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.
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.
REGULATORY POETRY OF THE WEEK
Life sciences is a serious environment where, as Patch Adams would probably agree, a bit little bit of humour can go a long way.
With this project, we hope to put a smile on GxP professionals and neophytes alike. The regulatory poetry entries are inspired by classics and real life experiences.
Please let us know your favorites!