Updates to Regulatory Guidelines - What's New in ISPE GAMP®5's 2nd Edition?
The new GAMP Guidance is a must-read. Find out what changed and our first impressions of this new edition.
Training program structure, refine training matrix to configure new learning management systems (LMS) & training support for employees.
Aligned with GAMP 5 methodology, assisted computerized systems validation focused on medical devices, clinical research, pharma & laboratory work.
Evaluation of enterprise resource planning (ERP) and quality management systems (QMS). Internal system appraisal and regulatory assessments.
Ensuring an adequate qualified GXP cloud-based or on-premises applications, infrastructure verification & technology stack control systems.
Develop & implement procedural controls
for establishing proper governance of
your technological assets.