ERP

Enterprise Resource Planning (ERP) Systems act as a modular source of automation for all core functions of an organization. Finance, product lifecycle management, supply chain management, warehouse management, customer relationship management, sales order processing, and human resources management are all potential functions of an ERP system. 

Most ERP systems are built in a modular fashion, allowing implementation of one or many of the potential modules. Given the complexity of an ERP system, these are by far the most time intensive and comprehensive systems to implement.

USDM Life Sciences' ERP system implementation practice focuses on rapid deployment, improved quality and reduced / risk-based validations for all of our engagements.

We achieve the above by using the following methods:

  • Experience – A decade of ERP installation and validation projects.
  • Risk-based approach to validation – A tried and tested method where the focus of the validation is on critical functions and modules that impact compliance data.  All other functions that indirectly affect compliance data are minimally tested.  This is documented in a detailed Risk Assessment.
  • Validation Accelerator Packs for most standard ERP Platforms -  These VAPs are a complete set of validation document templates for the system based on common, general requirements for life science companies.

The VAP difference:

Each VAP lists requirements and tests for core and common system functionality and can be leveraged to build the validation documentation suite.  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.

Among the common functionality (modules) covered in our ERP VAPs are:

  • Supply chain management
  • Part 11 (data integrity and security, e-signatures, audit trails)
  • Purchasing
  • Manufacturing and distribution
  • Lot traceability
  • Resource Planning
  • Order to cash
  • Inventory
  • Customer relationship management
  • Vendor management
  • Workflow management
  • Cost management
  • Quality Control

Testimonials

  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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