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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.

Upcoming Events

Spreadsheet Validation: 21 CFR Part 11 Compliance

Software intended for the management of manufacturing processes and FDA submissions may very well be too complex, expensive, and laden with features unnecessary in your environment. Commonly available spreadsheet programs like MS Excel may really be most appropriate – but how can you create, validate and use off-the-shelf programs in your regulated environment without violating the provisions of Part 11?

FDA is well aware of the wide utility of spreadsheets, but expects the controls to be in place to ensure that spreadsheets used in GxP processes are validated and compliant with 21 CFR Part 11. In today’s environment of renewed FDA enforcement of Part 11, uncontrolled spreadsheets represent an area of increased regulatory concern and scrutiny.

You can learn to confidently harness the versatility and functionality of spreadsheets. You, your colleagues and your organization can take advantages of all of the benefits of the ease-of-use and economy spreadsheets offer – and still remain in compliance with FDA’s regulatory requirements. Key points that will be covered include:

How to design your spreadsheets to facilitate compliance and validation
The part of a spreadsheet with the highest regulatory risk - and how to address it
How FDA validates their own spreadsheets
The expected contents of a spreadsheet validation package
How to write spreadsheet requirements and specifications to facilitate good testing
What must be included during spreadsheet validation testing
The most common deviations discovered during spreadsheet validations, and how to focus your testing to detect these common mistakes

Presented by Daniel Waterman, Validation Manager, Ofni Systems
Thursday, February 14, 2012; 1:00 pm - 2:30 pm EST (GMT - 5)
Teleconference, Presented by FOI Services

Recent Events

Desktop Databases: 21 CFR Part 11 Compliance

Daniel Waterman addressed validation and 21 CFR 11 with regard to usage of desktop databases, such as MS Access. Hundreds of 483's and warning letters are received each year by companies who did not design or validate their databases and spreadsheets to meet Part 11 requirements. By properly securing your databases, you can allow a much wider audience to use and benefit from every database within the organization.

Learn what the FDA will look for during audits
How to define requirements quickly.
How to document inputs, code and security settings.
Details on when and where to use electronic signatures.
Inactivity timeouts, and controls for users and passwords.
Managing change control and common change control mistakes to avoid.

Presented by Daniel Waterman, Validation Manager, Ofni Systems
Thursday, January 10, 2012; 1:00 pm - 2:30 pm EST (GMT - 5)
Teleconference, Presented by FOI Services

Spreadsheet Validation 101 :
Create and Validation FDA Compliant Spreadsheets

Tyson Mew, President of Ofni Systems, and Daniel Waterman, Validation Manager for Ofni Systems spoke at IVT's 12th Annual Computer and Software Validation conference in Philadelphia, PA, from April 26 through April 28. Ty and Daniel will present
Spreadsheet Validation 101 : Create and Validation FDA Compliant Spreadsheets on Wednesday, April 27 at 8:45 AM - 12:15 PM .

Easy-to-create and surprisingly powerful and flexible tools for data storage, spreadsheets are so common that they can almost seem invisible. However, GxP data stored within spreadsheets must be maintained in accordance with all applicable regulatory rules, especially 21 CFR 11; Electronic Records Electronic Signatures. The FDA is aware of the usefulness of spreadsheets, but expects controls to be in place to ensure that spreadsheets used in GxP processes are compliant with 21 CFR 11 and are validated. As FDA enforcement of 21 CFR 11 increases, uncontrolled spreadsheets represent an area of increased regulatory concern.

Presented by Tyson M. Mew, President, and Daniel Waterman, Validation Manager, Ofni Systems, Inc.
12th Annual Computer and Software Validation
April 26 - 28, 2011, Philadelphia , PA
Presented by IVT

Desktop Databases: 21 CFR Part 11 Compliance

Learn what the FDA will look for during audits
How to define requirements quickly.
How to document inputs, code and security settings.
Details on when and where to use electronic signatures.
Inactivity timeouts, and controls for users and passwords.
Managing change control and common change control mistakes to avoid.

