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.
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 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.
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.
You should attend this seminar if you are responsible for planning, executing, or managing the implementation of any system governed by FDA regulations that use ER/ES capability, or if you are maintaining or supporting such a system.
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.
There is an enormous body of documentation and information available that can be overwhelming. This course will provide a condensed overview of the key practices that deliver the best results by directing the attendees to the most critical and cost-effective methods, techniques, and tools available.
Upon completion of this session, attendees will have an understanding of how to:
Anyone who is involved in the development, testing, manufacturing, storage, handling, and distribution of products must understand and conform to FDA requirements for data quality and integrity.
Finally, anyone who is developing and maintaining software used in these industries should be aware of the requirements for data integrity for their systems.
You should attend this seminar if you are responsible for planning, executing, or managing the implementation of any system governed by FDA regulations that use ER/ES capability, or if you are maintaining or supporting such a system.
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.
There is an enormous body of documentation and information available that can be overwhelming. This course will provide a condensed overview of the key practices that deliver the best results by directing the attendees to the most critical and cost-effective methods, techniques, and tools available.
Upon completion of this session, attendees will have an understanding of how to:
Anyone who is involved in the development, testing, manufacturing, storage, handling, and distribution of products must understand and conform to FDA requirements for data quality and integrity.
Finally, anyone who is developing and maintaining software used in these industries should be aware of the requirements for data integrity for their systems.
Carolyn Troiano
Carolyn Troiano has more than 35 years of experience in computer system validation 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. She is currently building an FDA computer system validation compliance strategy at a vapor company. Carolyn has participated in industry conferences, and is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area. Carolyn also volunteers for the PMI’s Educational Fund as a …
Writing Techniques for Auditors and Risk Management Profess…
Transforming Anger And Conflict Into Collaborative Problem …
Unlock Employee Loyalty: Stay Interviews Will Keep Them Eng…
Stop Letting that Difficult Person Ruin Your Day - Effectiv…
Handbook Overhaul 2026: Compliance, OBBB Act & Beyond
Introduction to Microsoft Power BI Dashboards
Managing Difficult Employee Conversations
ChatGPT for HR - Build HR Policy Framework and Strategy
Independent Contractor vs. Employee - 2026 IRS Guidance on …
Stop Conflicts Before They Become Big Problems: Practical S…
Virtual and In-Person Onboarding Your New Hire: Policies, P…
Setting SMART Goals & Leveraging Storytelling for Reporting
Major Changes in W2 and 1099 for 2026 Compliance! Learn How…
Female to Female Hostility @Workplace: All you Need to Know
Rewiring Your Emotional Triggers: Leading with Clarity and …
I-9 Audits: Strengthening Your Immigration Compliance Strat…
Electronic Payment Fraud Prevention Best Practice
Onboarding Best Practices for Millennial and All Employees
From Spreadsheet Logic to Analytics Logic: Excel → Power BI…
Mastering the Prompt: How Every Professional Can Use AI to …
Batch Record Review and Product Release
Managing Toxic & Other Employees Who Have Attitude Issues
Emotional Intelligence: Mastering the Emotions of Great Lea…
FDA QMSR Explained: How the QMSR Replaces the QSR
ChatGPT for CPAs and Finance Professionals
2-Hour Virtual Seminar on How to Conduct an Internal Harass…
Project Management for Non-Project Managers - How to commun…
Leading a Project and Team in Stressful Times: Supporting y…
Excel - Pivot Tables - The Key To Modern Data Analysis and …
Better Business Writing-How to Write Right
HR Metrics and Analytics 2026- Update on Strategic Planning…
Excel + AI: The Smart User's Guide to Faster, Easier Work w…
4-Hour Virtual Seminar on Secrets of Psychology - Why Peopl…
Accounting For Non Accountants : Debit, Credits And Financi…
Thriving in a Hybrid Workplace: Keys to Leadership and Team…
Conquer Toxic People - Learn To Protect Yourself And Get Yo…
FDA Regulation of Artificial Intelligence/ Machine Learning
Beyond Orientation: Build a Strategic Onboarding Experience…