June 22, 2008 - GxP Auditor, which manages compliance audits, is released. More
June 12, 2008 - Ofni Systems presents with the Dana-Farber Cancer Institute at the Society for Nuclear Medicine in New Orleans, LA. More
June, 2008 – Ofni System completes validation projects for Biogen Idec, Bayer Healthcare and Dana-Farber Cancer Institute.
June, 2008 – A new article, Validation of MS Access Databases 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
December, 2007 – Ofni Systems completes a validation project for SOS.
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. Please contact us for information on participating in the beta process.
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. |