Presented by Daniel Waterman, Validation Manager, Ofni Systems
Tuesday, March 8, 2011; 1:00 pm - 2:30 pm EST (GMT - 5)
Teleconference, Presented by FOI Services

Spreadsheet Validation: 21 CFR Part 11 Compliance

How to design your spreadsheets to facilitate compliance and validation
The part of a spreadsheet with the highest regulatory risk - and how to address it
How FDA validates their own spreadsheets
The expected contents of a spreadsheet validation package
How to write spreadsheet requirements and specifications to facilitate good testing
What must be included during spreadsheet validation testing
The most common deviations discovered during spreadsheet validations, and how to focus your testing to detect these common mistakes

Presented by Daniel Waterman, Validation Manager, Ofni Systems
Thursday, February 3, 2011; 1:00 pm - 2:30 pm EST (GMT - 5)
Teleconference, Presented by FOI Services

Automate the Validation Process

Automation can be an excellent technique to improve the overall quality of your validation processes while decreasing the time spend on each validation project. Ofni Systems is a leader in validation automation. Ty Mew, the president of Ofni Systems, will give you all of the information you need to begin to automate your computer validation process. Key points that will be covered include:

Getting Started – Preparing to Automate your Validation Practices

Prepare templates for documents and certain types of systems
Formalize your strategy in a Validation Master Plan
Implement best practices for lean project management

Automate the Generation of Validation Documents

Collect testable requirements and lists of testable objects
Integrate risk assessments into the process
Automatic generation, tracking and updating of the requirements traceability matrix

Test Cases and Test Plans

Input testing, challenge testing, unit and workflow test cases
Automate common test scripts with mini-test cases
Create specific test cases for use with change control

Protocol Execution, Documentation and Managing Deviations

Paper versus electronic execution
Capturing actual results and screen shots for maximum effectiveness
Generating, processing and closing test and script deviations

Bonus Material

Articles describing the methodologies discussed and how they were applied
Sample validation documents created using automation

Presented by Tyson M. Mew, President, Ofni Systems, Inc.
16th Annual Validation Week
October 26, 2010, Philadelphia, PA
Presented by IVT

Spreadsheet Validation: 21 CFR Part 11 Compliance

How to design your spreadsheets to facilitate compliance and validation
The part of a spreadsheet with the highest regulatory risk - and how to address it
How FDA validates their own spreadsheets
The expected contents of a spreadsheet validation package
How to write spreadsheet requirements and specifications to facilitate good testing
What must be included during spreadsheet validation testing
The most common deviations discovered during spreadsheet validations, and how to focus your testing to detect these common mistakes

Presented by Daniel Waterman, Validation Manager, Ofni Systems
Wednesday, September 1, 2010; 1:00pm – 2:30pm EDT (GMT – 4)
Teleconference, Presented by FOI Services

Prepare for FDA CSV Inspections – Review of Recent Enforcement Actions, 483's and Warning Letters

The FDA has been expanding their audit programs and the number of observations related to validation problems has been steadily increasing. New requirements for Risk Assessments have been appearing, as well as a number of observations related to change control This session will focus on what the agency is looking for in your validation program by reviewing recent 483's and warning letters related to computer system validations. Key points that will be covered include:

Current FDA Requirements and Expectations for Validation
Review of recent 483's and Warning letters
Consequences of Validation Gaps
A checklist of the top observations to avoid

Presented by Tyson M. Mew, President, Ofni Systems, Inc.
11th Annual Computer and Software Validation
April 21, 2010, San Diego, CA
Presented by IVT

Automate Your CSV Process – Templates, Tools, & Tricks

This course will discuss:

Getting Started – Preparing to Automate your CSV Practices

Discuss why CSV is well-suited to automation
Preparing templates for documents and certain types of systems
Determine and execute your testing strategy
Formalize your strategy in a Validation Master Plan
Implement best practices for lean project management

Automation of CSV Document Generation

Breaking down systems into discrete validatable objects
Collecting testable requirements
Automatically create your list of testable objects
Generating Design Specifications directly from source code
Integrating Risk Assessments into the process
Automatic generation, tracking and updating of the Requirements Traceability Matrix

Test Cases and Test Plans

How much testing is enough? Testing based on Risk Assessments
Input testing, Challenge Testing, Unit & Workflow test cases
Automating common test scripts with mini-test cases
Create specific test cases for use with change control
Auto-creation of test scripts from your requirements

Protocol Execution, Documentation and Managing Deviations

Paper vs. Electronic execution
Capturing actual results and screen shots for maximum effectiveness
Generating, processing and closing test and script deviations

Interactive Exercise: Case Studies of CSV Automation Success Stories

Several case studies will be presented to demonstrate how different types of validation projects were automated using the techniques described above. We will also discuss how the FDA is using automation for spreadsheet validation in their own labs.

