Quality & Compliance
GxP Readiness and Auditing: Your Quality System’s Insurance Policy for Compliance Systems
In the world of pharmaceuticals, biotech, and medical devices, maintaining compliance with Good Practices (GxP) is critical to ensuring product safety, efficacy, and quality. But how do companies...
Quality & Compliance
What is GxP Compliance: A Detective’s Guide to Quality and Regulatory Compliance
Introduction In the brightly lit corridors, clean rooms, and warehouses of pharmaceutical and medical device industries, a mystery lurks—a puzzle shrouded in regulations, veiled in risk, and cloaked...
Clinical Research Solutions
Understanding GxP Compliance in Drug and Medical Device Development Lifecycle
In the complex world of drugs and medical devices, where every pill, syringe, and implant holds the potential to impact lives profoundly, ensuring the utmost safety, efficacy, and quality is...
Clinical Research Solutions
Value of Intentional Bias in GxP Vendor Audits
Discovering intentional bias in GxP Vendor audits: weighing its advantages, drawbacks, and strategies for effective mitigation. While the prevailing view suggests that GxP auditors should not be...
Clinical Research Solutions
Recognizing the Value of Outsourcing GxP Audits
In today's highly regulated pharmaceutical, biotechnology, and healthcare industries, maintaining compliance with GxP Practices, and other regulatory requirements is paramount. Failure to meet these...
Clinical Research Solutions
What You Need to Know About GxP Independent Compliance Audits, Part 2
Welcome to Part 2 of our blog series on "What You Need to Know About GxP Independent Compliance Audits." In Part 1, we discussed the importance of GxP audits, the different audit types, and why...
Clinical Research Solutions
What You Need to Know About GxP Independent Compliance Audits, Part 1
In this post, we’re going to discuss the various types of GxP Compliance Audits, internal versus independent third-party audits. the role that independent auditors play in conducting compliance...
Clinical Research Solutions
How to Implement an Effective Audit Trail
Maintaining an audit trail is a regulatory compliance requirement, but what makes an audit trail beneficial for maintaining effectiveness and complying with regulations? This blog will explain what...
Clinical Research Solutions
6 Quick Tips for Excel Spreadsheet Validation
Are you using Microsoft Excel spreadsheets for GxP activities? Are these Excel sheets used again and again, as a template? Ever thought about validating your spreadsheet templates? Is the person who...