News

READ THIS! - FDA announces an increased emphasis on enforcement of 21 CFR 11. More

READ THIS! - Ofni Systems has noticed FDA increasing warning letter citations for spreadsheets. More

April 16-18, 2012 - Ofni Systems will be at IVT's 13th Annual Computer and Software Validation conference in San Diego, CA. More

April 10, 2012 - Ofni Systems will be presenting at the 19th Annual ISPA CASA Life Scients Technology show in Raleigh, NC. More

February 14, 2012 - Ofni Systems Validation Manager Daniel Waterman will present a teleconference "Spreadsheet Validation:
21 CFR Part 11 Compliance" for FOI Services. More

January 10, 2012 - Ofni Systems Validation Manager Daniel Waterman presented a teleconference "Desktop Databases: 21 CFR Part 11 Compliance" for FOI Services. More

January 9, 2012 - Get started on your 2012 validation commitments! Ofni Systems can help you complete your projects on-time. More

April 27, 2011 - Ty Mew and Daniel Waterman presented "Spreadsheet Validation 101" at IVT's 12th Annual Computer and Software Validation conference in Philadelphia, PA. More

March 8, 2011 - Ofni Systems Validation Manager Daniel Waterman presented a teleconference "Desktop Databases: 21 CFR Part 11 Compliance" for FOI Services. More

February 3, 2011 - Ofni Systems Validation Manager Daniel Waterman presented a teleconference "Spreadsheet Validation: 21 CFR Part 11 Compliance" for FOI Services. More

October 26, 2010 - Ty Mew presented at"Automate the Validation Process" at IVT's 16th Annual Validation Week in Philadelphia, PA. More

October 8, 2010 - Ofni Systems announces FastVal V2.0. More

September 1, 2010 - Ofni Systems Validation Manager Daniel Waterman presented a teleconference on "21 CFR Part 11 Compliance & Validation for Spreadsheets" with FOI Services. More

May 26, 2010 - Ofni Systems presented at the Computer and Software Validation EU conference in Dublin, Ireland. More

May 26, 2010 - CDER announces an increased emphasis on enforcement of 21 CFR 11. More

April 29, 2010 - Ofni Systems exhibited at the SQA 26th Annual Meeting and Quality College in Cincinnati, OH, April 25 - 30. More

April 23, 2010 - Ofni Systems president Ty Mew gave presentations on Preparing for FDA CSV Inspections and Automating CSV Processes at IVT's 11th Annual Computer and Software Validation conference in San Diego, CA. More

February 16, 2010 - Ofni Systems announces a validation package for KFComm by Spectrum Labs. More

January 4, 2010 - Get started on your 2010 validation commitments! Ofni Systems can help you complete your projects on-time. More

December 3, 2009 - On December 17, 2009, the Executive Conference Corporation gave a presentation on "21 CFR Part 11 Compliance and Validation for Databases and Spreadsheets". Ofni Systems president Tyson Mew will be the featured speaker. More

September 8, 2009 - Ofni Systems announces ExcelSafe Version 2.1. More

September 1, 2009 - Ofni Systems expands their training offerings. More

August 17, 2009 - Ofni System announces their Spreadsheet Validation package. More

July 8, 2009 - The Clinical Device group gave a presentation on "How to Validate Device and Computer Software". Ofni Systems president Tyson Mew was the featured speaker. More

May 18-20, 2009 - Tyson Mew, president of Ofni Systems, spoke about conducting GAP analysis of CSV programs and using macros and spreadsheets in regulated environments at IVT's 10th Annual Computer and Software Validation conference. More

April 7, 2009 - Ofni Systems was at the 25th SQA Annual Meeting. Tyson Mew was available to answer questions about creating Part 11 compliant databases, Excel spreadsheet security and automating the validation process. More

March 9, 2009 - Ofni Systems announces ExcelSafe for Oracle. More

February 18, 2009 - The Clinical Device group presented "Access and Part 11 Compliance". Ofni Systems president Tyson Mew was the featured speaker. More

