It Takes Professional Service

B2Solutions Services include, but are not limited to:

Business Analysis and Implementation

•Business Requirements Definition

•Project Management

•Functional Requirements Definition

•SOP Development

•Configuration Management

Validation Services

•GxP Compliance

•21 CFR Part 11


•Vendor Validation Audits

•Vendor Assessments


Cycle Development
• Executing and Summarizing IQs, OQs, and PQs for GMP Production Equipment, such as:
• Sector Imagers
• Molecular Devices
• Controlled Temperature Units (CTUs) - Refrigerators, Freezers, Incubators and Finished Product Warehouses
Environmental Systems
• Environmental Monitoring
• HVAC Systems

System LifeCycle

Risk Based Approach to Validation
• Validation Master Plans
• Requirements Traceability Matrix
• IQ/OQ/PQ Development/Execution
• SOP Creation

Project Management

Project Planning
•Development and implementation of Project Plans consistent with client timeline and budgetary goals
System Owner Services
•Business Analyst Services (URS/FRS development)
•Vendor Assessment/Audits