Ofni Systems presents at numerous conferences and workshops on Part 11 and regularly conducts training sessions for organizations to educate employees about the specific requirements of the rule and how to incorporate it into daily practices.

Let Ofni Systems make knowledge management simple for you. Contact us today for for more information about these events.

2008

Validation of MS Access Databases published by askaboutValidation.com
Published June 2008

"This article will present a simple method for validating MS Access databases for GXP use. The goal of our validation strategy is to provide better testing and documentation of individual databases in less time. Once we establish this methodology, we can rapidly apply it to many databases to reach compliance faster.

This article will cover the most common examples of database validation activities. We will cover special or very complicated examples whenever possible, but anything not explicitly covered in this article can be added as needed to fit your existing validation requirements or for special cases."

Validation of MS Excel Spreadsheets published by askaboutValidation.com
Article of the month for May 2008

"This article will present a simple method for validating MS Excel spreadsheets for GXP use. The goal of our validation strategy is to provide better testing and documentation of individual spreadsheets in less time. Once we establish this methodology, we can rapidly apply it to many spreadsheets to reach compliance faster.

This article will attempt to cover the most common examples of spreadsheet validation activities that we find. We will attempt to cover special or very complicated examples whenever possible, but it should be understood that anything not explicitly covered in this article can be added as needed to fit your existing validation requirements or for special cases."

2007

Audio Seminar - Validation and Use of MS Access Databases in GxP and Part 11 Environments
August 23, 2007
11:00 EST

"Access databases are a simple way to meet many of the data collection and record keeping requirements required by the FDA but they also need to meet the technical requirements of 21 CFR Part 11, Electronic Records, Electronic Signatures. Out-of-the box Access has not been designed for regulated environments. This event will show you how to make Access databases Part 11 compliant."

Registration/Order Recording

2006

Journal of Validation Technology® Volume 12, Number 4, August 2006

Using Automation To Generate Validation Documents And Add Part 11 Compliance
The author has created software that automates the validation of computer software systems and generates validation documentation. This article will take you through the step-by-step process of how that process can be applied. The system can also be used to track the system's functional requirements over the life of the system. See how such a system may be of use in its many applications in your environment.

Training Course - Part 11 Compliance for MS Access
"Building 21 CFR Part 11-Compliant Applications"
Presented by FDA News and Ofni Systems
Raleigh, NC
March 30-31, 2006

WebEx Seminar - MS Access & Part 11: A Visual Presentation
Presented for the Clinical Device Group
February 16, 2006
11:00-12:30 CST

2005


2nd Annual FDA Information Management Summit at the Bethesda Hyatt
Bethesda, MD
November 30 - December 2, 2005

IVT Laboratory Regulations, Controls & Compliance
Nov. 29 – Dec. 2, 2005
Carolina, Puerto Rico

2004

DIA 40th Annual Meeting
June 13-17, 2004
Washington Convention Center
Washington, DC

Best Practices for Risk Management and 21 CFR Part 11 Compliance for Electronic Records
GCP Compliance
April 19-22, 2004
Washington, DC

Abstract

Tyson M. Mew, President, Ofni Systems Inc.
I. Interactive Exercise: Performing Risk and Compliance Assessments
• Build a risk assessment program
• Deciding where and how to assess risk
• Part 11 gap analysis
II. Collecting and Analyzing the Results
• Best practices in collecting and quantifying results
• Deciding where and how to assess risk
• Part 11 gap analysis
III. Corrective and Preventive Actions: Remediation Plans
• Deciding what priority to address first
• Tracking progress

Ensuring Access Databases and Excel Spreadsheets are Part 11 Compliant
IVT Laboratory Controls & Compliance
March 29- April 1st of 2004
Amsterdam, The Netherlands
NH Grand Hotel Krasnapolsky

Abstract

Workshop E • 8:30 am – 12:00 pm
– Dr. Dirk Bissinger, Industrial Operations Drug Products, Quality Assurance Manager, Aventis Pharma Deutschland GmbH
– Ty Mew, President, Ofni Systems Inc.
– Mary Chris Easterly, Technical Manager, QA Validation, Diosynth
– Derek Wimmer, President, Wimmer Systems, LLC.
– David Harrison, Senior Consultant, ABB Eutech.
This seminar presents how to design, build, and validate Access® databases and Excel® spreadsheets in accordance with current practices, including 21 CFR Part 11.

I. Ensuring Access Databases are Part 11 Compliant
• Databases for Part 11 compliance
• Technical controls and functionality
• Securing the Access® environment
• Procedural controls required to be implemented
• Validation of Access® programs
• Demonstrations and case studies

II. Compliance Controls and Excel®- Technical Aspects
• Strengths and weaknesses of Excel®
• How workflow concepts affect design decisions
• Analysis of controls for auditing, authenticity, security, etc.
• Ensuring your solutions will do what you want

III. Risk-Based Validation of Excel® Spreadsheets
• The challenges of validating Excel® spreadsheets
• Integrating Excel® validation into your current CSV practice
• Balancing risk-based validation with efficiency
• Resource requirements, and key learning points for Excel® validation projects

IV. Case Study of Aventis' Use of Excel® Spreadsheets and Preparing and Passing a FDA Inspection
• A pragmatic approach to excel spreadsheet validation
• A general approach on how to get prepared for an inspection
• Strategies for inspections - for inspectors and industry personnel

V. Interactive Exercise
This exercise will be an open question and answer forum for discussing issues related to making Access® databases and Excel® spreadsheets compliant.

2003


How To Make MS Access Programs Part 11 Compliant (audio conference)
October 28, 2003 1:30 PM EST
Download Sample Code References

Abstract

"Firms using Microsoft Access databases for record keeping as part of GxPs need to take the necessary steps to ensure that they are Part 11 compliant.  Part 11 demands that you address both technical and procedural requirements. This conference will detail technical controls that must be added, establishing a secure MS Access program, procedural controls that must be implemented and validation. The tools and information provided in the session will benefit anyone who needs to know how to make their systems compliant, as well as those charged with maintaining the integrity of their firm’s critical data. Attendees can also download free code samples that they can use in their own programs."

Ensuring Access Databases and Excel Spreadsheets are Part 11 Compliant
Laboratory Controls and Compliance Conference
August 18-21, 2003
Short Hills, NJ
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