Blog

Person Analysing Changes

Bruna De Lucca Caetano

Change Control in Pharma: Requirements and Process

Change ManagementPharmaceutical

Person identifies and registers a nonconformance on a piece of paper

Bruna De Lucca Caetano

Nonconformance: Definition, Types, Process, and Prevention

Nonconformance

Person Analyzing QMS Documentation Hierarchy

Bruna De Lucca Caetano

Quality Management System Documentation

QMS

Woman Completing the Checklist

Bruna De Lucca Caetano

SOP Management in the Pharmaceutical Industry

Pharmaceutical

Comparing FDA 21 CFR Part 11 and EU GMP Annex 11

Bruna De Lucca Caetano

FDA 21 CFR Part 11 vs EU Annex 11: What is the Difference?

21 CFR Part 11Regulations

EU GMP Annex 11 Compliant Computerized System

Bruna De Lucca Caetano

Annex 11: Computerized Systems (What You Need to Know)

Regulations

21 CFR Part 11 Common Questions and Answers

Bruna De Lucca Caetano

What is FDA 21 CFR Part 11? (32 Questions and Answers)

21 CFR Part 11

Person conducting applicability assessment

Bruna De Lucca Caetano

21 CFR Part 11 Applicability Assessment

21 CFR Part 11

Illustration of 21 CFR Part 11 Training Records Migration

Allan Murphy Bruun

21 CFR Part 11 and Training Records (What You Should Know)

21 CFR Part 11

Illustration of 21 CFR Part 11 Compliance Checklist

Allan Murphy Bruun

21 CFR Part 11 Compliance Checklist [PDF & XLS Download]

21 CFR Part 11

21 CFR part 11 Noncompliance With Exclamation Mark

Allan Murphy Bruun

21 CFR Part 11 Noncompliances (And How to Avoid Them)

21 CFR Part 11

21 CFR Part 11 Closed VS Open System

Allan Murphy Bruun

21 CFR Part 11 Open vs Closed System: What is the Difference?

21 CFR Part 11

15678