Articles

CSA (Computer Software Assurance) A move from Traditional CSV

FDA’s Draft Guidance on Computer Software Assurance for Manufacturing, Operations and Quality System Software has emphasized on ‘Critical Thinking’ to be a crucial part while implementation of automated systems. In brief it is a paradigm shift from document focused computer system validation practices to critical thinking assurance practices. The industry and the FDA are...

AmpleLogic: Proffering Benefits and Maximum Quality at Minimal Cost

As digitalization has become inevitable, to fulfill their unique automaton requirements, businesses are either developing their software the traditional way or opt for ready-to-use software, which is touted to be cheap, but succumbs hefty monies for modification. On the other hand, besides consuming a dismal amount of money, the trample of traditional software development...

AmpleLogic: Offering GMP QMS to Achieve Optimum ROI

The aging population, chronic and lifestyle diseases, emerging-market expansion, and treatment and technology advances are expected to spur life sciences sector growth in 2015. Furthermore, efforts by governments, health care providers, and health plans to reduce costs, improve outcomes, and demonstrate value is dramatically altering the health care demand and delivery landscape. The Pharma...

GAMP 5 Categories, V Model and 21 CFR Part 11, EU Annex 11

What is GAMP 5? Good Automated Manufacturing Practice, Founded in 1991. International Society for Pharmaceutical Engineering (ISPE) sets the guidelines for manufacturers and the current Version is GAMP 5. GAMP describes a set of principles and procedures that help ensure that pharmaceutical Software (Like QMS software, LMS software, DMS software etc.) has required quality....

Root Cause Analysis with example for "5" Why technique

Root Cause Analysis (RCA) is a method that is used to address a problem or non-conformance in the quality process to get to the “root cause” (actual cause of origin) of the non-conformity. RCA helps to correct or eliminate the cause and prevent the problem from recurring (preventive action). Root cause analyses is aimed...