Quality KPIs in the Pharmaceutical Industry
Key Performance Indicator (KPI) is a measurable value that shows the progress in meeting a...
Quality KPIs in Life Sciences (Quality KPI & Metric Examples)
Key Performance Indicators (KPIs) are quantifiable measures of progress towards a specific goal....
Nonconformance Report (NCR): Definition, Example, and Process
Nonconformance is an event in which a product, service, or process does not meet the established...
Change Control in Pharma: Requirements and Process
Change control in the pharmaceutical industry is a systematic approach to managing product,...
Nonconformance: Definition, Types, Process, and Prevention
Nonconformance means that there was an event with a process, service, or product, and the result...
Quality Management System Documentation
QMS documentation discussed in this article are documents and records related to compliance and...
SOP Management in the Pharmaceutical Industry
Standard Operating Procedure (SOP) is a document that provides directions on how tasks and...
FDA 21 CFR Part 11 vs EU Annex 11: What is the Difference?
FDA 21 CFR Part 11 and EU GMP Annex 11 address similar concerns and aim to achieve the same goals,...
Laboratory Quality Management System (LQMS)
A Laboratory Quality Management System (LQMS) refers to a set of policies, procedures, and...
ICH Q10 Pharmaceutical Quality System (and Role of an eQMS)
The ICH Q10 Pharmaceutical Quality System (PQS) is a guideline that outlines a model for an...