ECM

Enterprise Content Management (ECM) systems act as a controlled management system and repository for critical business documents. They manage such functions as document security, version control, document control and electronic approval processes across the enterprise.

 

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

We achieve this through:

  • Experience – a decade of ECM 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 (VAPs) for most standard ECM platforms -  These VAPs are a complete set of content-rich validation document templates for the system based on common, core 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 ECM VAPs are:

  • System access and security
  • File management
  • Records management
  • Document versioningWorkflows
  • Electronic signatures
  • Audit trails
  • Searches
  • Notifications
  • Reporting
  • Printing

USDM Life Sciences supports the following ECM applications:

  • Oracle Content Management
  • Open Text ECM
  • Alfresco
  • Generis CARA

USDM Life Sciences works closely with its partners and vendors to identify upcoming patches and updates, and provides a full maintenance program for our ECM VAP clients. Recommendations for required testing are made to ensure our clients an effective, efficient validation maintenance process.

USDM Life Sciences has a dedicated, experienced validation team that can customize the VAP templates and provide best practice consulting on regulatory compliance. 

Equipped with over 10 years of experience and specialization in regulated business processes, our skilled team of ECM validation professionals can provide your organization with innovative and streamlined alternatives to industry standards.

USDM Life Sciences has been successful across many ECM validation projects around the globe and our best-in-class validation services coupled with proven and effective methodologies can give your organization the competitive advantage it needs to thrive in today's regulated environment.

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    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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