QA Edge leverages the industry’s most knowledgeable and experienced professionals in providing our clients the advantage needed in meeting today’s regulatory requirements.  The following lists our consultant types and a description of their skill sets.

Consultant Types Services/Activities Lead Validation Consultant Project management URS authoring and requirements gathering (testable requirements, Part 11 requirements) Risk Assessments Client SOP analysis and validation planning Validation/Test documentation Compliance monitoring, measurement and reporting (independent monitoring and review) SOP creation, review and roll-out. Senior Validation Consultant Project management (complex systems) Validation planning (complex systems) Risk Assessments Software Q/A audit Project audits Vendor Q/A audits URS authoring and requirements gathering (testable requirements, Part 11 requirements) Senior Testing Coordinator May augment a Lead Consultant on larger projects. Test plan/protocol creation Test script creation (manual and automated) Test script execution and defect management Test script editing and review (pre-existing) Deployment of automated testing tools Junior Testing Coordinator Regression testing (execution of pre-developed scripts) & defect reporting Technical Writer Creation of training materials Creation of user manuals SOP review (style) Trainer Creation of training materials Delivery of training TrackWise®-Certified Consultant Identifies CAPA requirements and tactics for using TrackWise Develops a Quality Plan, Project Management Charter and a Work Breakdown Structure (WBX) to optimize implementation resources and schedule Develops SOPs and supporting processes which incorporate best practices and minimizes bureaucracy Executive Consultant Project Management (complex projects) Validation Master Planning Training (Computer Validation Boot Camp, SOP’s, Part 11, GXPs, etc.) Client Strategy Meetings