February 4, 2009 - The Clinical Device group presented "How to Make Excel Part 11 Compliant." Derrick Wimmer was the featured speaker. Ofni Systems provided all conference attendees with a free trial copy of ExcelSafe. More

January 29, 2009 - Dennis Cantellops, QA Manager for the FDA Office of Regulator Affairs, San Juan District, gave a presentation on "Validation of Excel Spreadsheets in a Regulated Environment" and discussed the FDA's use of ExcelSafe. More

January 22, 2009 - Ofni Systems president Tyson Mew gave presentations on "Conduct a GAP Analysis of your CSV Program" and "Use Macros and Spreadsheets in a Regulated Environments" at IVT's 10th Annual Computer and Software Validation on May 18-20, 2008 in Washington D.C. More

October 30, 2008 - Ofni Systems president Tyson Mew presented on the Proper Use and Validation of Excel Spreadsheets in FDA Regulated Environments at ISPE Puerto Rico Chapter Program, in San Juan, PR. More

October 23, 2008 - Ofni Systems president Tyson Mew spoke at IVT Validation Week, in Philadelphia, PA. More

August 15, 2008 - ExcelSafe Version 2.0 is released. More

June 12, 2008 - Ofni Systems presented with the Dana-Farber Cancer Institute at the Society for Nuclear Medicine in New Orleans, LA. More

June, 2008 – A new article, Validation of MS Access Spreadsheets by Ty Mew, published by askaboutValidation.com. More

May, 2008 – A new article, Validation of MS Excel Spreadsheets by Ty Mew, chosen as article of the month by askaboutValidation.com. More

April 23, 2008 – Ofni Systems presents Validation of Mi-Forms for use in Clinical Trials & Healthcare at Mi-Co 2008 User Days. Ofni Systems is a Silver Sponsor of Mi-Co's 2008 User Days. More

March 27, 2008 – Changes in software development documentation in GAMP 5. More

January 31, 2008 – ExcelSafe Enterprise for SQL Server has been released. More

January 2, 2008 – ExcelSafe Pro, which provides Part 11 compliance for MS Excel is released. More

October, 2007 – The FastVal Validation Document Generator has been released.  More

September, 2007 – Ofni Systems completes a validation project for Mi-Co.

August, 2007 - The beta version of the FastVal Validation Document Generator has been released.

June, 2007 - Ofni Systems becomes a member of CDISC.

July 21, 2006 - Bayer Healthcare selects Ofni Systems to upgrade and validate their QC Sample Submission tracking software.

July 12, 2006 - The Ofni Startup program is released to production.

June 1, 2006 - The MedWatch Adverse Events Reporter software is released. More

April 3-7, 2006 - Ofni Systems provides Part 11 training and software for the Dana-Faber Cancer Institute at Harvard University

March 30 -31 - Ofni Systems conducts Part 11 Training for developers in Raleigh, NC

March 27, 2006 - Announcement of our latest audio conference, "Validation and Use of MS Access Databases in GxP and Part 11 Environments", hosted by Dr. Ludwig Huber and Lab Compliance.

March 22, 2006 - Ofni Systems receives FDA approval letter for our new MedWatch Form 3500A and tracking software.

January 26, 2006 - Two new training courses for building compliant applications have just been announced.

October 6, 2005 - The latest version of the Part 11 Toolkit has been released! This version is packed with new features for enhanced security and data protection, while making it easier for users to search for the information they need.

July 19, 2004 - Ofni Systems to speak on MS Access compliance and overall risk assessments at the IVT Lab Compliance conference in Philadelphia, PA on August 17, 2004.

February 8, 2004 - Ofni Systems begins it's new Developer Training courses for implementation of the Part 11 Toolkit. This course allows outside developers to build or update access programs to include Part 11 Toolkit functionality at any time.

July 1, 2003 - The Part 11 Toolkit (Version 2) has been officially released.

April 15, 2003 - The beta version of the Part 11 Toolkit (Version 2) has been released. This new version contains many improvements to simplify the installation and use for developers.