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E-book  on Compliance IQ

5 Steps to improving your Compliance IQ

Managing compliance in a highly regulated environment is a daunting task.  The ever-shifting compliance and quality management landscapes can make keeping up a full-time job!  

With this E-book you can learn 

  • How to maintain state of compliance
  • How to minimize risk
  • How to increase overall productivity


E-book Preview

Xybion Corporation © 2017
compliance E-book

Master Good Documentation Practices (GDP)

Understand the Key Differences between Quality Assurance and Quality Control

Understand Quality by Design (QbD) and the Regulations which Support it

Understand the Key Differences between GLP vs. GCP vs. GMP

Understanding IT Governance and Regulatory Compliance

ComplianceBuilder is a flexible compliance software solution designed to provide real-time monitoring of 21 CFR Part 11. By generating audit trails and providing configurable electronic signatures, ComplianceBuilder allows you to securely track changes across all IT subsystems including file systems, databases and laboratory equipment. It can be configured to monitor any file-based system for changes,including additions,deletions, and file modifications. This is accomplished through a security wrapper that can be placed around the application and file storage area and by monitoring file changes, including file creation, deletion or modification

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