4th Global QA Conference & 30th SQA Annual Meeting

Tyson Mew, president of Ofni Systems, will be at the 4th Global QA Conference & 30th SQA Annual Meeting in Las Vegas, NV, from April 6–11, 2014. Ty will be demonstrating how ExcelSafe gives your analytical spreadsheets the controls and security features needed for 21 CFR Part 11 compliance.

Learn how to Create and Validate Spreadsheets in FDA-Regulated Environments

Easy-to-create and surprisingly powerful and flexible tools for data storage and processing, spreadsheets are so common that they can almost seem invisible. However, GxP data stored or processed with spreadsheets must be maintained in accordance with all applicable regulatory requirements, especially 21 CFR 11, Electronic Records Electronic Signatures. The FDA is aware of the usefulness of spreadsheets but expects controls to be in place that ensure 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 QA concern.

Society of Quality Assurance

SQA’s 4th Global QA Conference & 30th Annual Meeting is a six-day conference for discussion of emerging trends and issues affecting Quality Assurance practices in regulated industry. Hot topics include Computer Validation, Scientific Archiving, Industry Best-Practices, and Compliance. The conference will feature a number of industry expert talks and opportunities for knowledge exchange among QA peers from around the globe.

Ty Mew and Ofni Systems will be available throughout the conference to discuss spreadsheet and software compliance and validation.
Registration information for the 14th Annual Computer and Software Validation conference is available here.

Excel Spreadsheet Validation 101 — Proven Techniques for FDA Compliant Spreadsheets

Tyson Mew, president of Ofni Systems, will speak at IVT’s 14th Annual Computer and Software Validation conference in Philadelphia, PA, from April 17 through April 19. On Thursday April 18, 2013, Ty Mew will be a featured speaker, giving the presentation:  Excel Spreadsheet Validation 101 — Proven Techniques for FDA Compliant Spreadsheets.

Learn how to Create and Validate Spreadsheets in FDA Regulated Environments

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.

Institute for Validation Technology

IVT’s 14th Annual Computer and Software Validation conference is a three-day conference to discuss evolving computer and software validation practices. From the emergence of virtual networks, cloud computing and social media, the urgency of securing data integrity and complying with global regulations has never been greater. This conference aligns global regulations, best practices and case studies featuring the best CSV speakers to discuss developing, implementing and maintaining best validation practices in regulated environments.

Ty Mew and Ofni Systems will be available throughout the conference to discuss validation.

Registration information for the 14th Annual Computer and Software Validation conference is available.

Spreadsheet Validation: 21 CFR Part 11 Compliance – 2/3/2011

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 GxP environments without violating the provisions of Part 11?

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.

Register for FOI Services’ Spreadsheet Validation: 21 CFR Part 11 Compliance!

You can learn how to harness the versatility and functionality of spreadsheets, giving you and your organization all of the benefits of electronic data systems while remaining compliant with all regulatory requirements.

On Thursday, February 3 at 1:00 EDT, join FOI Services and Ofni Systems for a 90-minute teleconference to gain practical knowledge about spreadsheet compliance and validation, including specific, practical advice on creating compliant spreadsheets, spreadsheet validation methodology and maintaining spreadsheets in GxP environments.

What You’ll Learn

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

What You’ll Get

• Tips to facilitate compliant spreadsheet design
• A checklist to determine if your spreadsheets are compliant with 21 CFR 11
• Practical examples of requirements, specifications and test scripts
• Links to a free sample spreadsheet validation package, including functional requirements, design specification and executed test scripts.
• A free copy of “MS Excel Spreadsheet Validation”
• A trial copy of ExcelSafe, which provides audit trails, password protection, user-level security and electronic signatures to MS Excel spreadsheets
• An experienced and approachable instructor
• Time for questions and answers

Audience Suitability

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

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

Ofni Systems Presentation “Proper Use & Validation of Excel Spreadsheets in an FDA Regulated Environments”

Raleigh North Carolina – Tyson Mew, president of Ofni Systems spoke at QCSV Inc. and the Regulatory Compliance Committee of the Medical Device Cluster Conference on the Proper Use & Validation of Excel Spreadsheets in an FDA Regulated Environments on October 30. The presentation was given in conjunction with Dennis Cantellops, QA Manager for the FDA Office of Regulator Affairs, San Juan District. 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.

The presentation started by outlining the FDA’s plans to increase inspectors and inspections, specifically focused on an increased interest in use of spreadsheets in regulated environments. Specific examples of audit observations relating to spreadsheets were discussed. Specific techniques to improve spreadsheet validation were discussed along with a general outline of a spreadsheet validation project.

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.

Media Contact
Tyson Mew
President
Ofni Systems, Inc.
Phone: (919) 844 – 2494