Presented by Tyson M. Mew, President, Ofni Systems, Inc.
11th Annual Computer and Software Validation
April 22, 2010, San Diego, CA
Presented by IVT

21 CFR Part 11 Compliance and Validation for Databases and Spreadsheets

Hundreds of 483's and warning letters are received each year by companies who did not design or validate their databases and spreadsheets to meet Part 11 requirements.

In this webinar you will learn how to implement Part 11 requirements in databases (Access, Oracle, and SQL Server) and Excel spreadsheets.

This presentation will provide the instructions, and documentation to ensure full compliance with 21 CFR Part 11, including:

Strategies for how to document and validate Access databases and other software applications based on databases.
How to add audit trails to databases and spreadsheets
How to define requirements quickly.
Managing change control and common change control mistakes to avoid.
How to document inputs, code and security settings.
How to properly secure the data and code.
Access security settings for multiple users.
Common settings applied to limit user actions.
Details on when and where to use electronic signatures.
Advanced techniques for adding electronic signatures
Inactivity timeouts, and controls for users and passwords.
Tips for efficient database testing.
Learn about how the FDA secures their own databases and spreadsheets

December 17, 2009
e-Conference, Presented by the Executive Conference Corporation

How to Validate Device and Computer Software

Computer software validation has been a major issue for medical device manufacturers and is one of the leading causes of 483 observations, warning letters and product recalls. There are many different types of computer hardware and software found in the medical device industry, including:

COTS (Commercial Off-The-Shelf) applications
Custom in-house applications (databases and spreadsheets, web apps, etc)
Software embedded in medical devices
Software used to create or manufacture devices

All of the above must be validated for intended use and be under strict change control. The risk to patients can be severe for even small software bugs, and the cost of legal actions or product recalls can be financially devastating. The following topics will be covered in detail:

A review of recent enforcement actions as a result of inappropriate computer system validations.
The basics of computer software validation and what is expected in any validation effort.
A presentation of Ofni System's methodology for how we create functional requirements, design specifications and test cases.
Education for users about specific hot spots, including Change Control and Risk Assessments.
A discussion of new technologies for automated testing and electronic protocol execution.

July 8, 2009
e-Conference, Presented by the Clinical Device Group

How to Conduct a GAP Analysis of your CSV Program
Use of Macros and Spreadsheets in Regulated Environments

Tyson Mew, president of Ofni Systems will speak at IVT's 10th Annual Computer and Software Validation conference.

May 18-20th, 2009
Presented by IVT

21 CFR Part 11 Compliance and Validation for MS Access Databases

Mr. Tyson Mew will address validation and 21 CFR 11 with regard to usage of Access databases. By properly securing your databases, you can allow a much wider audience to use and benefit from every database within the organization. The following topics will be covered in detail:

How to add audit trails to any part of the database
How to properly secure the data and code
Access database security settings for multiple users
Common settings to apply to limit user actions
Learn what the FDA will look for during audits
Managing change control and common mistakes to avoid
Details on when and where to use Electronic Signatures
Database testing and techniques for software validation

Attendees will receive instructions for how to apply controls to their own access programs. In additions, attendees may download sample code and validation documents for their own use.

