Services include:

• Assess, build and maintain Quality Systems for clinical phases in accordance with GCP regulations
• Perform QMS Gap Assessments including 21 CFR Part 11 Computer System Validation for development phase appropriateness
• Implement, validate and manage Electronic Document Management Systems/electronic Quality Management Systems (eQMS). This includes full review/approval of documentation as well as UAT/PQ execution to maintain project timelines and test functionality as a QA user.