Tag: QMS

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Complaint management and investigation in GMP focusing on risk-based governance, escalation, CAPA linkage, and compliance oversight.

Complaints Management in the Pharmaceutical Industry

Practice-oriented guide to pharmaceutical complaint management: definitions, risk-based triage, investigations, CAPA, recall interfaces, and trending KPIs....
Good Documentation Practice (GDocP) in GMP, highlighting the role of structured, controlled documentation in ensuring data integrity, regulatory compliance, and trustworthy pharmaceutical records.

Good Documentation Practice (GDocP) in Pharma

A practical guide to Good Documentation Practice (GDocP) in pharma, covering ALCOA++, data integrity, inspections, electronic records, and compliance controls....
FY 2025 FDA inspection observations visual – quality audit and compliance review with executive hands analyzing reports and regulatory data.

FY 2025 FDA Inspection Observations: Quality Maturity in Drug and Medical Device Manufacturing

FY 2025 FDA inspection observations reveal recurring weaknesses in drug and medical device manufacturing, highlighting quality maturity, governance, and lifecycle...
Electronic Quality Management System eQMS

Electronic Quality Management Systems – eQMS

Optimize compliance and quality control in the pharmaceutical industry with eQMS (Electronic Quality Management System). Streamline documentation, enhance regulatory adherence,...
GDP Warehouse and man with forklift

Good Distribution Practice – GDP in the Pharmaceutical Industry

Elevate pharmaceutical supply chain integrity with Good Distribution Practice (GDP). Ensure quality, safety, and compliance in every step....

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