Validation Packages for ECM SystemsEnterprise 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’s 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 Supports the following ECM applications:
