COURSE DESCRIPTION

OVERVIEW

Validation of computer systems is a legal requirement within the pharmaceutical, biotech, and medical device industries.  Given the current regulatory and industry focus on electronic data integrity, adequate control over electronic data systems is coming under more scrutiny.  Quality personnel are often tasked with auditing and/or reviewing computer systems validation packages, whether for internal business groups or outsourced businesses that collect or generate regulated data on behalf of the sponsor firm.  Technical management, principal investigators, study directors, and similar personnel can also be tasked with reviewing the adequacy of a system’s validation status prior to approving its use on a regulated activity, but what are the critical items to look for?

The purpose of this training is to present techniques and strategies for auditing computer systems validation documentation for compliance to applicable global regulations, plus internal policies and SOPs.   Current issues including cloud systems and data integrity will be discussed.

LEARNING OBJECTIVES

1. A review of regulatory requirements for computer systems validation
2. Understanding the basic components of a computer systems validation package
3. Identify high-risk areas within a computer systems validation project
4. Identify where to look in documentation for evidence of specific testing of critical system functions
5. Learn how to audit change control and periodic review documentation to help assure the maintenance of the validated state
6. Strategies for reporting and mitigating issues identified
7. Common mistakes and pitfalls to avoid when auditing your systems