Ofni Systems presents at numerous conferences and workshops on Part 11 and regularly conducts training sessions for organizations to educate employees about the specific requirements of the rule and how to incorporate it into daily practices.
Contact us to set up a workshop or consulting session.
Upcoming Events
Feburary 2009 - Ofni Systems president Tyson Mew will give a presention "Part 11 Compliance and Validation of Access DB."
Recent Events
IVT Validation Week at the DoubleTree Hotel
FDA Validation Inspections and Latest Trends - FDA Validation Inspections and Latest Trends - The presentation will discuss FDA audit observations relating to validation. In particular, the presentation will examine why validation is consistently one of the most common observations reported in FDA audits and which types of validations generate warning letters. In particular, the presentation will focus on Computer System Validation, Equipment Validation and Cleaning Validation.
Computer System Remediation & Validation for Regulatory Inspection - A Case Study - This presentation will outline a computer software validation compliance program. In particular, the presentation will demonstrate methods to generate validation documentation, and provide validation solutions for commonly used software like MS Access and MS Excel. The presentation will also include a validation case study review.
Philadelphia, PA
October 21 - October 23, 2008
2008 SNM Annual Meeting
Development of software tools for managing data in multi-center clinical trials - Many cancer patients have follow-up imaging and Good Clinical Practice (GCP) requires consistent imaging over time. Likewise, it is equally important in clinical research to have consistent acquisition parameters and the ability to search and retrieve patient and scanning information. Traditional PACS and HIS/RIS systems provide limited access to these parameters. To address these needs, Dana Farber developed a comprehensive database for all PET and PET/CT procedures using MS Access 2000 to provide common accessibility with minimal costs.
Rapid validation of nuclear medicine imaging software utilized in the context of clinical trials - Nuclear medicine imaging is important tool for the development of new therapeutic drugs and might accelerate the approval of these drugs. However, data submitted to the FDA in support of drug applications must comply with regulations such as Good Clinical Practice (GCP) and 21 CFR Part 11. These regulations require Computer Systems Validation of software used to generate the results. It is challenging for the academic community to achieve compliance given the time, effort, expertise, and financial investment that is required. This presentation reviewed the validation process, the regulatory requirements, and demonstrated an approach and software used to accelerate CSV to improve regulatory compliance.
New Orleans, LA
June 14 - June 18, 2008
Mi Co User Days 2008
Validation of Mi-Forms User Forms - Ofni Systems president Ty Mew and Mi-Co CEO Greg Clary gave a presentation on the Validation of Mi Forms user forms on April 23 at Mi-Co User Days. The presentation focused on using Ofni Systems FastVal Document Generator to automate the process of validating Mi Forms user forms. Ofni Systems was a Silver Sponsor of Mi-Co User Days 2008. Ofni Systems is Mi-Co’s preferred vendor for validation services.
Research Triangle Park, NC
April 22 - April 23, 2008
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
August 23, 2007 |
