12 Software Validation Subjects That Should Be Covered by Your QMS.
One of the primary challenges we encounter when embarking on a CSV (Computerized System Validation) or a QSA (Quality Software Assurance)...
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.