Raleigh North Carolina – Tyson Mew, president of Ofni Systems, will speak at the Computer and Software Validation EU conference in Dublin, Ireland from September 27 through September 29. The event showcases the validation process for computer systems and software. Computer and software validation (CSV) has remained a FDA hot button over the last decade in the GXP environment (manufacturing, laboratory and clinical). Today, new approaches, such as EU’s Annex 11 and ASTM 2500, have taken the forefront in assisting organizations with CSV compliance. In this ‘create-your-own conference’ format, attendees build their own event to suit their specific validation needs, Whether working in traditional pharmaceuticals, emerging biotechnology or the medical device industry, participants take away leading edge information that can be immediately implemented.
Ofni Systems is sponsor of the conference. Ty Mew and Ofni Systems will also be available throughout the conference to discuss computer validation.
About Ofni Systems
Registration information for the 11th Annual Computer and Software Validation conference is available.
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.
Ofni Systems, Inc.
Phone: (919) 844 – 2494