Solutions / GMP
Good Manufacturing Practice under control
Ingenes Studio QMS supports regulated organizations with structured records, controlled workflows and traceability for GMP quality processes.
GMP areas supported by the platform
SOP and document control
Controlled documents, versioning, reviews, approvals and distribution.
Deviations and CAPA
Deviation registration, risk classification, root cause analysis and corrective actions.
Change control
Impact assessment, approvals, implementation tasks and effectiveness checks.
Training and competence
Training plans, SOP acknowledgement, competence matrix and training history.
Audits
Audit planning, checklists, evidence, findings and follow-up actions.
Audit trail support
Traceable history of important records, responsibilities and approvals.
Need a QMS for a regulated environment?
We will discuss how to configure Ingenes Studio QMS for your GMP process landscape.