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.

Ofni Systems Exhibit at the SQA 26th Annual Meeting, April 26-28 2010

Ofni Systems exhibited their software and services at the SQA 26th Annual Meeting in Cincinnati, OH. Ofni Systems informed SQA members about Ofni Systems compliance and validation services and products. In addition, Ty Mew, the president of Ofni Systems, was available to answer questions about creating Part 11 compliant databases, Excel spreadsheet security and automating the validation process.

Ty Mew wants to thank all of our friends who stopped by our booth during the conference and looks forward to working with you in the future.

Any parties who would be interested in having Mr. Mew speak on topics relating to computer validation are encouraged to contact Ofni Systems.

About Ofni Systems
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 software for generating and executing validation documents, and have been providing professional validation servicesusing FastVal since 2006. 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.

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. 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

2009 SQA Annual Meeting Press Release

Raleigh North Carolina – Ofni Systems will be at the 25th SQA Annual Meeting, located at the Town and Country Resort and Convention Center in San Diego, California on April 19 – 24, 2009. Ofni Systems will have an information booth to inform SQA members about Ofni Systems compliance and validation services and products. Ty Mew will be available to answer questions about creating Part 11 compliant databases, Excel spreadsheet security and automating the validation process.

For more information about the 25th SQA Annual Meeting, please visit their website at www.SQA.org.

About Ofni Systems
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 software for generating and executing validation documents, and have been providing professional validation servicesusing FastVal since 2006. 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.

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. 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