Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA

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Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA

Reviewed

January, 2024

Carolyn Troiano

Learning Objectives

To explain how to identify “GxP” Systems
To discuss the Computer System Validation (CSV) approach based on FDA requirements
To discuss the System Development Life Cycle (SDLC) approach to validation
To describe the importance of performing a thorough vendor audit to ensure oversight of the products and services they deliver
To discuss the key characteristics to review when performing an onsite vendor audit
To explain how to use a Vendor Questionnaire as part of a vendor audit
To discuss the best practices for documenting computer system validation efforts, including requirements, design, development, testing, and operational maintenance procedures
To describe how to maintain a system in a validated state through the system’s entire life cycle
To discuss how to assure the integrity of data that supports GxP work
To discuss the importance of “GxP” documentation that complies with FDA requirements
To discuss the policies and procedures needed to support your validation process and ongoing maintenance of your systems in a validated state
To discuss the key components of 21 CFR Part 11 compliance for electronic records and signatures
To discuss the regulatory influences that lead to FDA’s current thinking at any given time

Course Description

Computerized systems that are used in FDA-regulated environments (i.e., the system “touches” an FDA-regulated product, or a raw material or packaging component used in conjunction with the product during the manufacturing, testing, or tracking processes). Such a system must be validated by FDA guidelines for computerized systems and documented accordingly.

It is important to be able to identify computer systems used when performing FDA-regulated activities. When a vendor is involved, whether in terms of provisioning hardware and/or software, implementing the system, or maintaining it, this must be done in compliance with FDA requirements. A solid computer system validation strategy, along with an understanding of industry best practices, will lead your company to ensure that vendors are held accountable for the delivery of systems and services that will support your efforts to validate computer systems and maintain them in a validated state.

This CPE webinar will also guide you on the importance of factoring risk into all FDA-regulated activities and will help you assess the risk of any computer products purchased from third-party vendors.

Major topics covered in this Online CPE Webinar course on Information Technology:

A strategic approach to vendor audit
Key areas of vendor performance that are necessary to ensure they will meet your compliance requirements
How to investigate 21 CFR Part 11 (electronic records/electronic signatures) compliance
Procedural controls are needed to support areas where there may be technical control gaps or weaknesses
Ways to leverage your vendor’s experience and expertise to assist with Installation Qualification and Operational Qualification
How to carefully document all activities related to your vendor to ensure compliance
Best industry audit practices to ensure FDA compliance

Overview

FDA compliance

5 mins
Audit preparation

13 mins
Audit Execution

50 mins
Maintaining a system in a validated state

61 mins
Disaster recovery planning

82 mins

Webinar Qualifies For

1.5 CPE Credit of Information Technology for Certified Public Accountants (CPA-US)
1.5 General Credit of Information Technology for Accountant/Bookkeeper/Tax Professionals
1.5 CPE Credit of Information Technology for Certified Internal Auditors (CIA)
1.5 CPE Credit of Information Technology for Certified Fraud Examiner (CFE)
1.5 CPE Credit of Information systems for Certified Management Accountants (CMA)
1.5 CPE Credit of Risk-Based Audit Planning for Certified Information Systems Auditor (CISA)
1.5 CPE Credit of Information Technology for Certified Government Financial Manager (CGFM)
1.5 CPD Credit of System and Organization Controls Reporting for Certified Information Technology Professionals (CITP)
1.5 CPE Credit of Information Technology and Security for Certified in Risk and Information System Control (CRISC)
1.5 CE Credit of Information Technology (inc. Excel) for Certified FP&A Professional (FP&A)
1.5 CPE Credit of Information Technology for Iowa Licensed Public Accountant (IA-LPA)
1.5 CPE Credit of Information Technology for Maine Licensed Public Accountant (ME-LPA)
1.5 CPE Credit of Information Technology for Delaware Licensed Public Accountant (DE-LPA)

About Instructor

Carolyn Troiano

Account Executive, BrainStorm Central Consulting LLC

Carolyn Troiano has more than 35 years of experience in computer system validation and compliance in the pharmaceutical, medical device, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.

Additional Information

Duration

1.5 Hours

Course Level

Basic

Instructional Method

QAS Self Study

Pre-requisites

None

Advance Preparation

None

FAQ’s

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