February 18, 2009
e-Conference, Presented by the Clinical Device Group

How to Make Excel Part 11 Compliant

This conference will address validation and part 11 with regard to your usage of Excel spreadsheets. You will learn what your options are and how to address the issues for the different categories of spreadsheets use. He will address:

What Excel is used for
Different categories of spreadsheets
Relevant regulations and history
Excel's lack of compliance features
Where we are today with respect to Part 11 and enforcement
Options available to address Excel's shortfalls
Applying those options to the different categories of spreadsheets
Managing the whole process
How to approach the issue if it's an emergency and you have no money/time/resources

February 4, 2009 at 11:00 am
e-Conference, Presented by the Clinical Device Group

Validation of Excel Spreadsheets in a Regulated Environment

Dennis Cantellops, QA Manager for the FDA Office of Regulator Affairs, San Juan District will give a presentation on "Validation of Excel Spreadsheets in a Regulated Environments."

Many lab decisions being made based on the information in Excel spreadsheets. Excel spreadsheets can be as simple as a calculator or as complex as a custom made computerized solution. The use of this tool however might become a regulatory nightmare if they proliferate unchecked within any organization. The FDA is aware of the usefulness of Excel spreadsheets, but expects controls to be in place to avoid wrong decisions being made based on "on-the fly" worksheets that were created for one-time use. This session will address these concerns and offer strategies and approaches for response.

A central part of this discussion will detail their experience using ExcelSafe with their regulatory spreadsheets. The FDA Office of Regulator Affairs, San Juan District is implementing ExcelSafe, Ofni Systems' tool to provide audit trails, user level security, electronic signatures and other technological tools, allowing MS Excel spreadsheets to be compliant with 21 CFR 11. Ofni Systems President Tyson Mew will be available following the presentation to answer any questions about ExcelSafe and spreadsheet validation.

January 29, 2009 at 9:00 am
Presented by Interphex

IVT Validation Week at the DoubleTree Hotel

FDA Validation Inspections and Latest Trends - FDA Validation Inspections and Latest Trends - The presentation will discuss FDA audit observations relating to validation. In particular, the presentation will examine why validation is consistently one of the most common observations reported in FDA audits and which types of validations generate warning letters. In particular, the presentation will focus on Computer System Validation, Equipment Validation and Cleaning Validation.

Computer System Remediation & Validation for Regulatory Inspection - A Case Study - This presentation will outline a computer software validation compliance program. In particular, the presentation will demonstrate methods to generate validation documentation, and provide validation solutions for commonly used software like MS Access and MS Excel. The presentation will also include a validation case study review.

Philadelphia, PA
October 21 - October 23, 2008

2008 SNM Annual Meeting

Development of software tools for managing data in multi-center clinical trials - Many cancer patients have follow-up imaging and Good Clinical Practice (GCP) requires consistent imaging over time. Likewise, it is equally important in clinical research to have consistent acquisition parameters and the ability to search and retrieve patient and scanning information. Traditional PACS and HIS/RIS systems provide limited access to these parameters. To address these needs, Dana Farber developed a comprehensive database for all PET and PET/CT procedures using MS Access 2000 to provide common accessibility with minimal costs.

Rapid validation of nuclear medicine imaging software utilized in the context of clinical trials - Nuclear medicine imaging is important tool for the development of new therapeutic drugs and might accelerate the approval of these drugs. However, data submitted to the FDA in support of drug applications must comply with regulations such as Good Clinical Practice (GCP) and 21 CFR Part 11. These regulations require Computer Systems Validation of software used to generate the results. It is challenging for the academic community to achieve compliance given the time, effort, expertise, and financial investment that is required. This presentation reviewed the validation process, the regulatory requirements, and demonstrated an approach and software used to accelerate CSV to improve regulatory compliance.

New Orleans, LA
June 14 - June 18, 2008

Mi Co User Days 2008

Validation of Mi-Forms User Forms - Ofni Systems president Ty Mew and Mi-Co CEO Greg Clary gave a presentation on the Validation of Mi Forms user forms on April 23 at Mi-Co User Days. The presentation focused on using Ofni Systems FastVal Document Generator to automate the process of validating Mi Forms user forms. Ofni Systems was a Silver Sponsor of Mi-Co User Days 2008. Ofni Systems is Mi-Co's preferred vendor for validation services.

Research Triangle Park, NC
April 22 - April 23, 2008

Audio Seminar

Validation and Use of MS Access Databases in GxP and Part 11 Environments - 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.