William Bellavance
What is CFR 21, Part 11 and does it apply to your organization?
In this blog, we explain "Part 11", the reasons that led to the need for this regulation, and the needs for following it.
top of page
COMPLIANCE TRAINING
Training program structure, refine training matrix to configure new learning management systems (LMS) & training support for employees.
COMPUTER SYSTEM VALIDATION
Aligned with GAMP 5 methodology, assisted computerized systems validation focused on medical devices, clinical research, pharma & laboratory work.
SYSTEM GAP ASSESSMENTS
Evaluation of enterprise resource planning (ERP) and quality management systems (QMS). Internal system appraisal and regulatory assessments.
INFRASTRUCTURE QUALIFICATIONS
Ensuring an adequate qualified GXP cloud-based or on-premises applications, infrastructure verification & technology stack control systems.
IT POLICIES & PROCESS DEFINITIONS
Develop & implement procedural controls
for establishing proper governance of
your technological assets.
BLOGS & ARTICLES
Search
bottom of page