Pharma Specialists

Automation

Audit Trails in Computerized System Validation (CSV)

Audit trails are a critical component of Computerized System Val…

November 04, 2024

Automation

GAMP V-Model to SCRUM | CSV Refresh

GAMP Good Automated Manufacturing Practice (GAMP) is a set of gu…

July 25, 2024

Automation

Software as a Service (SaaS) Validation in GxP Regulated Companies

Some SaaS providers claim their software is fully validated. Tha…

August 02, 2023

Automation

Digital Transformation in Pharma Companies

A key component of the Pharma 4.0 revolution, automation can tra…

July 22, 2023

Automation

Risk-Based Approach for Computer Systems Validation

GxP regulated companies are expected to adopt a risk-based appro…

April 26, 2023

Automation

Computer System Validation (CSV) to Computer Software Assurance (CSA)

Following the launch of their ‘Case for Quality‘ initiative in 2…

February 11, 2023

Automation

Computerized System GxP Requirements | Standard Checklist

It would be impossible to list all the documents GxP could req…

January 23, 2023

Automation

GAMP 5 Guidelines for Computerized System Validation

Computerized System A broad range of systems including, but no…

September 25, 2022

Automation

Computer Software Assurance for Production and Quality System Software

FDA is issuing this draft guidance to provide recommendations on…

September 23, 2022

Automation

Introduction to ISPE GAMP 5 Guide

ISPE GAMP 5 Guide for Pharmaceutical Industry This revision of…

September 21, 2022