Good Documentation Practices to Support FDA Computer System Validation

Course Description

Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing, and distribution of a product in the pharmaceutical, biotechnology, medical device, or other FDA-regulated industries. The FDA requirements ensure thorough planning, implementation, integration, testing, and management of computer systems used to collect, analyze and/or report data.

Electronic records and electronic signatures (ER/ES) came into play through guidelines established by FDA in 1997 and disseminated through 21 CFR Part 11. This code describes the basic requirements for validating and documenting ER/ES capability in systems used in an FDA-regulated environment.

In the early 2000s, FDA recognized they could not inspect every computer system at every regulated company and placed the onus on industry to begin assessing all regulated computer systems based on risk. The level of potential risk, should the system fail to operate properly, needed to be the basis for each company’s approach to developing a validation approach and rationale as part of the planning process. System size, complexity, business criticality, GAMP 5 category, and risk rating are the five key components for determining the scope and robustness of testing required to ensure data integrity and product safety.

In December 2018, FDA issued a guidance document on Data Integrity (DI), which has seen an alarming increase in DI issues during inspection of regulated firms. This upward trend continues and is of particular interest during FDA inspection.

In this CPE webinar, we will explore good Documentation Practices to Support FDA Computer System Validation.

Learning Objectives

• To discuss the requirements for documenting efforts related to systems governed by FDA.
• To discuss the best practices for documenting computer system validation efforts, including requirements, design, development, testing, and operational maintenance procedures.
• To review examples of incorrect, incomplete, or otherwise inappropriate and non-compliant documentation and understand why these are not acceptable.
• To analyze how to prepare a procedure that will capture the best practices for FDA compliant documentation.
• To discuss the importance of training as it relates to good documentation practices to ensure FDA compliance.

Recommended For

• This CPE webinar is recommended for CPAs, CISA, CISM, CRISC, and all the titles of ISACA who want to understand Documentation Practices to Support FDA Computer System Validation.
  

Who Should Attend?

Webinar Qualifies For

• 1.5 CPE Credit for Certified Data Privacy Solutions Engineer (CDPSE)
• 1.5 CPE Credit for Certified in Risk and Information System Control (CRISC)
• 1.5 CPE Credit for Certified Information Security Manager (CISM)
• 1.5 CPE Credit for Certified Information Systems Auditor (CISA)
• 1 CPE Credit of Information Technology for Certified Public Accountants (CPA-US)
• 1.5 CPE Credit for Information Technology Certified Associate (ITCA)

FAQs content