Staffing and Consulting
What OneUS Technologies ProvideS
- End-to-end validation services for Enterprise, Manufacturing, Lab, R&D, IT systems, equipment/instruments.
- Cloud systems validation and vendor upgrade management
- QMS : CAPA, Periodic Review governance, Procedure improvements
- QMS audits (supplier, internal)
- Team building
- Data Integrity Assessment (DI - ALCOA and ALCOA+)
- FDA regulations, Annex 11 – EU regulations
- Project, Program Management
- Computer System Validation/Assurance (CSV/CSA)
- Software Quality Assurance
- Application and Infrastructure qualification
- Test strategy development
- Resource planning
- Mentoring
- Client relations
- Vendor relations
- Process improvements
Client Challenges
- · Limited Resources for CSV/CSA and Software Quality Assurance activities
- · Existing resources are committed to other activities
- · Out of compliance with regulations
- · Challenges in identifying the right tools for Testing, Document Management, System Inventory, and Change Control Management)
- · No established Validation Program
Business Value
Partners its clients to provide comprehensive Ancillary Services that offer numerous business benefits such as:
- Access to the right information at the right time
- Increased operational efficiency and effectiveness
- Improved governance mechanism
- Risk mitigation and effective compliance with regulatory requirements