Overview:
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. Rule for changing passwords must be
rigorously adhered to and the passwords must be kept secure.
It is critical that the system 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
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 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.
This webinar 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.
Why you should Attend:
This webinar will help you understand in detail the application of FDA’s
21 CFR Part 11 guidance on electronic records/electronic signatures
(ER/ES) for computer systems subject to FDA regulations.
This is critical in order to develop the appropriate validation strategy
and achieve the thoroughness required to prove that a system does what
it purports to do. It also ensures that a system is maintained in a
validated state throughout its entire life cycle, from conception
through retirement.
ER/ES capability can vary, and the approach should be based on the
specific case and the risk of failing to meet the guidance associated
with it.
Areas Covered in the Session:
- Learn about 21 CFR Part 11 and what is required for compliance
- Learn about industry best practices related to compliance and computer system validation
- Understand strategies for reducing the cost and complexity of compliance with FDA regulations, including 21 CFR Part 11
- Understand how the System Development Life Cycle (SDLC) methodology supports the computer system validation process
- Understand 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
- Learn about Data Governance and Data Integrity, including the FDA’s Guidance issued in late 2018
- Understand what it takes to audit a vendor of hardware, software, components and services
- Learn how to gain information about trends in validation, as industry progresses and new best practices emerge
- Understand some of the industry best practices to apply when following the SDLC methodology
- Q&A
Who Will Benefit:
This webinar is intended for those working in the FDA-regulated
industries, including pharmaceutical, medical devices, biological,
animal health, and tobacco. Functions that are applicable include
research and development, manufacturing, Quality Control, distribution,
clinical testing and management, adverse events management, and
post-marketing surveillance.
You should attend this webinar if you are responsible for planning,
executing or managing the implementation of any system governed by FDA
regulations, or if you are maintaining or supporting such a system.
Examples of who will benefit from this webinar include:
- Information Technology (IT) Analysts
- IT Developers
- IT Support Staff
- QC/QA Managers and Analysts
- Clinical Data Managers and Scientists
- Compliance Managers and Auditors
- Lab Managers and Analysts
- Computer System Validation Specialists
- GMP Training Specialists
- Business Stakeholders using Computer Systems regulated by FDA
- Regulatory Affairs Personnel
- Consultants in the Life Sciences and Tobacco Industries
- Interns working at the companies listed above
- College students attending schools and studying computer system
validation, regulatory affairs/matters (related to FDA), or any other
discipline that involves adherence to FDA regulatory requirements