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


Auditing/Assessment

•Vendor Validation Audits

•Vendor Assessments

Validation

Equipment
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