Professional Services
Technology Validation Support
Reduce the burden of system validation with Advarra’s expertise and resources. Our approach supports rapid implementation and ensures compliance with 21 CFR Part 11 through tools like Advarra eSource + EDC and Advarra eReg. By providing essential validation support, we help your organization achieve a centralized, validated state for your data and documents.
Key Services
- Experienced specialists
- Standard operating procedure (SOP) evaluation and documentation
- Testing documentation
- Validation plan and testing documentation
- Ongoing training and support
Holistic Validation Support
Compliant Foundation
We assess your policies and workflows to ensure they align with CFR 21 Part 11, guiding you in developing sustainable, validated processes.
Standard Process
Unique templates, SOPs, and configuration specifications are tailored to your organization’s needs, helping reduce validation time.
Ensure Upkeep
Continuous support through release impact assessments, risk analysis, and updated validation packets ensure long-term compliance with evolving system upgrades.
Validation Efficiency
Advarra’s Validation Packet includes key documents like the validation plan, traceability matrix, and test suite approvals to minimize testing burden.
Internalize Knowledge
Our training resources, including video modules and weekly meetings, ensure users fully understand and comply with SOPs for consistent system usage.
Community Benefits
Stay engaged with Advarra through product collaboration opportunities and the Onsemble community forum to influence future technology developments.
