Chief Pharmacist
Computer System Assurance
Computer System Assurance (CSA) refers to the comprehensive and systematic approach taken by organizations to ensure the reliability, security, and ...
CSV Qualification Summary Report
A Computer System Validation (CSV) Qualification Summary Report is a comprehensive document that provides an overview of the validation process ...
Difference Between 21 CFR Part 11 and Annex 11
21 CFR Part 11 and Annex 11 are both regulatory guidelines that provide requirements for electronic records and electronic signatures ...
What is a Non-GxP System?
Non-GxP systems do not affect product quality, patient safety, or regulatory decisions. Validation effort here is minimal or not required. ...
Determining GxP Relevant Software
Determining whether a software system is GxP (Good Practice) relevant in the pharmaceutical industry involves assessing its impact on processes ...
Software Development Life Cycle in Pharmaceutical Industry
In the pharmaceutical industry, the software development life cycle (SDLC) consists of several phases that ensure the proper development, validation, ...
URS | The Foundation of CSV
The User Requirements Specification (URS) defines what the user expects from the system from a business and compliance perspective, without ...
Is Coning Always a Problem?
One of the most common myths analysts come to me with is that coning is always a problem to be ...
New Biosimilar Era | FDA’s Biggest Shift
FDA has delivered the most consequential policy change in two decades, a shift that fundamentally transforms how our industry will ...
Common Technical Document (CTD)
The Common Technical Document (CTD) is one of the most significant harmonisation achievements in global regulatory science. Before CTD, every ...
Inspection Readiness | From Audit Week to Always-On
I have lost count of how many times I have seen teams go into panic mode the week before an ...
Understanding D50 in Particle Size Distribution of API – Why It Matters!
In pharmaceutical development, Particle Size Distribution (PSD) is a critical quality attribute—especially for Active Pharmaceutical Ingredients (APIs). Among the PSD ...