In the wake of recent drug withdrawals, regulators are demanding proactive surveillance programs, including comprehensive risk management plan throughout a drug's lifecycle. Pharmacovigilance/safety systems allow collection, monitoring, researching, assessing and evaluation of information from healthcare providers and patients on the adverse effects of medications and biological products, and the reporting of adverse events to regulatory agencies.
USDM Life Sciences' pharmacovigilance/drug safety 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 pharmacovigilance/drug safety system 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 commercial pharmacovigilance/ drug safety systems. 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 Life Sciences 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 clinical systems VAPs are:
- System access and security
- Electronic signatures
- Audit trails
- Case handling
- Case registration
- Reporter information
- Patient information
- Drug information
- Adverse events
- Product reactions
- Alerts and notifications
- Regulatory agency reporting
Pharmacovigilance/safety systems supported by US Data Management Validation Packages:
- Oracle Argus
- Oracle Aers
- Aris Global
USDM Life Sciences works closely with Oracle to identify upcoming patches and updates, and provides a full maintenance program for our Oracle 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 Oracle 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 Oracle validation professionals can provide your organization with innovative and streamlined alternatives to industry standards.
USDM Life Sciences has been successful across many Oracle 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.