Compliance with FDA's 21 CFR Part 11 Guidance for Electronic Records and Signatures (ER/ES)

Event Information
Product Format
Prerecorded Event
Presenter(s)
Conference Date
Mon, Oct 23, 2017
Length
60 minutes
Product Description

Best Practices and Strategies for 21 CFR Part 11 ER/ES Compliance and Computer System Validation

FDA’s 21 CFR Part 11 was enacted in the late 1990s, however implementation success across the pharmaceutical and other regulated industries has been mixed. There are specific limitations that arise when using electronic record/electronic signature (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 specific identification of users to ensure the person signing the record is the same person whose credentials are being entered and verified by the system. It is also critical that the system specifies 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). Companies must also rigorously adhere to the rules for changing passwords and must keep the passwords secure.

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 regulations and provide insights regarding the way the company interprets their 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, which 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.

Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. During the past 30 years, best practices that have been developed will ensure that validation activities are cost-effective while meeting all aspects of FDA compliance.

Join this session with expert speaker Carolyn Troiano, who will focus on the importance of ensuring that ER/ES capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.

Session Highlights

  • Computer system validation (CSV) and the system development life cycle (SDLC) methodology
  • Good “variable” practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))
  • Validation strategy that will take into account the system risk assessment process
  • FDA’s 21 CFR Part 11 (electronic records/electronic signatures) guidance
  • Strategic approach to ER/ES compliance
  • Policies and procedures to support GxP compliance with 21 CFR Part 11
  • Training and organizational change management best practices to help move the organization in a new direction
  • Industry best practices and common pitfalls

Session Objectives

With this session, you will learn:

  • What is required for compliance with 21 CFR Part 11
  • Industry best practices related to compliance and computer system validation
  • Strategies for reducing the cost and complexity of compliance with FDA regulations, including 21 CFR Part 11
  • How the SDLC methodology supports the computer system validation process
  • How to effectively document the process of computer system validation, and maintain current information about the various systems in your organization and how they are maintained in a validated state
  • How to gain information about trends in validation, as industry progresses and new best practices emerge
  • Some of the industry best practices to apply when following the SDLC methodology

Who Should Attend

  • Information technology analysts
  • QC/QA managers
  • QC/QA analysts
  • Clinical data managers
  • Clinical data scientists
  • Analytical chemists
  • Compliance managers
  • Laboratory managers
  • Automation analysts
  • Computer system validation specialists
  • GMP training specialists
  • Business stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance and audit
  • Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
  • Auditors engaged in the internal inspection of labeling records and practices

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Carolyn Troiano - FDA Regulation Expert

Carolyn Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs.


Carolyn has spent a number of years evaluating supply chain security and compliance, including technologies...   More Info
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