Validation Packages
Life science companies must manage global compliance standards and accelerating performance expectations to maintain a competitive advantage in the industry. Companies are looking to decrease costs, accelerate time to market, increase productivity, while achieving, simplifying and maintaining compliance.Oracle and US Data Management (USDM) partner to provide a comprehensive solution to support FDA requirements for Oracle applications.
The USDM Validation Accelerator Packs (VAPs) provide life science companies with an industry best practice tool to simplify compliance, increase productivity and minimize costs. The USDM VAPs have been used successfully in the industry for over 8 years.
USDM’s VAPs for Oracle applications, including EBS, JDE, Agile, Siebel and the Clinical Suite of Products, combined with the Oracle Governance, Risk and Compliance (GRC) Manager provides an enterprise solution for achieving validation and maintaining a validated state across the enterprise IT platform. This combination enables validation best practices which help assure validation integrity and significant reduction in validation cost.
The USDM VAPs are a complete set of validation document templates for Life Science Oracle applications. The VAPs are 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 Oracle VAPs can decrease both validation time and validation costs by 50%, as well as provide for faster implementation time and better system performance. The VAPs provide an industry proven best practice approach to validation and compliance.
Services/Products:
- Agile VAP
- EBS VAP
- JDE VAP
- Siebel VAP
- Oracle Clinical VAP
- AERS VAP
- VAP Customization and Implementation
- GRC Consulting
- Compliance Services
Life science companies must manage global compliance standards and accelerating performance expectations to maintain a competitive advantage in the industry. Companies are looking to decrease costs, ...
In the life science industry, it is important that clients define and document a consistent approach for implementation and validation of computerized systems. A vast number of Standard Operating Proc...
USDM has been paving the way for life sciences companies to take advantage of the effeciencies of validation packages- for over a decade. As we reflect back on the journey to ensure a proper level of...
