Informatics Outsourcing provides full and incremental validation services for Clinical and Safety Data Management Systems. Our clients include large pharmaceutical companies. Our wide product knowledge, industry experience and understanding of regulative requirements change us to provide superior validation consulting services.
Overview of Validation
Validation demonstrates documented manifest furnishing a high degree of assurance that a specific computerized process or operation will consistently produce a quality of result assembling its predetermined specifications. The most important thing is document that a system systematically does what it is intended to do.
Informatics Outsourcing provides full validation services including but no limited to the following:
• Validation Project Management
• Validation Requirements Consulting
• Test Script Development
• Test Script Execution
• GAP Analysis
• SOP development
• SOP review
• Post Validation Implementation Services
The Validation Process
The validation process generally follows a System Development Life Cycle (SDLC) methodology and generates a set of documents that show the system is performing according to its design specifications.
Capabilities in Data Validation include,
• Design and development of Data Validation/ Verification plan
• Plan for checks on inconsistency and missing data
• Usage of validated electronic and manual checks on the database
• Resolution of queries that arise during the process