Checklist
- Validation Summary Report
The USDM VAPs can decrease both validation time and validation costs by 50%, as well as provide for faster implementation time and better system performance.
Each template in the VAP lists requirements and tests for core and common system functionality. Among the functionality covered in our PLM VAPs are:
- Part 11 compliance (data security and integrity, e-signature, audit trail)
- Commonly used reports
- Change orders
- Manufacturing functionality
- Bills of Materials
- Routing
- Product costing
- Vendor and Customer lists
- Governance
To learn more about USDM and how we can assist with your compliance and business objectives, please contact:
Rebecca Meledy
888.231.0816 x161
775.213.5943 (fax)
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“Simplify, Unify and Optimize your business & compliance needs with USDM”
