21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

Learning Objectives

• To explain 21 CFR Part 11 and what is required for compliance
• To discuss industry best practices related to compliance and computer system validation
• To discuss the strategies for reducing the cost and complexity of compliance with FDA regulations, including 21 CFR Part 11
• To describe how the System Development Life Cycle (SDLC) methodology supports the computer system validation process

Course Description

There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.

It also requires very specific identification of users that ensures the person signing the record is the same person whose credentials are being entered and verified by the system.  The rule for changing passwords must be rigorously adhered to and the passwords must be kept secure.

The system must specify the exact meaning of the signature.  It may be that the person conducted the work, recorded the result, reviewed the result, or approved the result. 

A person may simply be attesting to the fact that they reviewed the work and the signatures, and there was appropriate segregation of duties (i.e., the person recording the result is not the same as either the person reviewing or the person giving final approval).

A company must have specific policies and procedures in place that explicitly state responsibilities and provide guidance for implementing and using ER/ES capability.  These must clarify the 21 CFR Part 11 regulation and provide insight as to the way the company interprets its responsibility for meeting it. 

As FDA continues to evolve and change due to the many factors that influence the regulatory environment, companies must be able to adapt. New technologies will continue to emerge that will change the way companies do business.  

While many of these are intended to streamline operations, reducing time and resources, some unintentionally result in added layers of oversight that encumber a computer system validation program and require more time and resources, making the technology unattractive from a cost-benefit perspective.

In this Online CPE webinar, speaker Carolyn Troiano will cover the key aspects of complying with 21 CFR Part 11 in both validating systems and maintaining them in a validated state throughout their entire life cycle.

Click here to access Online CPE webinars on Computer Software and Applications | Information Technology |

Overview

• FDA regulatory overisght

  4 mins
• 21 CFR part 11 overview

  11 mins
• 21 CFR part 11 compliance

  28 mins
• Data integrity

  52 mins
• System development life cycle (SDLC)

  65 mins
• Industry best practices

  84 mins