Verification and Validation are key processes in the life cycle of a computerized system. The validation processes are mandated for regulated systems. Life Sciences organizations spend a lot of effort in making sure the system performs consistently to produce its pre-determined specifications and quality attributes.
Though the activities required to meet the regulatory requirements are well defined, the experience in designing and executing such processes are important in an organization to make this a standard and part of the overall organization need.
How can Navitas Solutions help?
A well experienced team in design and implementation of Verification & Validation are part of Navitas who can partner with organizations to implement such projects. The processes followed at Navitas are well-established and matured services framework for Verification & Validation.
Navitas has significant experience working with GxP and ICH guidelines. We understand the regulatory context and are driven by the desire to implement pragmatic approaches that meet compliance requirements. Our processes comply with all categories of GAMP Guidelines and we are able to perform qualifications at the Design, Installation, Operational and Performance levels.
Navitas has been a preferred service provider of Independent Verification & Validation services for the reasons described here:
- Domain expertise and a portfolio of service offerings in regulated industry
- Repository of test cases for 21 CFR Part 11 requirements
- Global delivery Model of local and offshore enabling rapid deployment
- Successfully performed multiple DQ/IQ/OQ/PQ
- Flexible resourcing model delivering greater value
- Advisory services to build processes for the organization
- Product / Application Testing Services
- Test Services for System, Regression, Migration and Performance
- Validation Services covering Platform & Application Levels
- Validation of systems to meet regulatory compliance requirements