The KOŚA Blog

Practical thinking on compliance, quality, and building the modern life sciences stack.

21 CFR Part 11

21 CFR Part 11: Requirements, Compliance and Best Practices for GxP Systems

A QA reviewer signs a paper batch record and the trail is right there. Ink, initials, a date scribbled beside

Data integrity in pharma

Data Integrity in Pharma: ALCOA Principles, Requirements and Best Practices

Pharmaceutical companies depend on accurate and trusted information to make important decisions in research, manufacturing, quality control and product release.

Best Pharma ERP Software for Pharmaceutical Industry

Best ERP Software for Pharmaceutical Industry: How to Choose the Right Solution 

What Is the Best ERP Software for the Pharmaceutical Industry? Pharmaceutical companies work with a smaller margin for error than

Pharma Learning Management System Features, Benefits and Compliance Guide

Pharma Learning Management System: Features, Benefits and Compliance Guide

Maintaining an educated pharmaceutical workforce becomes hard as SOPs change every few months and inspectors demand evidence, not just empty

Pharmaceutical Document Management

Pharmaceutical Document Management: A Complete Guide to Building a GxP-Compliant Document Management System

Walk into almost any pharma plant and the first thing you notice, honestly, is paper. Batch records stacked on a