21 CFR Part 11 Compliance and Validation for MS Access Databases – 3/8/2012

Ofni Systems will address validation and 21 CFR 11 with regard to usage of desktop databases, such as MS Access. Hundreds of 483s 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.

The following topics will be covered in detail:

• 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.

On Tuesday, March 8 at 1:00 EDT, join FOI Services and Ofni Systems for a 90-minute teleconference to gain practical knowledge about desktop database compliance and validation, including specific, practical advice on creating compliant desktop databases, validation methodology, and maintaining desktop databases in GxP environments.

Audience Suitability

• Managers and staff who are responsible for providing valid GxP data for databases
• Anyone who designs desktop databases for use in GxP environments
• Regulatory professionals who must defend the compliance of desktop databases
• Quality professionals who may audit desktop databases or are responsible for administrating procedural requirements required for spreadsheet compliance
• Information technology professionals responsible for administrating files or network locations storing desktop databases containing GxP data
• Computer validation professionals working with desktop databases for use in GxP environments
• Executives who are planning their company’s futures

About Ofni Systems

Ofni Systems is an industry leader for 21 CFR Part 11 compliance. Their products for Part 11 compliant databases and spreadsheets are used by pharmaceutical, biotech, and medical device companies across the globe, while it’s products for computer validation, auditing, and FDA submissions ensure that their clients meet every requirement for electronic records and electronic signatures. The company provides live desktop support for superior customer support and training and has been providing solutions to their clients since 1999. For more information, call (919) 844-2494 or visit www.OfniSystems.com.

Designing & Evaluating 21 CFR 11 Compliant Access Databases

Ofni Systems will address validation and 21 CFR 11 with regard to usage of desktop databases, such as MS Access. Many drug and device firms find that Microsoft Access is a perfect software package for database management with familiar, easy-to-use features, good functionality and smooth integration with other common software. But what should you do to be sure your Access databases are Part 11 compliant? FDA requires evidence of your validation efforts, and regulated industry routinely sees the consequences of non-compliance-–every year, hundreds of 483s and warning letters are issued to companies who did not design or validate their databases to meet these requirements. If you’re using Microsoft Access for your databases, you have very specific Part 11 concerns, and you need to take special care to ensure you have the appropriate audit trails, security, and electronic signature requirements in place.

The following topics will be covered in detail:

• 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.

On Tuesday, January 10, 2012 at 1:00 EDT, join FOI Services and Ofni Systems for a 90-minute teleconference to gain practical knowledge about desktop database compliance and validation, including specific, practical advice on creating compliant desktop databases, validation methodology and maintaining desktop databases in GxP environments.

About Ofni Systems

Ofni Systems is an industry leader for 21 CFR Part 11 compliance. Their products for Part 11 compliant databases and spreadsheets are used by pharmaceutical, biotech, and medical device companies across the globe, while it’s products for computer validation, auditing, and FDA submissions ensure that their clients meet every requirement for electronic records and electronic signatures. The company provides live desktop support for superior customer support and training and has been providing solutions to their clients since 1999. For more information, call (919) 844-2494 or visit www.OfniSystems.com.

21 CFR Part 11 Compliance and Validation for Databases and Spreadsheets

The Executive Conference Corporation will present an e‑conference on 21 CFR Part 11 Compliance and Validation for Databases and Spreadsheets on December 17, 2009 from Noon to 1:30 pm ET. The e‑conference will be presented by Mr. Tyson Mew.

This conference has already occurred. Please contact Ofni Systems if you would be interested in setting up your own training session on 21 CFR Part 11 Compliance and Validation for databases and spreadsheets.

Learn to Make Your Databases Compliant

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

About Tyson Mew

Tyson M. Mew is President of Ofni Systems, Inc., a software provider and Part 11 consulting firm. He has a strong background in software development and computer system validation, and has spoken at many conferences, webinars, audio conferences and workshops on FDA requirements for electronic records and signatures. Ty regularly conducts training sessions for organizations to educate employees about the specific requirements of 21 CFR Part 11 and Computer Systems Validation. He is an active member of ISPE, DIA, SQA and the Triangle PEERS group.

Ofni Systems is a leader in providing regulatory compliance solutions for pharmaceutical, biotech and medical device companies. They are the creators of ExcelSafe for Excel spreadsheet security and the Part 11 Toolkit for compliant databases. They also are the creators of the FastVal Validation Document Generator software for generating and executing validation documents, and have been providing professional validation services using FastVal since 2006.

Ofni Systems is also highly acclaimed for their expertise with 21 CFR Part 11 compliance. They are frequent speakers on Part 11 at conferences, meetings and webinars, and have provided training for thousands of employees to help implement the requirements. For more information, contact Ofni Systems at (919) 844-2494, via email at Info@OfniSystems.com, or by visiting www.OfniSystems.com.

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

e-Conference, Presented by the Executive Conference Corporation

21 CFR Part 11 Compliance and Validation for MS Access Databases – 2/18/2009

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

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.

Order Recording