Our experienced staff meets all your validation needs. The Verista resources bring subject matter expertise to computer system validation initiatives.
Our resources have the training, knowledge, and industry experience to validate systems, as well as maintain the validated state during the operational phase.
The Enterprise IT Service Line supports the validation of business and mission critical information systems across multiple domains including: Research & Development, Clinical, Regulatory, Safety, Quality Manufacturing, and Enterprise Level Information Systems.
Our Business Analysts and Validation Engineers provide support throughout the system and validation lifecycles; from concept, planning, business process analysis, specification development, build / configuration, testing, production release, and operational change management. Our resources will collaborate with the client to develop the relevant procedures, assist with operational change and incident management activities, perform periodic reviews to ensure the system continues to operate in a validated state, and support re-validation efforts when necessary.
Infrastructure and their related services are the foundation for all Business applications. The control and management of a company’s infrastructure ensures that the backbone of all applications is being maintained consistently and in a controlled manner. Verista’s Infrastructure Solutions also ensure that Security and Service Management are built into all application environments.
Information System & Data Integration
Our Validation Engineers partner with client stakeholders to identify system and data integration requirements, define specifications, and conduct verification activities to ensure the integration is performing according to specifications.
Our Project Managers possess the experience to effectively manage your project from planning through production release. We’re committed to maintaining a high level of quality and compliance, with budget and timeframe considerations at the forefront.
Verista’s Validation Engineers can provide support throughout the data migration process, including: analyzing legacy data, remediating data quality issues, preparing data migration plans / test plans, and conducting data verification activities.
Our team has extensive experience with Planning, Executing, and Managing Legacy Computer Validation, 21 CFR Part 11 / Annex 11 Gap Analysis and Remediation programs, as well Data Integrity programs.
Here is a sampling of the types of systems we support:
- Clinical Trial Management Systems
- Regulatory Information Management Systems
- Enterprise Resource Planning (ERP) Systems
- Quality Management Systems
- Customer Relationship Management Systems
- Learning Management Systems
- Document Management Systems
- Pharmacovigilance and Safety Monitoring Systems